A Report on the Clinical Research Industry Cluster in Southeastern

A Report on the Clinical Research Industry Cluster in
Southeastern North Carolina
Created February 2013. Updated May 2014.
The southeastern region’s NC Coast Clinical Research Initiative is a collaborative effort between
clinical research companies, healthcare providers, economic developers, UNC Wilmington, and the
North Carolina Biotechnology Center Southeastern Office, who identified both a need and a desire to
strengthen the clinical research (CR) community in our area. The goals of the NC Coast Clinical
Research Initiative, an economic development initiative, are to create greater cohesion between members
of the clinical research community, to promote the clinical research cluster in the region and beyond, and
to increase physician-led clinical research trials in the region, all for economic, societal, and health
benefit to the southeastern region of North Carolina.
The North Carolina Biotechnology Center provides long-term economic and societal benefits to North
Carolina through support of biotechnology research, business, education and strategic policy statewide.
Headquartered in Research Triangle Park, the Center has five regional offices, including the
Southeastern Office in Wilmington, focused on regional biotechnology economic development.
A Report on the Clinical Research Industry in Southeastern NC
The Clinical Research industry cluster is vital to Southeastern North Carolina, supporting
knowledge-sector jobs to strengthen the region’s diverse economy. Pharmaceutical Product
Development (PPD), the third largest contract research organization (CRO) in the world, is
headquartered in downtown Wilmington. PPD’s presence, along with Wilmington’s proximity to
the Research Triangle Park, has helped the area attract other major CROs and to spawn
entrepreneurial startups. Of the 25 CROs represented in the region, 3 have headquarters here.
A multitude of additional local companies provide specific support to CROs in the area (more
than 40 support companies), and the University of North Carolina Wilmington offers educational
programs to support the industry’s workforce development needs. According to the Bureau of
Labor Statistics, annual income of the over 2,500 local clinical research employees averaged
$82,578 in 2012. Local healthcare providers already conduct clinical trials, often managed by
CROs, but ample opportunity exists to increase the number of clinical trials conducted locally.
The purpose of this report is to provide an industry snapshot to illustrate the impact of the
clinical research industry on the area and to identify ways in which the cluster can grow. This
report specifically addresses a three-county focus area that includes Brunswick, New Hanover,
and Pender counties— formally known as the Wilmington Metropolitan Statistical Area. To
determine what action steps are needed to enhance the local clinical research cluster, information
pertinent to the clinical research industry has been compiled in this report. From this information,
general conclusions are made with specific recommendations about how the number of local
clinical trials can be increased and the local cluster of companies can grow.
Open Clinical Research Studies in Wilmington
In April 2014, there were 21,231 open clinical studies in the United States, 2,293 or 10.8% of
which have an investigative site in North Carolina (ClinicalTrials.gov). Wilmington, NC was
host to 109 open clinical studies. Of those studies, 13 were observational registries managed by
companies, such as INC Research, located in Wilmington. As seen in Table 1: Clinical Trial
Phases, the studies conducted in Wilmington range from phases I- IV. The focus of the studies in
Wilmington varies widely; however, a large number of studies focus on cancer, arthritis,
diabetes, and COPD, as seen in Table 2: Clinical Trial Focus Areas. Of the 20 cancer studies
conducted in our area, 16 trials were funded by the National Institutes of Health (NIH).
Table 1: Clinical Trial Phases
Phase
Number of
Studies
Phase I
1
Phase II
14
Phase III
56
Phase IV
19
Table 2: Clinical Trial Focus Areas
Focus
Number of
Studies
Cancer
20
Diabetes
15
Arthritis
10
COPD
8
Source: ClinicalTrials.gov
04/21/2014
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Number of Clinical Trials Conducted in Areas Similar in Size to Wilmington
Wilmington is well-positioned to increase the number of clinical trials conducted locally. Table
3: Comparison of Clinical Trials by City shows that, while the New Hanover County population
is only slightly lower than in Buncombe County, the Wilmington area hosts significantly fewer
trials than the Asheville area. A range of actions can increase the number of local clinical trials.
Table 3: Comparison of Clinical Trials by City
City/County
Durham/Durham
Chapel Hill/Orange
Winston-Salem/Forsyth
Charlotte/Mecklenburg
Raleigh/Wake
Asheville/Buncombe
Greensboro/Guilford
Greenville/Pitt
Wilmington, NC/New Hanover
High Point/Guilford
Cary/Wake
Fayetteville/Cumberland
Number of
Clinical Trials
2011
County Population
2011 Physicians per 10,000
(County Level)
899
544
524
468
205
153
130
114
109
57
33
16
272,314
135,776
354,878
940,697
925,938
243,855
495,231
170,263
206,774
495,231
925,938
327,643
74.7
94.4
47.0
27.7
23.8
35.4
24.3
45.4
32.4
24.3
23.8
16.6
Source: ClinicalTrials.gov, NC OSBM, & Cecil G. Sheps Center for Health Services Research
Firms Recruiting Patients for Clinical Trials
Several companies in Wilmington are devoted to clinical trial enrollment, including PMG
Research and Trial Management Associates. These firms actively recruit patients in the
Wilmington area to participate in a variety of observational and interventional clinical trials.
Trial Management Associates has three focus areas—nephrology, gastroenterology, and
dermatology. PMG Research works with clinical trials in a wider variety of therapeutic areas.
Physicians and Medical Practices Engaging in Clinical Trials
Over 19 medical practices in Wilmington have participated in at least 1 clinical trial (see contact
information in Appendix 1: Medical Practices Engaging in Clinical Research). Wilmington also
has more than 40 physicians conducting clinical trials. The focus areas of these clinical trials
include arthritis, cancer, cardiology, dermatology, gastroenterology, internal medicine,
nephrology, neurology, otolaryngology, psychiatry, pulmonology, and urology. In Wilmington,
45 clinical trials identify the medical groups participating in a particular clinical trial. A list of
specific trials and the medical groups associated with each trial is listed in Appendix 2: Medical
Practices Associated with Specific Clinical Trials. The list of practices engaging in clinical trials
is based upon the most currently available data and is not complete, because many practices and
studies choose not to release trial information to the general public.
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Health Professional Data
Table 4: Health Professional Data by County lists the number and focus area of doctors
available in the 3-county focus area, in 2010. An important statistic to note is the number of
physicians per 10,000 residents. North Carolina has an average of 22.1 physicians per 10,000
residents and a rate of 7.8 primary care physicians per 10,000 residents. New Hanover County
well exceeds the state average (32.2 per 10,000 residents) and is ranked in the top 10 counties in
the state in both areas. Appendix 3: Health Professional Data for Selected NC Counties
combines the data seen in Table 3 and Table 4 to illustrate the connection between the number of
physicians and clinical trials being conducted. Based upon that data seen in Appendix 3, the
presence of a greater number of physicians per 10,000 residents often results in a greater number
of clinical trials. Upon request, additional information regarding the number of specialists in
specific areas is available.
Table 4: Health Professional Data by County
New
Hanover
County
Brunswick
County
Pender
County
206,774
110,312
53,466
247
62
3
100
39
43
395
10
652
59
26
1
0
16
9
8
0
121
18
10
2
5
0
1
7
0
25
32.2
11
4.8
6
10.1
54
5.4
87
3.9
9
58
88
Pharmacists
Registered Nurses
Nurse Practitioners
240
2,864
130
81
534
29
23
191
14
General Hospital Beds 2014
Hospital Discharges 2011
647
21,055
110
12,012
43
5,697
2011 County Population
Primary Care Physicians
(* included in primary care physicians total)
otal)Family Practice*
General Practice*
Internal Medicine*
Obstetrics/Gynecology*
Pediatrics*
Other Specialties
Federal Physicians
Total Physicians
Physicians per 10,000 Population
Number of Physicians: State Rank (1=most physicians)
Primary Care Physicians per 10,000 Population
Number of Primary Care Physicians: State Rank (1=most
physicians)
p
Source: Cecil G. Sheps Center for Health Services Research
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Contract and Clinical Research Organizations
Wilmington is home to PPD Worldwide Corporate Headquarters, and a host of other large and
small CROs operate in the city and region. Many of these companies continue to grow and
develop in the Wilmington area. Currently, there are 25 CROs in the region with a total
employment of more than 2,500. Additionally, the Wilmington area is home to at least 40
clinical research support companies, employing more than 200 individuals.
Clinical research support companies provide very specialized services, such as biostatistics,
clinical trial data management, laboratory testing services, medical writing, and patient
recruitment to support other companies. The region is also home to at least 13 drug, medical
device, and testing development companies, employing more than 50 individuals. These
companies range in size from large, multi-national companies to small entrepreneurial ventures.
