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IT Solutions
IT Solutions Your information technology directory 26| Company Directory 25| Adverse Events Clinical Project Management 30| Custom Application Development Data Collection and Management 31| Data Mining and Visualization Data Warehousing Document Management Electronic Data Capture (EDC) 32| Electronic Submissions IT Consulting Knowledge Management Statistical Analysis Count on the Applied Clinical Trials 2003 IT Solutions Directory to learn who provides applications for clinical trials— and how to reach them. To find the right tools for your trials, search the categorized directory. 33| Training Trials Management and Administration Validation 34| Web-Based Software Wireless/Mobile Technologies Other Applications 24 APPLIED CLINICAL TRIALS SUPPLEMENT actmagazine.com March 2003 DataLabs DataLabs CTMS DataLabs CTMS is the first Internet-based product that integrates the elements of project, data, and document management into a single application. Based in Microsoft’s .NET framework and servers, this integrated approach provides significant benefits, including an accelerated time to market, lower development costs, and improved research quality. Datapharm Australia Pty. Ltd. SMART SMART (Smooth Monitoring A Resource Tool) was developed by Datapharm to assist project managers of clinical trials to assess and track monitoring requirements over several projects and to adjust estimates based on actuals iteratively. It is quick to use and allows monitoring of actuals vs. estimated progress milestones. eResearch Technology, Inc. Project Assurance Adverse Events Aris Global complaints, nonconformities, vigilance reporting, product tracking, and more. This easy-to-use and 21 CFR 11–compliant module is fully configurable, scalable, and secure. ARISg The most advanced software for pharmacovigilance and global regulatory compliance, enables the collection, coding, reporting, and analysis of clinical and spontaneous adverse events—from multiple sources, in realtime. A global modular system that can be deployed as a client-server or web-based solution, ARISg is 21 CFR 11–compliant, supports all E2B and MedDRA standards, and is also available as a Japanese, Kanji-based system. ARISg has a multiple of add-on options including: personalized Workflow with built-in Safety Alerts, in-depth Ad Hoc Analysis, Signal Generation and Risk Management with SafetyMART, and the ability to easily interface with other applications (e.g., CDMS, EDC, CTMS, Product Complaints, Drug Registration Tracking systems, etc.). You can also scan, store, and track documents, as well as link directly to Documentum. NetRegulus StudyExpert See Trials Management/Administration Sierra Scientific Software, Inc. Clinical Research Infomation Systemä (CRISä), v7.1 See Trials Management/Administration Winchester Business Systems, Inc. adWATCH-e adWatch helps the clinical trial team track AEs and SAEs as well as product inquiries and complaints from around the world. Integrates seamlessly with Protocol Manager, our clinical trials management system. Automatically generates CIOMS and MEDWATCH 3500 reports for electronic submission. Uses MedDRA and/or user defined dictionaries. Conforms to 21 CFR 11. Assured Information Systems PV-Works PV-Works is the leading workflow-driven pharmacovigilance system. It is 21 CFR 11 compliant, includes MedDRA coding and E2B. The software can inherit your own workflow processes and can be installed on site or run as an outsourced pharmacovigilance service. Assured and PV-Works are able to meet your pharmacovigilance system needs. Carevoyance Telematics Catalyst See Wireless/Mobile Technologies eResearch Technology, Inc. Clinical Project Management BBK Healthcare, Inc. TrialCentralNet TrialCentralNet is BBK’s e-process management system for maximizing site enrollment capability through the creation of relationships with clinical study sites. The comprehensive suite of Web-based tools includes modules specific to sponsors, sites and BBK. Providing ongoing data and communications access in real-time, TrialCentralNet