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March 2016
A CenterWatch Feature Article Reprint
Volume 23, Issue 03
CROs juggle proprietary and commercial systems
Adopt customized EDC
and CTMS while offering
own niche solutions
By Karyn Korieth
T
hird-party vendors have come to dominate the clinical trial technology sector,
which was led by CROs a decade ago.
At the same time, many large CROs continue
to invest in technology solutions to differentiate their services and offer greater efficiencies in clinical development processes.
The eClinical solutions market, which
includes electronic data capture (EDC)
and clinical trial management systems
(CTMS), could generate total global sales of
$5 billion by 2018, representing a five-year
annual growth rate of 13.5%, according to a
recent report from global market research
company MarketsandMarkets. Yet much
of the growth in clinical trial technologies
is expected to come from niche providers
rather than in-house systems developed by
CROs.
Icon Chief Information Officer Tom O’Leary
said there has been a “seismic shift” away from
internally developed EDC and CTMS systems
during the past 15 years. Today, the majority of
CROs use commercially developed enterprise
applications to support clinical development
in phase II and phase III trials. Phase IV and
post-marking studies tend to have more unique
requirements that are often supported by specialist applications and software systems from
CROs and niche providers.
Size of the global EDC market
($U.S. in billions)
e=estimated
p=projected
$5.9
$4.8
$3.7
$3
2014
2016e
2018p
2020p
Source: MarketsandMarkets
“There is little doubt that a number of
niche providers have taken a revenue stream
away from CROs when it comes to technologies. There are fewer CROs in the market today than there were 15 years ago. The CROs
who didn’t have a broad technology and service offering have been acquired or left the
market completely,” said O’Leary.
Yet technology remains a big part of CRO
service offerings, particularly as CROs and
sponsors feel pressure to contain costs and
expedite the clinical trial process. Leading CROs have adapted their businesses to
customize commercially available EDC and
CTMS application systems and continue
to grow and diversify their technology offerings. As the market has evolved, large
CROs have focused on ways to differentiate
their technology systems, work cooperatively with a range of third-party providers
and develop solutions to integrate platforms
across companies and trials.
“There is a huge opportunity for smart
CROs to do things with technology to distinguish and differentiate their services,”
The CenterWatch Monthly (ISSN 1556-3367). Volume 23, Issue 03. © 2016 CenterWatch
said Glen de Vries, president and co-founder
of Medidata Solutions.
Changing EDC landscape
The industry began implementing EDC,
which has become the most widely used
clinical trial technology, in the late 1990s after the rise of the Internet allowed for development of Web-based software that investigative site staff could access with existing
computers.
In the early days, CROs worried that EDC
technology would cut into core revenue
streams by requiring fewer monitors and
fewer billable hours. Many developed inhouse technologies and systems or acquired
small EDC companies to support digitalized
data collection. Around the same time, a
variety of new and established technology
vendors entered the marketplace.
About eight years ago, the eClinical space
began to consolidate through more than
a dozen deals, including Oracle’s acquisition of Phase Forward in 2010. Technology
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Buyer
Acquired company
Primary solution(s)
Year
Bioclinica
Clinverse
Automated clinical
trial payment firm
2016
PRA Health
Sciences
Value Health
Solutions
Clinical trial management
applications
2015
Icon
MediMedia
Integrated scientific
and market access
2015
PAREXEL
ClinIntel
Randomization trial and
supply management
2014
Bioclinica
Blueprint Clinical
Risk-based monitoring
2014
Icon
AptivSolutions
Design and execution
of adaptive
2014
Icon
Firecrest
Site management
and performance
2011
companies aimed to offer sponsors a single
platform to meet all of their data collection and management needs on a global
level. EDC platforms, for example, could be
coupled with clinical data management systems (CDMS) or interactive voice response
systems (IVRS) as an integrated process.
As the market consolidated and evolved, it
became increasingly difficult and expensive
for CROs to maintain their own in-house
systems. Some CROs divested their clinical
trial technology offerings.
“The CROs discovered that once they had
a system, they needed to be able to maintain
it to adjust to a new regulatory environment.
It’s a full-time job,” said François Audibert,
vice president of Global Consulting in the
eHealth Solutions segment at Bioclinica,
a specialty clinical trials services provider.