Below is a list of the CROs and clinical trial support companies that are either headquartered in
or have a presence in the Wilmington area, which includes New Hanover, Pender, and
Brunswick Counties. Appendix 5: Contact Research Organization Contact Information provides
each company’s contact information, as well as a synopsis of activities. Appendix 6: Clinical
Research Support Company Contact Information provides each company’s contact information
focus areas. Appendix 7: Drug, Medical Device, & Testing Development Company Contact
Information lists the companies that develop pharmaceuticals, medical devices, and testing.
Contract Research Organizations
AAIPharma (HQ)
Blitz Research
Catalent
Chiltern International
Clinipace Worldwide
Covance
The EMMES Corporation
ICON
INC Research
inVentiv Health
Jubilant Clinsys
Modoc Research (HQ)
Novella Clinical
04/21/2014
OrphanReach
PAREXEL International
Perficient
Pharm-Olam International
PPD (HQ)
PRA International
Premier Research
Quintiles
Research Pharmaceutical Services
Sarah Cannon Research Institute
SynteractHCR
Theorem Clinical Research
Worldwide Clinical Trial
4|Page
Clinical Trial Collaborators and Support Companies
Biostatistics
Biostudy Solutions (HQ)
PharPoint Research
Triangle Biostatistics, LLC
Clinical Trials Data Management
Clinical Ink
OptumInsight
SAS
Clinical Trial Insurance
Arthur J. Gallagher Risk Management Services
Aquesta Insurance Services
HR Support
Babb McGrew (HQ)
Hawthorne Search (HQ)
Human Capital Solutions (HQ)
Thinkingahead
Independent Consultants
Amanda Grim's GCP Audits (HQ)
Argent Rx Solutions (HQ)
BioClin Consulting (HQ)
Biopharmaceutech International (HQ)
Cape Fear Research Consultants (HQ)
Coastal Pharmaceutical Consultants (HQ)
DMS Clinical Research Services (HQ)
Hashimoto Consulting Services (HQ)
Hermes (HQ)
KButler GxP Consulting (HQ)
MSS Pharmaceutical Consulting (HQ)
Navigator Life Science Advisory (HQ)
Outsourcing Support Services, Inc (HQ)
Pharmalogx (HQ)
Rothermel Clinical Research Consulting (HQ)
Spataro & Associates (HQ)
Wagoner Consulting (HQ)
Information Technology
Bluewater Technology Partners (HQ)
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Clinical Trial Collaborators and Support Companies (continued)
Laboratory Testing Services
Eurofins Scientific
Quality Chemical Laboratories (HQ)
Solstas Lab Partners
Wilmington Pathology Associates (HQ)
Marketing
A. Revell Communications (HQ)
Bon's Eye Marketing (HQ)
Medical Writing
Modoc Research (HQ)
Regulatory Writing Solutions (HQ)
Patient Recruitment
ClinEdge
Endeavour Clinical Solutions
MediciGlobal Inc
PMG Research
Trial Management Associates (HQ)
Pharmaceutical Sales Training
Proficient Learning (HQ)
Drug, Medical Device, & Testing Development
Drug Development
Alvogen
CardioPharma (HQ)
Furiex Pharmaceuticals
Leonard Consulting (HQ)
MARBIONC Development Group (HQ)
Osmotica Pharmaceutical (N.A. HQ)
Wilmington Pharmaceuticals (HQ)
Medical Device Development & Testing
Baxano Surgical
Cortech Solutions (HQ)
OrthoKinetic Technologies (HQ)
MindSkid Labs (HQ)
Testing Development & Manufacturing
AccuGenomics (HQ)
MicroGuard Consulting (HQ)
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Regional Demographics
The Wilmington area has a unique demographic composition. One important inclusion criteria
considered in the clinical trials industry is age. In general, the age distribution within the threecounty focus area mimics national and state trends. However, New Hanover County has a largerthan-usual population of individuals ranging in age from 20-29 years old (see Table 5:
Percentage of Young Adults in Southeastern NC). Brunswick County exhibits a similar trend
among individuals over the age of 54 (see Table 6: Percentage of 55+ in Southeastern NC).
Race and ethnicity may also be considered an inclusion factor in many clinical trials. None of the
counties in the focus area have a racial composition that is similar to the state of North Carolina,
as the representation of African Americans and Hispanics are lower than the state average.
However, New Hanover County has similar race and ethnicity demographics to the United States
(see Table7: Ethnic Composition).
Table 6: Percentage of 55+ in
Southeastern NC
Table 5: Percentage of Young
Adults in Southeastern NC
10%
US
NC
Brunswick
New Hanover
8.80%
4.50%
5.30%
4%
4.20%
2.00%
0%
10%
25 to 29 years
4.00%
5.90%
6.80%
20 to 24 years
6.00%
5.40%
5.60%
2%
8.00%
6.40%
6.30%
8.10%
6.50%
7.10%
4%
6.80%
6.60%
5.20%
7.90%
5.40%
6%
10.00%
7%
6.90%
4.40%
9.10%
5.30%
8%
0.00%
US
Pender
55 to 59 years 60 to 64 years 65 to 69 years
NC Brunswick New Hanover Pender
Source: 2012 US Census ACS 5-Year Estimates
Source: 2012 US Census ACS 5-Year Estimates
Table 7: Ethnic Composition
100.00%
6.06%
5.15%
5.01%
8.34%
16.35%
18.37%
14.64%
11.24%
21.45%
12.56%
76.29%
80.45%
20.00%
69.78%
40.00%
74.17%
60.00%
84.56%
80.00%
0.00%
White alone
United States
North Carolina
Black or African
American alone
Brunswick
Hispanic or Latino
New Hanover
Pender
Source: 2012 US Census ACS 5-Year Estimates
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Regional Health Data
Health data can be useful when evaluating where to locate investigational sites. Areas with a
higher prevalence of certain types of medical conditions are ideal for clinical trials aimed at
treating those conditions. The higher rate can help to ensure that a larger number of potential
participants for a study that meet the inclusion criteria are available.
Appendix 4: Regional Health Statistics includes a number of health statistics from across
Southeastern North Carolina. A broader approach to collecting this data was taken for several
reasons. One consideration is that patients may already travel to Wilmington to receive treatment
for certain healthcare issues and could easily participate in clinical trials being offered in the focus
area. Another reason for including regional health statistics is that New Hanover Regional Medical
Center has locations throughout the area. Additionally, doctors who have offices in both
Wilmington and the rural counties could identify candidates from those areas, as well.
Some highlights identified in Appendix 4: Regional Health Statistics include the large percentages
of the population with diabetes living in the region. Of the 12 counties included in this data set,
only Onslow and Brunswick counties have diabetes occurrence rates lower than the state average.
Additionally, a relatively large number of individuals are classified as being obese. 9 of the
12 counties have a higher percentage of individuals who are considered obese (defined as BMI
greater than or equal to 30) than the state average. Most notable are the obesity rates in Duplin and
Robeson counties where 40% of the population is considered obese. It is important to note that
obesity is linked to a range of other health issues according to the Center of Disease Control. These
issues include heart disease, stroke, type 2 diabetes, cancers, hypertension, high cholesterol, liver
disease, gallbladder disease, sleep apnea, respiratory problems, and osteoarthritis.
New Hanover County also has a rate more than double the state average of persons being served at
alcohol and drug treatment centers. Consequently, the location may serve as an exceptional
location to evaluate medical advances for treating individuals with these types of addictions.
Cardiovascular disease is another prominent medical condition in the region. From 2003 to 2007,
Columbus, Robeson, Sampson and Scotland counties have had a larger proportion of residents
hospitalized for medical conditions related to cardiovascular diseases, when compared to the state
average. One of the most striking features related to cardiovascular medical conditions is the 5year hospitalization rates for strokes in 8 of the 12 counties, which are above the state average.
In general, the region appears to have average incidence rates in terms of the number of cancer
cases. However, there are some counties with cancer rates that are above average. For example,
Onslow County has a substantially higher rate of individuals with lung cancer. The region also has
a large number of hospitalizations due to septicemia, which may make the area a prime location to
test new medical advances aimed at treating the illness.
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Recommendations
Building Community Cohesion: The North Carolina Coast Clinical Research Initiative
(NCCCRI) should continue working with CROs, UNCW, doctors, clinical trial patient
recruitment companies, and other local business and community leaders to host networking
opportunities and educational programs that strengthen the existing local cluster of companies
(Current activity of the Events Team includes the Leadership Networking Series, the Lunch-andLearn Series and the Dinner Talk events, in addition to other targeted educational events and
focus groups). Additionally, the NCCCRI should continue working with companies and
education leaders to create educational programs, including internships, that develop the clinical
research industry workforce (e.g., the BioStats Team focused on enhancing the statistics program
and internship opportunities at UNCW).