creates a “virtual community” among key parties and maximizes productivity. A full spectrum of consulting and project assurance services that augment the implementation trial execution efforts of clients. The spectrum of services includes study initiation, project management, education, configuration, technology and regulatory review, research dashboards and electronic reporting, uniform standards and standard operating procedures, and migration services. The Company provides on-site research and technology advisory services, support services, and a global customer care 24X7 help desk. Fortress Medical Systems, Inc. Clindex Clindex 2.0 integrates the activities of a clinical department, beginning with database design and methodology, data entry and tracking of CRFs, through the payment of CRFs and study monitoring, to the statistical analysis and archiving of study data. Clindex 2.0 meets all FDA requirements for management and auditing of clinical data. FW Pharma Systems IMPACT See Trials Management/Administration ICTI Interactive Trial Management Solutions ICTI provides interactive trial management solutions using state-of-the-art IVRS development tools. Applications include centralized patient randomization, drug supply management, IVRS-based patient unblinding, patient diary data collection, accelerated patient referral, and automated information distribution. ICTI is the leader in clinical trial material management with the introduction of their powerful forecasting and supply chain management tool. Integic Corporation CRF WorkManager Integic helps life science customers improve drug throughput with technology and services that accelerate research, while controlling costly but necessary compliance issues eSafety Net An Internet-based adverse event management system. This application facilitates compliance by sponsors, clinical research organizations, and investigators with regulatory reporting requirements regarding adverse events and with the sponsor’s or clinical research organization’s own internal requirements for safety data analysis. Sponsors or clinical research organizations can configure this application to match their own processes and forms. ClinLogic ClinProject ClinProject is a Clinical Trials Management application providing real-time insight into study progress. The system provides crucial information for decisions early in the study cycle before CRFs have been retrieved and entered into clinical data management. From site initiation, through grant payment disbursement, ClinProject is an end-to-end solution. MAJARO InfoSystems Inc. ClinAccess Dictionary Coder ClinLogic SAS-powered. Integrates with ClinAccess or as standalone. Works with any dictionary, including MedDRA, COSTART, WHO, or custom built. Autoencodes exact matches. Flexible term search, learning capabilities, entered word as replacement, etc. to assist with uncoded terms. Variety of reports. Used with entire system, images dynamically appear for easy coding. ClinSite See Trials Management/Administration NetRegulus IssueExpert IssueExpert provides all the tools and capabilities necessary for collecting, documenting, tracking, trending, and reporting product quality issues including adverse events, corrective and preventive actions (CAPA), audits, March 2003 ClinSource TrialXS/TMS TrialXS/TMS is the integrated Web-based Trial Management System (CTMS) for your clinical research community. To plan, conduct, and effectively manage clinical trials through experience, collaboration, and consistent workflow. The TrialXS Trial Management System (TMS) addresses the global management aspects of the entire clinical research process. Including process planning, finance and resource management, monitoring tools, and much more. actmagazine.com Check Your Information If you submitted information for the 2003 IT Solutions directory, please carefully examine your listings, and contact us about any problems. If necessary, we will publish an addendum with corrected information in a subsequent ACT issue. Send corrections to IT Solutions Editor Applied Clinical Trials 859 Willamette