“They had to make a decision. Do we want
to invest all of that money and effort into
this? Or do we want to work with a company that can provide tech as a core offering
and concentrate on bringing innovation to
our services?”
Today, most major CROs use commercially developed EDC and CTMS systems
from multiple vendors; some large CROs
continue to support internally developed
2 The CenterWatch Monthly | March 2016
Source: CenterWatch analysis of company reports and websites
CTMS systems, but most also use systems
developed by third-party vendors in order
to accommodate sponsor-company preferences. CRO teams with both IT and clinical
trials expertise typically work with vendors
to customize the software for particular
studies or therapeutic needs.
“Our IT department works hand-in-hand
with our business counterparts to ensure the
functionality required in the system reflects
our market-leading practices,” said Quintiles Global Chief Technology Officer Malcolm Postings. “There is effort required to
customize the ‘off-the-shelf’ versions, which
is an overhead, but one we balance with additional services. We always speak with the
main IT suppliers to help influence future
versions with our requirements.”
Medidata’s de Vries said CRO teams can
add value to commercially available platforms. Customization work allows them to
differentiate their in-house technology systems.
“There are really good technology teams
at CROs. They figure out how to integrate
what they are getting at scale from a company like Medidata with things that are going
to help them differentiate parts of their business. Whether it’s figuring out how to look at
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or enhance the way they deal with analytics
or connect it to their other operational systems, the idea is that they are going to build
on that core platform,” said de Vries.
Leading companies also invest in technology segments through acquisitions. This can
expand and diversify their service offerings,
and support the in-house technology teams
that develop and integrate software applications and systems across their service lines.
For example, last year PRA Health Sciences acquired clinical development software company Value Health Solutions to
further develop its Predictivv clinical trial
management platform. Icon has also made
several acquisitions recently to build its
technology and service offerings and to
differentiate its technology systems. The
acquisitions of Firecrest Clinical and Aptiv
Solutions provided technologies for patient
recruitment and adaptive clinical trials that
are different than what other CROs offer.
Icon also has teams that develop and integrate software applications across all of its
service lines, which include platforms for
data collection, information resources and
technology (IRT) and imaging. But O’Leary
said the CRO doesn’t view its technology as
a core business.
Leading CROs with internally developed CTMS systems
Leading CRO (in alphabetical order)
System
Covance
Xcellerate
Icon
Iconik
Medpace
ClinTrak
PAREXEL
Impact
PPD
Preclarus
PRA Health Sciences
Predictivv
Quintiles
Infosario
Source: CenterWatch analysis of company reports and websites
“Technology enables us to differentiate
our services more efficiently, which in turn
enables us to help our clients to take time
and cost from the development program,”
he said.
PAREXEL is unique in that it continues
to invest in its technology division, PAREXEL Informatics, as a core area. The division
competes directly with third-party clinical
development software vendors. PAREXEL
hosts and maintains its own DataLabs EDC,
but the company also can build and maintain third-party EDC software depending
on a specific client’s preference. In December, PAREXEL launched a new, simplified
Notable recent acquisitions by technology solutions providers
Buyer
Acquired company
Primary solution(s)
Year
ERT
PHT
ePRO and mobile clinical trial
applications
2015
Medidata
Solutions
Patient Profiles
Risk-based monitoring
applications
2014
IMS Health
Cegedim
Customer relationships
management
2014
ERT
InvivoData
ePRO
2012
IMS Health
DecisionView
Study planning and execution
2012
Oracle
ClearTrial
Resource and capacity
planning
2012
Medidata
Solutions
Clincial Force
CTMS
2011
Oracle
PhaseForward
EDC/CTMS
2010
3 The CenterWatch Monthly | March 2016
Source: CenterWatch analysis of company reports and websites
version of its CTMS aimed at small-tomidsized biopharmaceutical companies. Its
technology platform includes randomization and trial supply management (RTSM)
and medical imaging applications. The CRO
integrates the technologies into its research
processes and also makes them commercially available through a partner program.