Promoting the Local Clinical Research Industry Cluster: The NCCCRI should continue to work
with CR companies, economic developers, and others to raise awareness about and promote the
local CR industry cluster in the region and beyond. In addition to local promotions, the NCCCRI
Communications Team should develop and implement a large-scale marketing campaign to
attract additional talent, companies, and clinical trials to the area. One component of this strategy
is to represent the local CR industry cluster at events, such as the annual BIO International
Conference as part of the N.C. Pavilion, and to target specific companies for recruitment.
Increasing Local Clinical Trials: The NCCCRI should continue working with doctors, clinical
trial patient recruitment companies, and CROs to recruit additional clinical trials to the area.
When the health data is considered, along with the focus area and number of clinical trials,
Wilmington could easily support additional clinical trials. Table 3: Comparison of Clinical
Trials by City illustrates that areas slightly larger than New Hanover County, such as Buncombe
County, support many more clinical trials than does Wilmington. The number of trials supported
by a region is related more to the total number of available investigators than the size of its
population. For instance, Asheville’s and Buncombe County’s medical centers include a greater
number of physicians involved in research. The age of the population is another factor more
important than the total population when considering a region’s capacity to host clinical trials.
One potential way to increase the number of clinical trials in the Wilmington area is to establish
a greater focus on clinical research at the regional medical center. For example, Mission Hospital
in Asheville has established a Research Institute to attract and host clinical trials. Similarly, East
Carolina University’s Brody School of Medicine in Greenville has established a clinical trials
working group. While New Hanover Regional Medical Center (NHRMC), Wilmington’s
primary hospital facility, does offer clinical trials through the Zimmer Cancer Center in
conjunction with the University of North Carolina at Chapel Hill, NHRMC does not appear to
offer clinical trials in any other therapeutic areas currently.
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Recommendations (cont.)
Additional clinical trials should be targeted to match the specific medical conditions in the region
in which there is higher prevalence, to increase the likelihood of obtaining the optimal number of
patients. These medical conditions include the following: diabetes, obesity, alcohol and drug
addiction, HIV and AIDS, septicemia, heart disease, and stroke. NCCCRI should target doctors
who work in those specialty areas to gauge their interest in participating in clinical trials. The
data from this report should be used to validate why doctors in those specific fields are being
targeted to conduct trials and why ample opportunity exists to increase clinical trial enrollments.
Clinical trials that have inclusion criteria related to requiring participation from patients aged 2029 or aged 55 and over should also be targeted. As Tables 5 indicates, New Hanover County has
a significantly larger percentage of 20-29 year olds. Table 6, displays the advantages Brunswick
County offers in terms of being able to produce clinical trial candidates over the age of 55. An
additional benefit of the region is that the racial and ethnic composition mirrors the United
States. Patient recruitment companies, such as Inclinix-PMG Research and Trial Management
Associates, should be directly involved with attracting additional studies and recruiting
additional physicians to participate in the trials, as well.
Conclusion
The Southeastern Region is home to a strong cluster of companies working in and supporting the
clinical research industry with a full range of services, as well as educational support from
UNCW and promotional support from local economic development leaders. Despite this worldclass clinical research cluster, the Wilmington area lags in the number of clinical trials being
conducted locally. This report has outlined several strategies to increase the number of clinical
trials conducted in the southeastern region, including targeting trials that focus on specific health
issues that are prevalent in the greater Wilmington area. The NCCCRI should continue its work
to increase the awareness and number of clinical trials in the area, to host events that connect the
members of the clinical research community, and to work with key partners in a variety of other
ways to strengthen the impressive clinical research cluster in the southeastern region.
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Report Notes
Data Sources and Methodology
Data used in this report was gathered from variety of sources, including governmental and
educational institutions. Information related to the number and types of clinical trials being
conducted in the area was gathered from ClinicalTrials.gov. Data regarding the medical practices
engaged in clinical trials and the trials being conducted at each practice was compiled from
CenterWatch.com and ClinicalTrials.gov. The Cecil G. Sheps Center for Health Services
Research, supported by UNC – Chapel Hill, served as the source for the number of health
professionals, hospital beds, and discharges. Demographic information was acquired from the 5Year American Community Survey, conducted by the US Census Bureau, and the NC Office of
State Budget and Management. Health data was gathered from the North Carolina Health Data
Explorer, supported by East Carolina University. Information and statistics related to the number
and types of companies in the area was gathered from LinkedIn and through surveys of each
company’s website.
Report Rationale
In many cases the North American Industry Classification System (NAICS) can be used to
estimate the impact a particular industry has on a local economy. However, the local clinical
research cluster is multi-disciplinary, and NAICS does not accurately capture the industry
cluster’s impact. The most commonly used NAICS code for clinical research is 541711 research and development in biotechnology. In 2012, the US Bureau of Labor Statistics
Quarterly Census of Employment and Wages estimated 1,895 individuals in the Wilmington area
were classified as NAICS 541711 employees and combined to earn an average salary of $82,578.
While NAICS 541711 captures many employees of the clinical research industry, it does not
include important components such as health services, biostatistics, and patient recruitment. The
purpose of the Report on the Clinical Research Industry Cluster in Southeastern NC is to
examine local employment data in a deeper, more comprehensive way to provide a more
accurate illustration of the local cluster, in a way that NAICS codes do not allow.
Acknowledgement
Thank you to Emmit Owens for his significant contribution to the creation and updates of this
report.
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Appendix 1: Medical Practices Engaged in Clinical Research
Medical Practice Name
Address
City
Atlantic Dermatology Associates, P.A.
1099 Medical Center Dr. #201
Carolina Dermatology & Skin Cancer
Surgery
Knox Clinic Pediatrics, PLLC
Phone Number
Wilmington NC
Zip
Code
28401
1814 Glen Meade Road
Wilmington NC
28403
(910) 254.3544
2304 Delaney Avenue
Wilmington NC
28403
(910) 763-3349
New Hanover Regional Medical Center Zimmer Cancer Center
New Hanover Regional Medical Center Betty Cameron Women & Children's
Hospital
Wilmington Gastroenterology Associates
2131 S. 17th Street
Wilmington NC
28403
(910) 343.7000
2131 S. 17th Street
Wilmington NC
28403
(910) 343.7000
5115 Oleander Drive
Wilmington NC
28403
(910) 362-1011
Wilmington Health, PLLC
1202 Medical Center Dr.
Wilmington NC
28401
(910) 343-9991
Coastal Carolina Radiation Oncology
1988 S 16th S
Wilmington NC
28401
(910) 251-1839
New Hanover Medical Group PA
1960 S 16th Street
Wilmington NC
28401
(910) 343-9991
Carolina Arthritis Associates
1710 South 17th Street
Wilmington NC
28401
(910) 762-1182
Wilmington Psychiatric Associates
2311 Canterwood Dr.
Wilmington NC
28401
(910) 362-1010
UNC Wilmington, Department of
Psychology
600 S. College Rd.
Wilmington NC
28403
(910) 962-3000
04/21/2014
State
(910) 251-9944
Appendix 1
Dermatology Associates, P.A.
6781 Parker Farm Road, Suite 300
Wilmington NC
28405
(910) 763-1555
Cape Fear Heart Associates
1725 New Hanover Medical Park Dr. Wilmington NC
28403
(910) 815-3420
Coastal Urology, PLLC
1099 Medical Center Dr, Ste 101
Wilmington NC
28401
(910) 254-9995
Coastal Surgery
1411 Physicians Dr.
Wilmington NC
28401
(910) 343-0811
University Physicians
2221 S. 17th St.
Wilmington NC
28401
(910) 815-5081
INC Research (call centers)