Street Eugene, OR 97401-6806 fax: (541) 984-5250 e-mail: [email protected] APPLIED CLINICAL TRIALS SUPPLEMENT 25 IT Solutions company directory A–C Acumen Healthcare Solutions, LLC 604-642-2273 fax: 604-642-2293 [email protected] www.carevoyance.com 14252 23rd Ave. North Plymouth, MN 55447, USA 763-559-8232 ext. 23 fax: 765-559-2821 [email protected] www.acumenhealthcare.com Clarinet Systems Advanced Systems Development Clinical DataFax Systems Inc. 2000 Alameda de las Pulgas, Ste. 154 San Mateo, CA 94403, USA 650-292-5300 fax: 650-292-5302 [email protected] www.advasys.com Analyse-it Software, Ltd. P.O. Box 103 Leeds LS27 7WZ, UK +44 113 210 0708 fax: +44 113 229 8424 [email protected] www.analyse-it.com 44040 Fremont Blvd. Fremont, CA 94538, USA 510-249-9661 [email protected] www.clarinetsys.com 25 Main St. West, Ste. 500 Hamilton, ON L8P 1H1, Canada 905-522-3282 fax: 905-522-7284 [email protected] www.datafax.com ClinicalTrialsNet Inc. 12 John St. Charleston, SC 29403, USA 843-965-5598 fax: 843-965-5849 [email protected] www.clinicaltrialsnet.com Clinitrac 2777 Summer Street Stamford, CT 06905, USA 203-588-3000 fax: 203-356-1673 [email protected] www.arisglobal.com St. Eriksgatan 113 Stockholm, S-113 43, Sweden +46 8 5088 0600 fax: +46 8 5088 0609 [email protected] www.clinitrac.com Assured Information Systems ■ ClinLogic Aris Global Equity House, 18 Market Square St. Neots, Cambs PE19 2AF, UK +44 1 480 21 22 23 fax: +44 1 480 21 64 95 [email protected] www.assured.co.uk BBK Healthcare, Inc. 320 Needham St., Ste. 150 Newton, MA 02464, USA 617-630-4477 fax: 617-630-5090 [email protected] www.bbkhealthcare.com Cardio Control Mercuriusweg 1 Delft, 2624 BC, The Netherlands +31 15 750 5000 fax: +31 15 750 5050 [email protected] www.cardiocontrol.com Carevoyance Telematics 1245 W. Broadway, Ste. 300 Vancouver, BC V6H 1G7, Canada 26 18436 Hawthorne Blvd., Ste. 208 Torrance, CA 90504, USA 310-921-6025 fax: 310-921-2835 [email protected] www.clinlogic.com ClinSource Mechelsesteenweg, 455 Bus 2 Kraainem B-1950, Belgium + 32 2 766 00 80 fax: +32 2 766 00 81 [email protected] www.clinsource.com CRF Box Reservoir Place, 1601 Trapelo Rd., Ste. 241 Waltham, MA 2451 781-466-6100 fax: 781-466-6900 [email protected] www.crfbox.com APPLIED CLINICAL TRIALS SUPPLEMENT Cytel Software Corp. 675 Massachusetts Ave. Cambridge, MA 02139, USA 617-661-2011 fax: 617-661-4405 [email protected] www.cytel.com 440-443-0082 fax: 216-921-6702 [email protected] www.datatraknet.com E–F Dynarand D–F DataCeutics, Inc. 1610 Medical Dr., Ste. 300 Pottstown, PA 19464, USA 610-970-2333 fax: 610-970-4884 [email protected] www.dataceutics.com Datafarm Inc. 275 Boston Post Rd., Ste. 2 Marlborough, MA 01752, USA 508-624-6454 fax: 508-624-0848 [email protected] www.datafarminc.com DataLabs 17310 Redhill Ave., Ste. 200 Irvine, CA 92614, USA 949-851-2030 fax: 949-851-2043 [email protected] www.datalabs.com Datapharm Australia Pty. Ltd. 56-56A Thompson St. Drummoyne, NSW 2047, Australia +612 9719 2800 fax: +612 9719 2811 [email protected] www.datapharm.com.au DataSpectrum, Inc. 4700 Falls of Neuse Rd., Ste. 400 Raleigh, NC 27609, USA 800-497-1678 fax: 919-431-9961 [email protected] www.dataspectrum.com DATATRAK Deutschland GmbH Rochusstrasse 65 Bonn 53123, Germany +49 228 979 8320 fax: +49 228 979 9492 [email protected] www.datatraknet.com DATATRAK International, Inc. 6150 Parkland Blvd., Ste. 100 Mayfield Hts, OH 44124, USA actmagazine.com 55 Francisco St., Ste. 780 San Francisco, CA 94133, USA (888)794-IVRS(4877) fax: (415) 362-4525 [email protected] www.dynarand.com ePharmaLearning 625 Ridge Pike, Building E, Ste. 402 Conshohocken, PA 19428, USA 215-643-3318 fax: 215-893-4024 [email protected] www.epharmalearning.com ePocrates, Inc. 1800 Gateway Dr., Ste. 300 San Mateo, CA 94404, USA 650-227-1700 fax: 650-227-2770 [email protected] www.epocrates.com/ trialservices ■ eResearch Technology, Inc. 30 S. 17th St. Philadelphia, PA 19103, USA 866-669-4324 fax: 908-541-0091 [email protected] www.ert.com Fortress Medical Systems, Inc. 901 1st St. North Hopkins, MN 55343, USA 952-238-9010 [email