David Kiger, vice president, product strategy at PAREXEL Informatics, said CRO
software teams have unique clinical, regulatory and commercialization expertise that
can lead to innovations in the research and
development process. For example, PAREXEL created a platform called LIQUENT
InSight to manage the entire lifecycle of a
regulatory product, from early planning
through retirement, as a result of many direct conversations with customers about the
challenges they encountered in standardizing data to meet legislative requirements.
“Independent software vendors tend to
focus on features. As part of a CRO, the
PAREXEL Informatics team brings industry domain expertise to the technology
solutions,” Kiger said. “With our focus in
regulatory services, PAREXEL begins the
design and capture of data with the end in
mind. Domain expertise is critical for the
therapeutic area requirements. For example,
how you design electronic collection for a
disease such as Lupus can be very different
than how you design an obesity study for
outcomes/events capture.”
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A new direction
The shift away from internally developed
EDC systems has forced major CROs to rethink their business strategies and evaluate
how technologies can best be used to improve clinical trial processes going forward.
“We needed new thinking to take that extra step into the 2020 world, which is where
we are heading pretty quickly, and define a
future roadmap,” said Quintiles’ Postings,
an IT and business strategy expert who
joined Quintiles last year. “How do you have
wider connections to multiple data sources?
How do you offer insight as a service? How
do we use our data scientists to really look
at biomarkers and amazing amounts of detail?”
Quintiles has a suite of integrated data
systems and services under the Infosario
brand, which includes CTMS, clinical trial
design, safety, an investigative site portal,
analytics and regulatory information management technologies. As it moves forward,
an important component of the IT strategy
involves forming partnerships with technology companies—both large and small—to
develop products and services that can address critical issues such as integrating systems across companies and trials, improving analytics and reporting, connecting
information through data hubs or aggregating data from wearable sensors.
“It’s a mixture of the software, which is ITfocused, blended with our knowledge,” said
Postings. “We are not developing software
to sell software. But it’s a core component of
everything we do and it’s going to become
more and more important.”
One of the future challenges for CROs
is keeping ahead of new technology developments in the marketplace. Not only is
4 The CenterWatch Monthly | March 2016
Primary EDC platforms used by select CROs
Leading CRO (in alphabetical order)
Icon
Medidata Solutions, Oracle, sponsor
systems, Datatrak for phase IV studies
PAREXEL
PAREXEL Informatics DataLabs EDC
PPD
Medidata Solutions, Oracle, OmniComm
Systems
Quintiles
Oracle, Medidata Solutions
Source: CenterWatch analysis of company reports and websites
there a profusion of new systems flooding
the market, such as CTMS, electronic trial
master files (eTMF) and regulatory information management (RIM), new clinical trial
platforms increasingly require a mobile service component and mobile interface. The
market also is moving toward technologies
developed by more niche expert providers in
smaller areas.
Postings said Quintiles is focusing its integration efforts across four domains: business process management and workflow;
event management; API gateway; and systems/applications integration.
“There is a convergence of systems and
technologies taking place and a greater demand for a more seamless and integrated
solutions with single sign-on capabilities,”
said O’Leary. “CROs who have learned to
collaborate and integrate their capabilities
and processes with third-party providers
are the CROs who will continue to succeed
in the future.”
Looking ahead
Third-party vendors are expected to increase their market share in the clinical trial
technology sector going forward; companies
are continuing to make acquisitions that ex-
pand their technology offerings and can be
integrated into existing platforms or business segments. Bioclinica’s recent acquisition of Clinverse, for example, adds clinical
trial payment services to its offerings, while
Medidata recently boosted its risk-based
monitoring software through the acquisition of Patient Profiles.
CROs, however, can continue to operate
successfully in this space if they can adapt
their technology businesses, diversify their
offerings and differentiate themselves in the
marketplace.
“Technology now is creating new ways of
performing monitoring, new ways of looking at decision-making through therapeutic
experts and new business-process tools. The
world is changing and it’s changing for the
better. But you have to get on the train and
ride with it. You can’t really afford to be left
behind,” said Quintiles’ Postings. Karyn Korieth has been covering the clinical trials industry for CenterWatch since
2003. Her 30-year journalism career includes
work in local news, the healthcare industry and national magazines. Karyn holds a
Master of Science degree from the Columbia
University Graduate School of Journalism.
Email [email protected].
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