1011 Ashes Dr.
Wilmington NC
28405
(910) 341-3300
Source: CenterWatch & ClinicalTrials.gov
04/21/2014
Appendix 1
Appendix 2: Medical Practices Associated with Specific Clinical Trials
Specific Study
Phase
Medical Practice
Focus
Study to Evaluate the Efficacy and Safety of M518101 in
Subjects With Plaque Psoriasis
Oropharyngeal Administration of Mother's Colostrum for
Premature Infants
Phase
3
N/A
Atlantic Dermatology
Associates
Betty Cameron Women &
Children's Hospital
Psoriasis
N/A
Phase
3
Carolina Arthritis
Associates, PA
Carolina Arthritis
Associates, PA
Carolina Arthritis
Associates, PA
Carolina Arthritis
Associates, PA
Coastal Carolina Radiation
Oncology
Coastal Carolina Radiation
Oncology
Phase
3
Phase
3
Coastal Carolina Radiation
Oncology Center
Coastal Carolina Radiation
Oncology Center
Cancer
Phase
2
Phase
3
Phase
2|Phase
3
Coastal Carolina Radiation
Oncology Center
Coastal Carolina Radiation
Oncology Center
Coastal Surgery Specialists
Caner
Observational Study of the Use of KRYSTEXXA® in
Refractory Chronic Gout
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate
Response to TNF Inhibitors
Dose-finding Study of GLPG0634 as Monotherapy in Active
Rheumatoid Arthritis (RA) Patients (DARWIN2)
Dose-finding Study of GLPG0634 as add-on to Methotrexate
in Active Rheumatoid Arthritis Patients (DARWIN1)
Cardiovascular Risk and Preventive Care in Prostate Cancer
Patients Receiving Radiation and Hormone Therapy
Standard or Comprehensive Radiation Therapy in Treating
Patients With Early-Stage Breast Cancer Previously Treated
With Chemotherapy and Surgery
Stereotactic Radiation Therapy With or Without Whole-Brain
Radiation Therapy in Treating Patients With Brain Metastases
Three Different Radiation Therapy Regimens in Treating
Patients With Limited-Stage Small Cell Lung Cancer
Receiving Cisplatin and Etoposide
Stereotactic Body Radiation Therapy (SBRT) in Metastatic
Non-small Cell Lung Cancer
Androgen-Deprivation Therapy and Radiation Therapy in
Treating Patients With Prostate Cancer
Randomized Study of Laser and Balloon Angioplasty Versus
Balloon Angioplasty to Treat Peripheral In-stent Restenosis
04/21/2014
Phase
3
Phase
2
Phase
2
N/A
Infection|Enterocolitis,
Necrotizing|Ventilatorassociated Pneumonia
Chronic Gout
Psoriatic Arthritis
Rheumatoid Arthritis
Rheumatoid Arthritis
Prostate Cancer
Breast Cancer
Lung Cancer
Prostate Cancer
Peripheral Arterial
Disease
Appendix 2
An Evaluation of Neurofeedback Efficacy in Adults With
ADHD
A Long Term Study To Evaluate The Safety And Tolerability
Of CP-690,550 For Patients With Moderate To Severe Chronic
Plaque Psoriasis
Adenovirus Vaccine Pregnancy Registry
Phase
3
A Global Imatinib and Nilotinib Pregnancy Exposure Registry
Ribavirin Pregnancy Registry
Exenatide Pregnancy Registry - Type 2 Diabetes in Pregnancy
An Observational Study of Pregnancy And Pregnancy
Outcomes in Women With Breast Cancer Treated With
Herceptin, Perjeta In Combination With Herceptin, or Kadcyla
During Pregnancy or Within 6 Months Prior To Conception
(MotHER)
The Savella Pregnancy Registry
A Prospective, Observational Study of Pregnancy Outcomes
Among Women Exposed to Truvada for PrEP Indication
The Cymbalta Pregnancy Registry
N/A
ADHD
N/A
Department of Psychology,
UNC Wilmington
Dermatology Associates;
New Hanover Medical
Research Associates
INC Research
N/A
INC Research
Phase
4
Phase
4
Phase
4
INC Research
Glivec/Gleevec and
Tasigna
Birth Defects
INC Research
Birth Defects
INC Research
Breast Cancer &
Pregnancy
N/A
INC Research
Fibromyalgia
N/A
INC Research
HIV Infection
N/A
INC Research
Pregnancy
Psoriasis
Breast Cancer
Evaluate the Efficacy and Safety of M518101 in Subjects With
Plaque Psoriasis
New Biomarkers Evaluating Ovarian Cancer
Phase
3
N/A
Higher Per Daily Treatment-Dose Radiation Therapy or
Standard Per Daily Treatment Radiation Therapy in Treating
Patients With Early-Stage Breast Cancer That Was Removed
by Surgery
Early Surgery or Standard Palliative Therapy in Treating
Patients With Stage IV Breast Cancer
Phase
3
Medical Development
Center
New Hanover Regional
Medical Center
New Hanover Regional
Medical Center
Phase
3
New Hanover Regional
Medical Center
04/21/2014
Psoriasis
Adenovirus
Adnexal Mass
Breast Cancer
Appendix 2
Cisplatin and Radiation Therapy With or Without Carboplatin
and Paclitaxel in Patients With Locally Advanced Cervical
Cancer
Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or
Without Celecoxib in Treating Patients With Stage III Colon
Cancer Previously Treated With Surgery
Pelvic Radiation Therapy or Vaginal Implant Radiation
Therapy, Paclitaxel, and Carboplatin in Treating Patients With
High-Risk Stage I or Stage II Endometrial Cancer
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane
With or Without Chemotherapy in Treating Patients With
Invasive RxPONDER Breast Cancer
S0819: Carboplatin/Paclitaxel With or Without Bevacizumab
and/or Cetuximab in Stage IV or Recurrent Non-Small Cell
Lung Cancer
Cabozantinib or Paclitaxel in Treating Patients With Persistent
or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary
Peritoneal Cavity Cancer
Cosmetic Evaluation of Lumpectomy Versus Oncolytic
Mammoplasty With Bilateral Breast Reduction for Early Stage
Breast Cancer
Phase
3
New Hanover Regional
Medical Center
Cancer
Phase
3
New Hanover Regional
Medical Center
Colorectal Cancer
Phase
3
New Hanover Regional
Medical Center
Phase
3
New Hanover Regional
Medical Center
Endometrial Cancer,
Fatigue, &
Neurotoxicity
Cancer
Phase
3
New Hanover Regional
Medical Center
Lung Cancer
Phase
2
New Hanover Regional
Medical Center
Cancer
N/A
Breast Carcinoma
Prostate Radiation Therapy or Short-Term Androgen
Deprivation Therapy and Pelvic Lymph Node Radiation
Therapy With or Without Prostate Radiation Therapy in
Treating Patients With a Rising Prostate Specific Antigen
(PSA) After Surgery for Prostate Cancer
Radiation Therapy With or Without Androgen-Deprivation
Therapy in Treating Patients With Prostate Cancer
Phase
3
New Hanover Regional
Medical Center; Coastal
Carolina Radiation
Oncology Center
New Hanover Regional
Medical Center; Coastal
Carolina Radiation
Oncology Center
New Hanover Regional
Medical Center; Coastal
Carolina Radiation
Oncology Center
PDD and GSK Call
Prostate Cancer
Belimumab (BENLYSTA®) Pregnancy Registry
04/21/2014
Phase
3
N/A
Prostate Cancer
Systemic Lupus
Erythematosus
Appendix 2
12-Week Study of Plecanatide for CIC (The CIC3 Study)
Open-label Extension (OLE) Study of Plecanatide for Chronic
Idiopathic Constipation (CIC)
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate
Safety of 0.03% DSC127 Topical Gel in Chronic Use
A Prospective, Randomized, Double-Blind Multicenter Study
Comparing Continuous Diffusion of Oxygen (CDO) Therapy
to Standard Moist Wound Therapy (MWT) in the Treatment of
Diabetic Foot Ulcers
Phase III Study to Evaluate Efficacy and Safety of DSC127 in
Diabetic Foot Ulcers
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic
Subjects
Long Term Study to Evaluate Safety and Efficacy of M518101
in Subjects With Plaque Psoriasis
Safety and Efficacy Study of IPX159 in Restless Legs
Syndrome (RLS)
Study to Characterize the Pharmacokinetics of a Single Dose
of SC Abatacept 125 mg Using the BD Autoinjector or the
Prefilled Syringe
Smoking Cessation Study In Healthy Adolescent Smokers
International Hernia Mesh Registry
Phase
3
Phase
3
Phase
3
N/A
PMG Research
PMG Research
Chronic Idiopathic
Constipation
Chronic Idiopathic
Constipation
Diabetic Foot Ulcer
PMG Research
Diabetic Foot Ulcer
Phase
3
Phase
2
Phase
3
Phase
2
Phase
1
PMG Research
Diabetic Foot Ulcers
PMG Research
Dyslipidemia
PMG Research
Psoriasis
PMG Research
PMG Research
Restless Legs
Syndrome
Rheumatoid Arthritis
Phase
4
N/A
PMG Research
Smoking Cessation
University Physicians
Hernia
Ventral
Hernia|Incisional
Hernia
Hepatitis C
PMG Research
A Prospective, Multi-Center Study of Phasixâ„¢ Mesh for
Ventral or Incisional Hernia Repair.