protected] www.fortressmedical.com FW Pharma Systems Four Brindleyplace Birmingham, B1 2JB, UK +44 121 616 5616 fax: +44 121 616 5601 [email protected] www.fwpharma.com G–I Gupta Programming 213 Goldenwood Circle Simi Valley, CA 93065, USA 805-577-8877 fax: 413-383-3543 [email protected] www.GuptaProgramming.com Healthcare Technology Systems, Inc. 7617 Mineral Point Rd., Ste. 300 Madison, WI 53717, USA 800-316-2414 fax: 608-827-2444 [email protected] www.healthtechsys.com Honeywell/POMS 13655 Dulles Technology Dr. Herndon, VA 20171, USA 703-793-4400 fax: 703-793-4401 www.poms.com ICTI 1040 Stony Hill Rd., Ste. 200 Yardley, PA 19067, USA 267-685-4284 fax: 267-685-4262 [email protected] www.icti-usa.com idv Data Analysis & Study Planning Wessobrunner Str. 6 Gauting/Munich 82131, Germany +49 89 850 80 01 fax: +49 89 850 36 66 [email protected] iMedRIS Data Corp. 36213 Highland Ave. Yucaipa, CA 92399, USA 909-520-9164 fax: 909-520-0031 [email protected] www.iMedRIS.com InferMed Limited 25 Bedford Square London WC1B 3HW, UK +44 20 7291 7410 fax: +44 20 7291 7489 [email protected] www.infermed.com InfoPro Solutions 31365 Oak Crest Dr., Ste. 250 Westlake Village, CA 91361, USA 818-879-0075 fax: 818-879-7303 info@infoprosolutions www.infoprosolutions.com Insightful March 2003 1700 Westlake Ave. North, Ste. 500 Seattle, WA 98109, USA 206-283-8802 fax: 206-283-8691 [email protected] www.insightful.com 30 E. 60th St. New York, NY 10022, USA 877-511-4200 fax: 212-813-2102 [email protected] www.medidatasolutions.com Integic Corporation ■ Mini Mitter Co., Inc. 14585 Avion Parkway Chantilly, VA 20151 703-222-2840 www.integic.com IntraLinks, Inc. 1372 Broadway, Floor 11 New York, NY 10018, USA 212-543-7700 fax: 212-543-7801 [email protected] www.intralinks.com invivodata, inc. 5615 Scotts Valley Dr.,Ste. 150 Scotts Valley, CA 95066, USA 831-438-9550 fax: 831-440-1770 [email protected] www.invivodata.com J–N ■ LifeTree Technology 41093 County Center Dr. Temecula, CA 92591, USA 800-211-2799 fax: 877-659-5433 [email protected] www.lifetree-tech.com Liquent, Inc. 1300 Virginia Dr., Ste. 125 Fort Washington, PA 19034, USA 800-515-3777 fax: 215-654-7724 [email protected] www.liquent.com Logos Technologies Ltd. Chiltern House Feathers Yard Basingstoke Hampshire, RG21 7AT, UK +44 1256 478900 fax: +44 1256 473332 [email protected] www.logostechnologies.com ■ MAJARO InfoSystems Inc. 2350 Mission College Blvd., Ste. 700 Santa Clara, CA 95054, USA 408-330-9400 fax: 408-330-9410 [email protected] www.majaro.com ■ Medidata Solutions, Inc. 28 PharmaPros Corporation 245 First St., #1851 Cambridge, MA 02142, USA 978-207-0067 fax: 978-207-0067 [email protected] www.pharmapros.com PharmaTech Solutions, Inc. 20300 Empire Ave., Building B-3 Bend, OR 97701, USA 800-685-2999 fax: 541-322-7277 [email protected] www.minimitter.com 3534 South College Rd., Ste. I Wilmington, NC 28412, USA 888-896-7425 fax: 910-392-7275 [email protected] www.pharmatechsolutions.com Mousley Consulting ■ Phase Forward Incorporated 608 West Main Lansdale, PA 19446, USA 484-433-7300 fax: 215-631-1367 [email protected] www.clinport.com 1440 Main St. Waltham, MA 02451-1623, USA 781-890-7878 fax: 781-890-4848 [email protected] www.phaseforward.com NetRegulus PHT Corporation One Tower Lane, Ste. 1700 Oakbrook Terrace, IL 60181, USA 888-707-6900 fax: 630-573-6050 [email protected] www.netregulus.com 500 Rutherford Ave. Charlestown, MA 02129, USA 617-973-1820 fax: 617-973-1821 [email protected] www.phtcorp.com O–R OmniComm Systems, Inc. 2555 Davie Rd., Ste. 110-B Fort Lauderdale, FL 33317, USA 954-473-1254 fax: 954-473-1256 [email protected] www.omnicomm.com ■ PAREXEL International Corporation 195 West St. Waltham, MA 02451-1163, USA 781-487-9900 fax: 781-487-0525 [email protected] www.parexel.com ■ Perceptive Informatics, Inc. 200 West St. Waltham, MA 02451 781-487-9900 781-434-5916 [email protected] wwwperceptive.com PerMedics, Inc. 1475 South Victoria Court San Bernardino, CA 92408, USA 877-473-7633 fax: 909-478-5016 [email protected] www.permedics.com APPLIED CLINICAL TRIALS SUPPLEMENT ProIRB Plus, Inc. 6020 44th