N/A
University Physicians
HCV-TARGET- Hepatitis C Therapeutic Registry and
Research Network
Apnex Clinical Study of the Hypoglossal Nerve Stimulation
(HGNS®) System to Treat Obstructive Sleep Apnea
N/A
Trial Management
Associates
Wilmington Medical
Research
N/A
Obstructive Sleep
Apnea
Source: ClinicalTrials.gov & CenterWatch
04/21/2014
Appendix 2
Appendix 3: Health Professional Data for Selected NC Counties*
Number of Clinical Trials
Largest Cities
2011 County Populations
Primary Care Physicians
(* included in primary care physicians total)
Family Practice*
New Hanover
County
Durham
County
Forsyth
County
Mecklenburg
County
Orange
County
Wake
County
Guilford
County
Buncombe
County
Pitt
County
Cabarrus
County
Cumberland
County
101
793
511
507
503
223
205
163
105
33
19
Wilmington
Durham
WinstonSalem
Charlotte
Chapel
Hill
Raleigh,
Cary
Greensboro,
High Point
Asheville
Greenville
Concord
Fayetteville
206,774
272,314
135,776
354,878
940,697
925,938
243,855
495,231
170,263
327,643
206,774
209
442
322
452
890
807
290
425
235
193
209
61
81
99
127
232
235
124
144
65
66
61
General Practice*
2
3
1
2
3
6
3
1
3
1
2
Internal Medicine*
79
205
113
187
314
246
86
137
88
60
79
Obstetrics/Gynecology*
30
52
38
39
132
102
40
61
29
26
30
Pediatrics*
37
101
71
97
209
218
37
82
50
40
37
Other Specialties
460
1592
960
1216
1717
1401
573
780
538
351
460
Federal Physicians
12
154
13
36
35
22
77
3
15
203
12
Total Physicians
669
2034
1282
1668
2607
2208
863
1205
773
544
669
Physicians per 10,000 Population
32.4
74.7
94.4
47.0
27.7
23.8
35.4
24.3
45.4
16.6
32.4
6
2
1
3
8
13
5
12
4
32
6
10.1
16.2
23.7
12.7
9.5
8.7
11.9
8.6
13.8
5.9
10.1
9
2
1
5
12
18
7
19
3
49
9
Pharmacists
240
640
308
522
1004
1124
328
465
203
233
240
Registered Nurses
2864
6418
3388
6567
10923
9726
4307
5878
3487
2895
2864
Nurse Practitioners
130
371
198
250
455
377
168
230
149
112
130
General Hospital Beds 2010
647
1,302
724
1,689
2,192
1,362
735
1,068
734
556
647
21,055
27,502
10,900
43,305
87,817
80,658
24,931
57,726
19,347
33,785
21,055
Number of Physicians: State Rank (1=most physicians)
Primary Care Physicians per 10,000 Population
Number of Primary Care Physicians: State Rank
(1=most physicians)
Hospital Discharges 2009
*Sorted by number of clinical trials
04/21/2014
Source: US Census, ClinicalTrials.gov, & Cecil G. Sheps Center for Health Services Research
Appendix 3
Appendix 4: Regional Health Statistics
The health data used in this appendix was gathered from a variety of sources listed below each chart. Additionally, a
short explanation of the data is provided beneath each chart.
Percentage of Adult Population with Diabetes (2005-2009)
18%
16.3%
16%
14.3%
13.1%
14%
12%
10%
10.8%
9.0%
10.7%
8.8%
8.8%
10.8% 10.6% 10.3%
11.5%
8.3%
8%
6%
4%
2%
0%
Source: North Carolina Health Data Explorer
The percentage of the adult population with diabetes is calculated by dividing the estimated number of adults with
diabetes by the total population.
45%
40%
Percentage of Adult Population Considered Obese*
(2005-2009)
39.78%
32.66%
31.74%
31.54%
27.72%
30% 28.20%
35%
25%
39.56%
31.29%
33.17%
36.86%
34.33%
27.89%
24.89%
20%
15%
10%
5%
0%
Source: North Carolina Health Data Explorer
*Defined as BMI greater than or equal to 30
The percentage of the adult population considered obese is calculated by dividing the estimated number of adults
considered obese by the total population.
04/21/2014
Appendix 4
Percentage of Population with HIV & AIDS (2010)
0.40%
0.36%
0.35%
0.30%
0.26%
0.25%
0.29%
0.28%
0.25%
0.31%
0.29%
0.28%
0.23%
0.21%
0.20%
0.13%
0.15%
0.10%
0.05%
0.11%
0.12% 0.13%
0.13%
0.15%
0.10% 0.12%
0.07%
0.12% 0.12%
0.14%
0.10%
0.12%
0.05% 0.06%
0.00%
HIV Disease Cases Living as of 2010
AIDS Disease Cases Living as of 2010
Source: North Carolina Health Data Explorer
The percentage of population with HIV or AIDS is calculated by dividing the number of individuals living with HIV
or AIDS by the total population of each county.
Percentage of Persons Served at State Alcohol and Drug
Treatment Centers (2009-2010)
0.14%
0.11%
0.12%
0.10%
0.08%
0.08%
0.06%
0.04%
0.02%
0.05%
0.07%
0.06%
0.05% 0.04%
0.04%
0.01%
0.02%
0.03%
0.03%
0.02%
0.00%
Source: North Carolina Health Data Explorer
The percentage of persons served at state alcohol and drug treatment centers is calculated by the number of
individuals treated at state alcohol and drug treatment centers by the total population of each county.
04/21/2014
Appendix 4
Average Annual Number of Cardiovascular Disease Hospitalizations
per 100,000 (2003-2007)
3500
3013
3000
2714
2500
2000
2249
3026
2121
1948
1738
2843
1766
1523
1399
1500
1199
1045
1000
500
0
Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census
Cardiovascular disease includes all diseases of the heart or blood vessels. The hospitalizations during the 5-year
period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same individual.
Average Annual Number of Heart Disease Hospitalizations per 100,000
(2003-2007)
2500
2,198
2000
1,776
1,533
1500
2,089 2,074
1,196
1000
1,483
1,314
1,009
922
1,164
845
678
500
0
Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census
Heart disease is limited to diseases of the heart. The hospitalizations during the 5-year period are averaged and
calculated on a per 100,000 basis. May include multiple visits by the same individual.
04/21/2014
Appendix 4
Average Annual Number of Coronary Heart Disease Hospitalizations
per 100,000 (2003-2007)
1,163
1200
1,003
1000
800
600
733
693
594
556
520
938
380
400
373
399
426
276
200
0
Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census
Coronary heart disease is due to the narrowing of blood vessels that supply blood to the heart. The hospitalizations
during the 5 year period are averaged and calculated on a per 100,000 basis. May include multiple visits by the same
individual.
Average Annual Number of Stroke Hospitalizations per 100,000
(2003-2007)
500
451
400
300
449
395
293
200
395
345
331
396
324
269
253
195
180
100
0
Source: Start with Your Heart, Justus-Warren Heart Disease and Stroke Prevention Task Force; 2010 US Census
Stroke is the sudden loss of consciousness due to a rupture or occlusion of blood vessels that lead to the brain. The
hospitalizations during the 5 year period are averaged and calculated on a per 100,000 basis. May include multiple
visits by the same individual.
04/21/2014
Appendix 4
Cancer Incidence Rate per 100,000 (2005-2009)
700
600
577.8
543
500.1
500
472.2
497.8
442
436.4
402.7 418.9
511.2
491
422.8
385.8
400
300
200
100
0
Source: North Carolina State Center for Health Statistics; 2010 US Census
The cancer incident rate includes each case of cancer regardless of site. The cases are aggregated and calculated on a
per 100,000 person basis.
Colon/Rectum Cancer Incidence Rate per 100,000 (2005-2009)
70
59.4
60
50
40
52
45.5
45.1
44.4
38.1
46.3
46.1
40.4
34.9
41.7
39.5
33.7
30
20
10
0
Source: North Carolina State Center for Health Statistics; 2010 US Census
The colon/rectum cancer incidence rate is limited to cancers located in the colon and rectum. The cases are
aggregated and calculated on a per 100,000 person basis.
04/21/2014
Appendix 4
Lung/Bronchus Cancer Incidence Rate per 100,000 (2005-2009)
120
100.9
96.1
100
75.9
80
70.8
73.1
76.8
81.8
80
81.4
79.7
71.1
75.9
67.2
60
40
20
0
Source: North Carolina State Center for Health Statistics; 2010 US Census
The lung/bronchus cancer incidence rate is limited to cancers located in the lungs and bronchi. The cases are
aggregated and calculated on a per 100,000 person basis.