Ave. North St. Petersburg, FL 33709, USA 727-545-5314 fax: 727-541-2433 [email protected] proirb.com Propack Data 2000 Regency Parkway, Ste. 675 Cary, NC 27511, USA 919-465-1741 fax: 919-465-1742 [email protected] www.propack-data.com Relsys International, Inc. 16267 Laguna Canyon Rd. Irvine, CA 92618, USA 949-453-1715 fax: 949-453-1817 [email protected] www.relsys.net S–T SAS Institute Inc. SAS Campus Dr. Cary, NC 27513, USA 800-727-0025 fax: 919-877-4444 www.sas.com/industry/pharma/ drug_dev.html Ste. 150 South Morrisville, NC 27560, USA 919-467-1997 fax: 919-467-1109 [email protected] www.secassociates.com ■ Sierra Scientific Software, Inc. 1325 55th St. Oakland, CA 94608-2609, USA 510-655-2441 fax: 510-217-3519 [email protected] www.sierraware.net Stat-Ease, Inc. 2021 East Hennepin Ave., Ste. 480 Minneapolis, MN 55413, USA 612-378-9449 fax: 612-378-2152 [email protected] www.statease.com StudyBuilder Limited John Eccles House Robert Robinson Ave. The Oxford Science Park, OX4 4GP, UK +44 1865 338 092 fax: +44 1865 338 100 [email protected] www.studybuilder.com U–Z Validation Wizards International P.O. Box 100 West Mystic, CT 06388-0100, USA 860-572-7255 fax: 860-536-9419 [email protected] www.drumkey.com Velos, Inc. 2201 Walnut Ave., Ste. 208 Fremont, CA 94538, USA 510-739-4010 fax: 510-739-4018 [email protected] www.veloseresearch.com ■ Vital Link.net 14450 NE 29th Place, Ste. 108 Bellevue, WA 98007, USA 425-861-5000 fax: 425-861-5099 [email protected] www.vitallink.net SyMetric Sciences, Inc. Vitalograph Inc 1-2082 Sherbrooke West Montreal, QC H3H 1G5, Canada 514-935-4562 fax: 514-935-9911 [email protected] www.SyMetric.ca 8347 Quivira Rd. Lenexa, KS 66215, USA 913-888-4221 fax: 913-888-4259 [email protected] www.vitalograph.com Synteract Vitalograph Ltd. 5759 Fleet St., Ste. 100 Carlsbad, CA 92008, USA 760-268-8200 fax: 760-929-1419 [email protected] www.synteract.com Maids Moreton Buckingham Bucks MK18 1SW, UK +44 1280 827120 fax: +44 1280 823302 [email protected] www.vitalograph.com Systemsmith 18436 Hawthorne Blvd., Ste. 208 Torrance, CA 90504, USA 310-921-2735 fax: 310-921-2835 [email protected] www.systemsmith.com Target Health Inc. SEC Associates, Inc. 261 Madison Ave., 24th Floor New York, NY 10016 , USA 212-681-2100 fax: 212-681-2105 [email protected] www.targethealth.com 3900 Paramount Parkway, TrialTrac, Inc. actmagazine.com 45 Main St., Ste. 405 Brooklyn, NY 11201, USA 718-237-4000 fax: 718-237-4688 [email protected] www.trialtrac.com Wimmer Systems, LLC 3008 Cochise Dr. Independence, MO 64057, USA 816-795-5177 fax: 816-795-5177 [email protected] www.wimmersystems.com Winchester Business Systems, Inc. 304 Cambrige Rd. Woburn, MA 01801, USA 781-503-0200 fax: 781-503-0207 [email protected] www.wbsnet.com March 2003 (professional protocols, process control, data integrity and government regulations). CRF WorkManager automates the core of clinical, therapeutic, or device trial processes using sophisticated document processing and offering access across multiple geographic locations. It electronically distributes work to data reviewers e.g. CRAs, data entry staff, medical writers. It has features to integrate with all major clinical databases and it provides variety of technologies for taking global clinical trial management online. firms. Our combination of clinical trials domain expertise and technical skill makes Systemsmith the best choice for all your pharmaceuticals-related custom software development needs. performed on research subjects in connection with the Company’s customers’ clinical trials. This service permits assessment of the safety of therapies by documenting the occurrence of cardiac electrical charge. Target Health Inc. FW Pharma Systems Target e*CRF See Electronic Data Capture INITIATOR Vital Link.net Multimedia Informed Consent Sessions See Knowledge Management IntraLinks, Inc. IntraLinks IntraLinks connects business communities and accelerates the intelligent flow of information and documents among participants. By using IntraLinks as a drug development hub, pharmaceutical companies can communicate more efficiently