Female Breast Cancer Incidence Rate per 100,000 (2005-2009)
180
160
137
140
139.2
138.8
127.6
125.9
126.8
136
108.9
120
100
157.2 154.1
156.4
154.5
94.8
80
60
40
20
0
Source: North Carolina State Center for Health Statistics; 2010 US Census
The female breast cancer incidence rate is limited to cancers located in female breast. The cases are aggregated and
calculated on a per 100,000 person basis.
04/21/2014
Appendix 4
Prostate Cancer Incidence Rate per 100,000 (2005-2009)
300
243.8
250
216.8
200
158.3
150
140.2
118.3
141
124.3
139
103.1 109.4
108.9
95.1
83.8
100
50
0
Source: North Carolina State Center for Health Statistics; 2010 US Census
The prostate cancer incidence rate is limited to cancers located in prostate. The cases are aggregated and calculated
on a per 100,000 person basis.
Percentage of Total Hospital Discharges Related to Septicemia
6.00%
5.01%
5.00%
4.00%
3.00%
2.61%
2.90%
2.14%
2.00%
1.67%
1.22%
2.40% 2.40%
1.47% 1.46%
1.30%
1.00%
0.00%
0.00%
0.00%
Source: NC Hospital Inpatient Discharge and Ambulatory Surgery Center Data
The percentage of total hospital discharges related to septicemia is determined by calculating the percentage of the
total hospital visits caused septicemia. It is important to note that the hospital in Bladen County did not have any
cases while Hoke County does not have a hospital
04/21/2014
Appendix 4
Appendix 5: Contact Research Organization Contact Information
AAIPharma Services Corp.
www.aaipharma.com
(910) 254-7000 Fax: (910) 815-2300
2320 Scientific Park Drive
Wilmington, NC 28405-1800
AAIPharma Services provides drug product
developments services such as formulation
development, analytical chemistry and
manufacturing. The company's solid-dose
and parenteral manufacturing facilities
provides clinical and commercial supplies
on contract.
Blitz Research
http://www.blitzresearch.com
(910) 332-4000
5512 Business Drive
Wilmington, NC 28405
Blitz Research offers a wide range of
services including pharmacovigilance,
patient recruitment, and market analysis.
Catalent
www.catalent.com
(919) 481-4855 Fax: (919) 481-4908
P.O. Box 13341
Research Triangle Park, NC 27709
Catalent is a full-service CRO focusing in
the development, delivery and supply of
pharmaceuticals.
Chiltern International
www.chiltern.com
(910) 338-4760 Fax: (910) 799-1467
2528 Independence Blvd., Suite 101
Wilmington, NC 28412
Chiltern is a leading, full service, global
Contract Research Organization with
extensive experience in the management of
Phase I-IV clinical trials across a broad
range of therapeutic areas and contract
staffing solutions.
05/31/2013
Clinipace Worldwide Inc.
www.clinipace.com
(919) 224-8800 Fax: (919) 321-2322
P.O. Box 14684
Research Triangle Park, NC 27709
Clinipace is a clinical research software
company that provides a single, integrated
data capture and study management
platform for post-approval research and
registries.
Covance
www.covance.com
(888) 268-2623 Fax: +86 10 6569 4119
210 Carnegie Center
Princeton, NJ 08540
Covance is provides comprehensive drug
development services with focuses in
nonclinical development, clinical
development, and periapproval and market
access.
The EMMES Corporation
www.secure.emmes.com/emmesweb
301-251-1161
401 N. Washington St., Suite 700
Rockville, MD 20850
EMMES offers services as a professional
partner to clinicians, scientists, and program
leaders. EMMES provides the full range of
Contract Research Organization expertise
necessary to conduct clinical research with a
firm scientific basis that is fully compliant
with national and international regulatory
guidelines.
Appendix 5
ICON Clinical Research
www.iconclinical.com
(919) 294-2200 Fax: (919) 294-2360
79 TW Alexander Drive, 4501 Research
Commons, Suite 300
Durham, NC 27709
ICON provides drug development and
clinical services, from compound selection
to Phase I-IV clinical studies, in areas
including oncology, cardiovascular and
biosimilars.
INC Research (Wilmington)
www.incresearch.com
(910) 509-4700 Fax: (910) 509-4701
1011 Ashes Drive
Wilmington, NC 28405
INC Research specializes in providing
clinical trials services to support global
Phase I - Phase IV studies, and we offer
deep therapeutic clinical trial expertise
across a wide variety of indications, as well
as for special populations, such as women
and pediatrics.
inVentiv Health
http://www.inventivhealth.com
(609) 951-6800
504 Carnegie Center
Princeton, NJ 08540
InVentiv offers a full suite of services that
support Phase I (first-in-human) through
Phase IV (post-launch) clinical trials.
Jubilant Clinsys
www.clinsys.com
(919) 518-8888 Fax: (919) 848-8461
8540 Colonnade Center Drive, Suite 407
Raleigh, NC 27615
Jubilant Clinsys is a scientifically focused
contract research organization that provides
pharmaceutical, biotechnology and medical
device companies with a full range of
services in support of Phase I – IV drug and
device development
04/21/2013
Modoc Research Services
www.modocresearch.com
(910) 777-2671 Fax: (910) 777-2676
219 Racine Drive, Suite D
Wilmington, NC 28404
Modoc Research Services works with
biotechnology and pharmaceutical
companies to develop and conduct Proof of
concept (POC) and Phase I-II clinical trials.
They offer a full range of support services.
Novella Clinical (Wilmington)
www.novellaclinical.com
(910) 791-8438 Fax: (910) 791-8317
575 Military Cutoff Road, Suite 100
Wilmington, NC 28405
Novella Clinical is a full service clinical
research organization dedicated to clients in
the oncology, medical device and
biopharmaceutical industries.
OrphanReach
www.orphan-reach.com
(413) 821-0022
1408 Main Street
Agawam, MA 01001
OrphanReach is the first of its kind Global
Service Alliance dedicated to Orphan and
Rare Disease Drug Development offering
the full spectrum of clinical development
services.
PAREXEL International Corp.
www.parexel.com
(919) 544-3170 Fax: (919) 544-3410
2520 Meridian Parkway, Suite 200
Durham, NC 27713
Parexel provides drug-development and
launch services, including clinical
development, integrated advanced
technologies, regulatory affairs consulting
and commercialization services.
Appendix 5
Pharm-Olam International
www.pharm-olam.com
(919) 237-4300 Fax: (919) 237-4301
P.O. Box 14089
Research Triangle Park, NC 27709
Pharm-Olam provides Phase I-IV clinical
research services with focuses on data
services and pharmacovigilance.
PPD
www.ppdi.com
(910) 251-0081 Fax: (910) 762-5820
929 N. Front St.
Wilmington, NC 28401
PPD, a global contract research
organization, provides drug discovery,
development and lifecycle management
services to pharmaceutical, biotechnology,
medical device, academic and government
organizations.
PRA International
www.praintl.com
(919) 786-8200 Fax: (919) 786-8201
4130 Park Lake Ave., Suite 400
Raleigh, NC 27612
PRA International, a global CRO, provides
serves clients across all phases of
pharmaceutical and biotech drug
development by combining therapeutic and
operational expertise with local knowledge.
Premier Research
www.premier-research.com
(215) 282-5500
1500 Market Street
Philadelphia, PA 19102
Premier Research is a global contract
research organization (CRO) serving
biotech, pharmaceutical, and medical device
corporations. Its services include clinical
research and regulatory outsourcing in the
areas of analgesia; neurology; infectious,
cardiovascular, and respiratory disease;
dermatology; and oncology.
04/21/2013
Quintiles
www.quintiles.com
(919) 998-2000 Fax: (919) 998-2003
4820 Emperor Blvd.
Durham, NC 27703
Quintiles is a contract research organization
that provides clinical- and productdevelopment services for pharmaceuticals,
biosimilars and medical devices.
Research Pharmaceutical Services
www.rpsweb.com
(215) 540-0700 Fax: (215) 540-0770
520 Virginia Drive
Fort Washington, PA 19034
Research Pharmaceutical Services provides
comprehensive global Phase I-IV clinical
development solutions to the
Pharmaceutical, Biotechnology, Medical
Device and Diagnostic industries.
Sarah Cannon Research Institute
www.sarahcannonresearch.com
(877) 691-7274
3322 West End Ave., Suite 900
Nashville TN 37203
Sarah Cannon Research Institute works with
sponsors at all levels on study design, data
analysis, interpretation, protocol
development, and clinical study reports.