with investigators, CROs, IRBs, SMOs, and other parties while speeding clinical trials. IntraLinks digital workspaces are fully hosted and supported 24/7/365, and our service has been found to be 21 CFR 11–compliant. Data Collection/Management Aris Global ARISg See Adverse Events ClinTALK See Wireless/Mobile Technologies Cardio Control ABP Perfect ClinAccess CaseBook See Document Management PC-based Ambulatory Blood Pressure system. Includes management of data. Optional software for digital transmission of data. Clinical DataFax Systems Inc. ProIRB Plus, Inc. DataFax ProIRB ProIRB is a multi-User, multi-IRB software application providing productivity and compliance assurance tools for managing the institutional review board work-flow process from scheduling to meeting minutes. The application is developed in MS Access and is currently in use by major universities and healthcare institutions nationwide. A complete clinical trials management solution using CRFs and simple fax technology at the clinical sites and powerful software at the coordinating center including: intelligent character recognition from faxed CRFs, query tracking, standard reports, audit trails, study setup tool, bookmarked PDFs of patient CRFs, acceptance test kit, and much more. Propack Data ClinicalTrialsNet Inc. PMX(R) CTM Solution ClinTriNet As a result of longtime experience and close cooperation with leading life sciences companies, PMX(R) CTM represents a software suite tailored for the specific demands of pharmaceutical development, clinical manufacturing, and clinical trial management. Our PMX(R) CTM solution is based on the release-controlled PMX(R) applications wellestablished in the pharmaceutical and biotechnology industries. It meets the requirements of the highly sensitive and regulated market of clinical studies and complies with cGMP/GCP guidelines. The process oriented solution, focuses on both efficiency of the application and the safety demands of regulatory authorities. ClinicalTrialsNet has developed a Web-based system that enables comprehensive data, project, and document management in a regulatory compliant, on-line environment. Our intuitive user interface makes it easier for you to focus on trial management, instead of trial software management. Contact us to bring efficient technology to your trials! TrialTrac, Inc. SiteTrac See Trials Management/Administration Winchester Business Systems, Inc. ClinSource TrialXS/CRF See Electronic Data Capture Winchester Business Systems develops software applications for pharmaceutical, biotechnology, and medical device companies designed to improve drug and product development processes. Winchester implements systems for multisite/multivendor clinical trials projects, electronic data collection, workflow management and project management systems, information management, and exception reporting for decision support. Custom Application Development Insightful InferMed Limited MACRO See Electronic Data Capture invivodata, inc. invivosystem invivodata’s electronic patient diary system combines behavioral and clinical science with handheld and Web technology to deliver real-time patient self-report data in clinical trials. invivodata’s science-based diary methods and proven technology optimize patient compliance and study sensitivity to maximize confidence in trial data. Liquent, Inc. Xtent Liquent Xtent is an XML-driven engine that instantly converts information to XML so it can be more widely used and easily distributed. It works by rendering source content to XML while retaining document fidelity, structure, content, and metadata. Liquent Xtent technology increases granularity by breaking content into component parts. TrialXS/PDE Logos Technologies Ltd. TrialXS/PDE offers flexible possibilities to filter the output based on countries, sites, patients, or data status. TrialXS/PDE guarantees highly secured and encrypted data transfer. ALPHADAS See Electronic Data Capture CRF Box CRF Box eDiary Suite See Electronic Data Capture Datapharm Australia Pty. Ltd. eCRF See Electronic Data Capture MAJARO InfoSystems Inc. ClinAccess