SynteractHCR
(760) 268-8200 Fax: (760) 929-1419
5759 Fleet Street, Suite 100
Carlsbad, CA 92008
SynteractHCR is a full-service CRO with
more than two decades of success delivering
customized Phase I-IV clinical trial
solutions, contributing to numerous product
approvals across multiple therapeutic areas.
Appendix 5
Theorem Clinical Research
www.theoremclinical.com
(484) 679-2400 Fax: (484) 679-2410
630 Allendale Road
King Of Prussia, PA 19406
Theorem Clinical Research combines
Phase I–IV solutions with specialized
therapeutics expertise to execute perfectly
aligned trials.
Worldwide Clinical Trials
www.wwctrials.com
(310) 786-9100 Fax: (310) 786-9102
401 N. Maple Drive
Beverly Hills, CA 90210
Worldwide Clinical Trials is a global CRO
that provides full-service drug development
services to the pharmaceutical and
biotechnology industries.
04/21/2013
Appendix 5
Appendix 6: Clinical Research Support Company Contact Information
Biostatistics
Biostudy Solutions
www.biostudysolutions.com
(910) 792-9706 Fax: (866) 830-3720
4008 Caesar Court
Wilmington, NC 28405
Biostudy Solutions provides
pharmacokinetic and statistical services and
study design related to BA/BE testing.
PharPoint Research (Wilmington)
www.pharpoint.com
(910) 790-0482 Fax: (866) 589-4865
1985 Eastwood Road, Suite 100
Wilmington, NC 28403
PharPoint Research provides contract
clinical management, programming, and
biostatistics consulting and operational
services. The company's biostatistics
practice is based in its Wilmington office
Triangle Biostatistics
http://www.trianglebiostatistics.com
(888) 316-3544 Fax: (888) 316-8753
1900 S. Main St., Suite 108
Wake Forest, NC 27587
Triangle Biostatistics has experience in
regulatory submissions worldwide and
provides a variety of Statistical consulting
and programming services.
04/21/2014
Clinical Trials Data
Management
Clinical Ink
http://www.clinicalink.com
(336) 714-7402
100 N Cherry St
Winston-Salem, NC 27g101
Clinical Ink offers electronic source
documents-providing the first true
Electronic Source Record (ESR) in the
clinical trials market.
OptumInsight
http://www.optuminsight.com
(888) 445-8745 Fax: (952) 833-7201
13625 Technology Drive
Eden Prairie, MN 55344
OptumInsight specializes in improving the
performance of the health system by
providing analytics, technology and
consulting services that enable better
decisions and results.
SAS Institute
www.sas.com
(919) 677-8000 Fax: (919) 677-4444
100 SAS Campus Drive
Cary, NC 27513-2414
SAS software accelerates knowledge
discovery in biomedical product
development.
Appendix 6
Clinical Trial Insurance
Arthur J. Gallagher Risk Management
Services
www.ajg.com
(910) 509-9000 Fax: (910) 509-9006
1430 Commonwealth Drive, Suite 302
Wilmington, NC 28403
Walker Taylor Agency/Arthur J. Gallagher
Risk Management Services serves the
pharmaceutical and life sciences industries
for property, casualty insurance,
professional liability and executive liability
protection.
Aquesta Insurance Services
(Glasgow Hicks Insurance Agency)
www.aquesta.com
(910) 794-6100
3807 Peachtree Avenue
Wilmington, NC 28403
Glasgow Hicks Insurance Agency provides
insurance for the life science and clinical
trial industries.
Human Resources Support
Babb McGrew
www.babbmcgrew.com
(910) 791-8570 Fax: (910) 791-8579
6209 Oleander Drive, Suite 102
Wilmington, NC 28403
Babb McGrew is a full service life science
executive search firm serving
pharmaceutical, biotechnology, healthcare
and marketing companies.
04/21/2014
Hawthorne Search
http://hawthornesearch.com
(910) 798-1800 Fax: (910) 798-2811
1319 Military Cutoff Road, Suite CC #147
Wilmington, NC 28405
Hawthorne Search is a recruitment firm with
specialization in recruiting for the
pharmaceutical and biotechnology
industries.
Human Capital Solutions
www.humancs.com
(910) 332-3535 Fax: (910) 509-9833
1437 Military Cutoff, Suite 201
Wilmington, NC 28403
HCS is a business consulting firm
specializing in executive search, human
resources consulting, leadership, learning
and employee development, business
strategy, lean manufacturing and quality
systems and personal coaching.
ThinkingAhead Executive Search
http://www.thinkingahead.com
(910) 509-3831 Fax: (910) 509-3832
700 Military Cutoff Rd, Suite 305
Wilmington, NC 28405
ThinkingAhead is an executive recruiting
firm with offices in the United States and
Europe. The Wilmington Office focuses on
Pharmaceutical and Medical Device
recruitment.
Independent Consultants
Amanda Grim's GCP Audits
(919) 349-4798
403A Harper Ave.
Carolina Beach, NC 28428
Amanda Grim's GCP Audits offers GCP
audits and training.
Appendix 6
Argent Rx Solutions
www.argentrx.com
(910) 547-3355
1925 Hallmark Lane
Wilmington, NC
Argent Rx Solutions provides customized
market and financial consulting for
pharmaceutical companies.
BioClin Consulting LLC
www.bioclinconsulting.com
(910) 398-7769
6603 Wheatfields Court
Wilmington, NC 27411
BioClin Consulting provides clinical trial
management services.
Biopharmaceutech International
linkedin.com/pub/david-johnston/1/633/1aa
[email protected]
A biotechnology and pharmaceutical
consultancy specializing in helping growing
companies with strategic advice.
Cape Fear Research Consultants
www.capefearresearch.com
(910) 399-2220
4217 Pine Hollow Road
Wilmington, NC 28412
Cape Fear Research Consultants provides
clinical trials services including report
writing, auditing, site selection and
monitoring, training and education.
Coastal Pharmaceutical Consultants, Inc
(910) 259-8877
7950 Old River Road
Burgaw, NC 28425
Coastal Pharmaceutical Consultants
provides regulatory and quality consulting
services, including assistance with product
development regulatory strategies,
consulting on GMP and GCP issues, and
assessment of QC and QA functions.
04/21/2014
DMS Clinical Research Services
2330 Cedar Hill Road
Leland, NC 28451
DMS Clinical Research Services has
expertise in conducting, monitoring, and
managing clinical trials.
Hashimoto Consulting Services
www.lanihashimoto.com
(910) 617-6385
925 Rivage Promenade
Wilmington, NC 28412
Hashimoto Consulting Services bridges
patients and research providing patient
recruitment services and consulting for
pharmaceutical, biotechnology, and medical
device clinical trials.
Hermes, LLC
www.hermesllc.com
(910) 375-5454
331 Cape Fear Blvd.
Wilmington, NC 28401
Hermes designs, develops and implements
research projects, as well as provides
technical assistance and training services.
KButler GxP Consulting, LLC
113 Wyndham Way
Wilmington, NC 28411
KButler GxP Consulting provides QA
compliance expertise to pharmaceutical
companies.
MSS Pharmaceutical Consulting, Inc.
2017 Woodwind Drive
Leland, NC 28451
MSS Pharmaceutical Consulting provides
expertise in clinical monitoring, CRA
resourcing, and CRA management.
Appendix 6
Navigator Life Science Advisory
www.navigatorlsa.com
(910) 233-5037
Navigator Life Science Advisory is a
consulting firm that specializes in drug
discovery and development, drug safety,
preclinical and clinical, FDA and EU
regulatory affairs.
Outsourcing Support Services, Inc
www.outsource-support.com
(317) 408-0286
Outsourcing Support Services offers
services in outsource management, QA
facility audits, and preclinical study
monitoring.
Pharmalogx LLC
www.pharmalogx.com
2108 Forest Lagoon Place
Wilmington, NC 28405
Pharmalogx provides advisory services to
life science companies, particularly in the
areas of manufacturing, compliance and
organizational structuring.
Rothermel Clinical Research Consulting
LLC
(910) 579-5263
631 Eastwood Park Road
Sunset Beach, NC 28468
Rothermel Clinical Research Consulting
provides contract medical writing and
consulting, specializing in oncology clinical
research.
04/21/2014
Spataro & Associates
www.clinicalsupplysolutions.com
(919) 491-0844 Fax: (866) 242-1908
1787 Riverbend Drive
Burgaw, NC 28425
Spataro & Associates provides
pharmaceutical consulting and training
services in the areas of clinical supply chain
operations, project management, process
excellence, and compliance.