PowerServer Validated SAS-powered clinical data management software with integrated dictionary autoencoder, data clarification system, workflow, imaging, and Web components. Study setup wizards, automated forms tracking, CRF images received from scan, fax, or file links directly to data for view throughout system. Completely operational within 30 days. Easily customizable by client. DataSpectrum, Inc. Statistical Analysis & Reporting MAJARO InfoSystems Inc. DataSpectrum is an innovative data and statistical services company, providing the ability to use EDC, paper, and fax data collection methods in one study, in one validated system, using Oracle Clinical. This gives you the flexibility to pick a site based on patient enrollment and quality—not the site’s technological ability. ClinAccess Web See Web-Based Software Services Mini Mitter Co., Inc. Actiwatch Actigraphy Monitors See Electronic Data Capture NetRegulus S+SeqTrial S+SeqTrial is an S-PLUS software library for designing, monitoring, and analyzing clinical trials using group sequential methods. The main design focus is choosing the sample size that allows the clinical trial to discriminate between the null and alternative hypotheses, thereby answering the scientific questions of interest. eResearch Technology, Inc. ActivityExpert See Electronic Data Capture eData Management StudyBuilder Design Consultancy See IT Consulting An Internet-based technology for collecting, editing, and managing clinical trial data in any computing environment. Customers use this technology to analyze data, resolve incomplete or erroneous data entries, and support early locking of the database for a particular trial. This product easily integrates with a wide variety of third-party applications for imaging, workflow, and data analysis. Systemsmith eResearch Technology, Inc. Services Systemsmith is a Microsoft Certified Partner EXPeRT focused on custom software development for clinical trials. We have experience developing mission-critical systems for large sites, CROs, and patient recruiting Intelligent, workflow-enabled data handling and distribution of paper-based and digital ECG data and images as well as analysis and cardiologist interpretation of ECGs APPLIED CLINICAL TRIALS SUPPLEMENT Clinical IVR Systems See Electronic Data Capture ClinSource Custom application development 30 Expedite and standardize new development based on prebuilt and validated best practices clinical trial reporting templates. Reuse and customize best practices templates to individual clinical trial studies. Ideal environment for leveraging and reusing existing SAS code. Ensure compliance by using best practices SOP and validation documentation for IQ and OQ requirements. Healthcare Technology Systems, Inc. Clinport See Trials Management/Administration StudyBuilder Limited Gupta Programming Best Practices Clinical Trial Reporting Templates Aris Global MAJARO InfoSystems Inc. Mousley Consulting INITIATOR is a complete solution for improving productivity and access to both operational and planning data in the Phase 1 arena. Using electronic data capture techniques, INITIATOR provides fast access to real-time, quality assured data. And the system automates many laborintensive tasks to ensure that studies are conducted cost effectively. actmagazine.com NetRegulus RegistryExpert RegistryExpert allows users to link and track products, patients, care facilities, capital equipment, medical professionals, and more. Register and track capital equipment and products by product number, serial/lot number, date, or your own system. Features multiple address capability to quickly locate patients with products in critical situations. PerMedics, Inc. Encaptor EDC System Encaptor enables data managers obtain trial data in real March 2003 time from anywhere in the world. Complex case report forms with validation and edit checks are designed easily using design templates. The XML based system is 21 CFR 11–compliant with audit trail and multi-level security features. PerMedics’ software suite includes trial management solutions. PharmaPros Corporation