Wagoner Consulting
www.wagonerconsultingllc.com
910-386-9019
PO Box 15729
Wilmington, NC 28408
Wagoner Consulting provides cost-effective
professional regulatory and quality assurance
consulting services in the areas of medical
devices, biologic products, pharmaceuticals, and
consumer products.
Information Technology
Bluewater Technology Partners
http://www.bluewatertechnc.com
109 Braxlo Ln.
Wilmington, NC 28409
Bluewater Technology Partners is an
innovative consultancy focused on
information technologies for life sciences,
pharmaceuticals, biotechnology and
bioanalytical as well as general information
technology initiatives.
Appendix 6
Laboratory Testing Services
Marketing
Eurofins Scientific
www.eurofins.com
(866) 324-8691
14100 Park Meadow Drive, suite 110
Chantilly, Virginia 20151
Eurofins operates one of the industry's
leading central laboratories worldwide,
supporting clinical trials in more than 50
countries across six continents.
A.Revell Communications
www.arevell.com
(919) 909-1097
11 Church Street
Wilmington, NC 28401
A.Revell public relations, events and
creative marketing services helps you refine
your message and proclaim your position to
the market.
Quality Chemical Laboratories
www.qualitychemlabs.com
(910) 796-3441 Fax: (910) 796-3425
3400 Enterprise Drive
Wilmington, NC 28405
Quality Chemical Laboratories offers
contract analytical and microbiological
testing services to pharmaceutical
companies, including raw-material and
finished-product testing, stability testing,
method development and validation.
Bon's Eye Marketing
www.bonseyeonline.com
(910) 399-2700 Fax: (866) 830-3270
4008 Caesar Court
Wilmington, NC 2840
Bon’s Eye Marketing provides a full range
of services specifically tailored to CROs
including: Media and PR, Online Marketing,
Brand Building, and Market Messaging.
Solstas Lab Partners
www.nextwavelabs.com
(910) 202-2400 Fax: (910) 202-2499
1915 S. 17 St., Suite 100
Wilmington, NC 28401
Solstas Lab Partners provides medical
laboratory testing services to hospitals,
nursing homes, home health, clinics, urgentcare facilities and other businesses.
Wilmington Pathology Associates
www.wilmingtonpathology.com
(910) 362-9511 Fax: (910) 362-9512
1915 S. 17 St., Suite 100
Wilmington, NC 28401
Wilmington Pathology Associates offers
surgical pathology and cytopathology
diagnostic services.
04/21/2014
Medical Writing
Regulatory Writing Solutions
https://sites.google.
com/site/regulatorywritingsolutions/ourcompany
(910) 794-5283
Regulatory Writing Solutions provides
professional regulatory medical writing and
consulting services to the pharmaceutical,
biotechnology, and CRO industries
Modoc Research Services
www.modocresearch.com
(910) 777-2671 Fax: (910) 777-2676
219 Racine Drive, Suite D
Wilmington, NC 28404
Modoc Research Services works with
biotechnology and pharmaceutical
companies to develop and conduct Proof of
concept (POC) and Phase I-II clinical trials.
They offer a full range of support services.
Appendix 6
Patient Recruitment
ClinEdge
www.clin-edge.com
(857)496-0054
137A Lewis Wharf
Boston, MA 02110
ClinEdge provides a range of marketing and
patient recruitment services as well as a
range of clinical operations services.
PMG Research of Wilmington
www.pmg-research.com/wilmington
(910) 799-5500 Fax: (910) 799-1002
1907 Tradd Court
Wilmington, NC 28401
PMG Research of Wilmington conducts
Phase II, III and IV clinical trials in a wide
range of therapeutic areas.
Endeavour Clinical Solutions
www.endeavour-clinical.com
127 E. 4th Street
Corning, NY 14830
Endeavour provides consultative services for
global clinical development and health
outcomes intended to transform clinical
research participation from study planning
and feasibility through patient enrollment,
retention, and improved health outcomes.
Pharmaceutical Sales Training
Proficient Learning
www.proficientlearning.com
(910) 509-0104 Fax: (910) 509-9105
1900 Eastwood Road, Suite 15
Wilmington, NC 28403
Proficient Learning offers sales training in
medical devices, oncology pharmaceuticals
and offers fully customizable training
MediciGlobal
www.mediciglobal.com
(484) 674-6800
1014 West 9th Ave.
King of Prussia, PA 19406
MediciGlobal is a specialty patient
recruitment-retention firm serving the
clinical trials industry.
Trial Management Associates, LLC
www.trialmgt.com
(910) 338-1555 Fax: (866) 826-1581
1302 Medical Center Drive
Wilmington, NC 28401
Trial Management Associates is a clinical
research management company that
manages and executes Phase II-IV industrysponsored clinical research studies.
04/21/2014
Appendix 6
Appendix 7: Drug, Medical Device, & Testing Development Contact
Information Drug Development
Alvogen
www.alvogen.com
(973) 796-3400
10 Bloomfield Avenue
Pine Brook, NJ 07058
Alvogen is an international, privately-owned
specialty pharmaceutical company focused
on the development, manufacturing and
marketing of generic pharmaceuticals,
biosimilar products and OTC (over-thecounter medicines).
CardioPharma
www.cardio-pharma.com
(910) 791-1361 Fax: (910) 794-1829
100-A Eastwood Center Drive, Suite 117
Wilmington, NC 28403
CardioPharma develops combinatorial
products to treat cardiovascular disease.
Furiex Pharmaceuticals
www.furiex.com
(919) 456-7800
3900 Paramount Parkway, Suite 150
Morrisville, NC 27560
Furiex Pharmaceuticals conducts and
finances early-stage preclinical and proofof-concept drug development to clinical
milestones with partner companies.
MARBIONC Development Group LLC
www.marbionc.org
(910) 962-2330 Fax: (910) 962-2410
5600 Marvin K. Moss Lane
Wilmington, NC 28409
MARBIONC Development Group is a notfor-profit organization that develops and
markets new products and technologies
derived from marine and aquatic organisms.
Osmotica Pharmaceutical Corp.
www.osmotica.com
(910) 509-0114 Fax: (910) 509-0115
1205 Culbreth Drive, Suite 200
Wilmington, NC 28405
Osmotica Pharmaceutical specializes in
drug-delivery technologies and neurologybased therapies, including a treatment for
Parkinson's disease.
Wilmington Pharmaceuticals
www.wilmingtonpharma.com
(910) 509-0097 Fax: (888) 482-8024
P.O. Box 16509
Wilmington, NC 28408
Wilmington Pharmaceuticals patientfriendly, fast-dissolving formulations for
established medicines with an unmet patient
need for simpler, more reliable dosage
forms.
Leonard Consulting, LLC
(910) 232-3281
2201 S. Live Oak Pkwy
Wilmington, NC 28403
Leonard Consulting provides consulting
services focused on development of novel
NDA products and 505(b)(2)/Abridged
Hybrid products in the US and EU.
04/21/2014
Appendix 7
Medical Device Development &
Testing
Testing Development and
Manufacturing
Baxano Surgical
www.baxanosurgical.com
(910) 332-1700
301 Government Center Drive Suite 100.
Wilmington, NC 28403
Baxano Surgical is a medical device
company focused on designing, developing
and marketing products to treat degenerative
conditions affecting the spine lumbar region.
AccuGenomics
www.accugenomics.com
(910) 332-6522 Fax: (910) 679-4263
1410 Commonwealth Drive, Suite 105
Wilmington, NC 28403
Accugenomics develops gene expression
tests to diagnose and monitor cancer
treatment.
Cortech Solutions
www.cortechsolutions.com
(910) 362-1143 Fax: (910) 362-1147
1409 Audubon Blvd., Unit B1
Wilmington, NC 28403
Cortech Solutions is the single source for
sales and support for all the tools a
neuroscientist needs for advanced brain
research.
MicroGuard Consulting LLC
www.microguardconsulting.com
(910) 616-0066
4837 Wedgefield Drive
Wilmington, NC 28409
MicroGuard Consulting provides
microbiology consulting services to
pharmaceutical and biotechnology
companies.
MindSkid Labs
www.MindSkidLabs.com
910-202-2202
Wilmington, NC 28405
MindSkid Labs is a virtual medical device
company. Our vision is to research and
develop innovative medical devices, which
improve surgical outcomes and patient care.
Our customers are Ophthalmologists who
conduct cataract surgery.
OrthoKinetic Technologies LLC
www.orthokintech.com
(910) 253-9883 Fax: (910) 253-9884
2790 Creekbridge Court
Southport, NC 28461
OrthoKinetic Technologies is a consulting
and testing company who guides orthopedic
and neurosurgical medical device companies
in the areas of regulatory and preclinical
strategies for FDA submissions.
04/21/2014
Appendix 7