NetRegulus ReportExpert ReportExpert provides detailed, Web-enabled internal analytical reporting for decision makers, as well as regulatory reporting for all phases of a product’s life cycle. Includes a library of standard reports and intuitive tools to create unlimited ad hoc reports, charts, and graphs. Generates and emails regularly scheduled reports. DataVal See Other Applications PharmaPros Corporation Data Warehousing NCompass NCompass is a comprehensive clinical systems environment that provides Clintrial, Clintrace, CRFTrack, DataVal and other 3rd party products as an integrated web-based solution. NCompass includes all the software, services, and technical support needed to run clinical trials. comprehensive audit trails. If you need a system to accommodate off-line and/or on-line data entry without changing your database, TracIt2k can do it affordably. Cardio Control Recollect ECG event recorder system for acquisition of high-resolution ECG data. System can record up to 180 minutes of data, 1 or 2 channels. Clinical DataFax Systems Inc. DataFax See Data Collection/Management Liquent, Inc. Clinitrac IDRAC Clinitrac Patient Diary, Clintrac Visit Diary Wireless patient diary that enables collection and monitoring of patient data in real-time. See Training IDRAC is a global regulatory intelligence database that helps to accelerate your product’s entrance into the worldwide marketplace by delivering highly focused information on ever-changing requirements. It brings together all the information you need to stay up-to-date on regulatory requirements in 30 countries. SyMetric Sciences, Inc. Vital Link.net SyMetric Clinical Data Management system Vital Source See Data Collection/Management StudyBuilder Limited Complete Introduction to StudyBuilder Training Course Comprehensive data management system for clinical trials including full support for double data entry, multivariate data validation, data dictionary, autoencoders for all standard dictionaries (ICD9, MedDRA, WHO, etc.), query management, flexible export to ASCII, HTML, and SAS, etc. Complies with all regulatory requirements. For more information, please visit our Web site. Document Management Aris Global REGISTER See Knowledge Management Synteract IntraLinks, Inc. SynCoder IntraLinks See Clinical Project Management SynCoder is an SAS application that implements the MedDRA terminology, as well as COSTART and WHO-DRUG dictionaries, for coding adverse event and medication text reported during clinical trials or post-marketing. The product requires SAS v8.1 or higher, and works with SAS v6 or v8 databases. TrialTrac, Inc. TrialWorks TrialWorks is clinical trials management software designed for sponsors and CROs. It's easy to use, quick to implement, customizable, and 21 CFR 11 compliant. Our integrated design is comprehensive, and tracking includes investigator payments and earnings, patient information, essential documents, clinical supply inventory, and every step in between. TrialWorks is also available through our e-Service-we are your ASP. Vital Link.net Vital Source The Vital Source clinical data management system (CDMS) is a flexible and secure data repository. Its intuitive format ensures that any user, regardless of computer skill level, can set up an effective study database, collect and export data into a statistical analysis tool, and quickly generate study reports. Vitalograph Ltd. Spirotrac Centralized Spirometry System See Electronic Data Capture Wimmer Systems, LLC DaCS (Data Compliance System) DaCS is the original stand-alone 21 CFR 11 compliance solution for Microsoft Excel, providing security, audit trails, and true electronic signatures in a low-cost, low-overhead, and customizable solution. Free demonstration software allows you to conduct a full evaluation before purchasing. Data Mining/Visualization ClinSource Insightful Miner Insightful Miner Desktop Edition is the first affordable, nocompromise data mining workbench that gives new data miners and skilled modelers the ability to deploy predictive intelligence throughout the enterprise. March 2003 TrialXS/CRF TrialXS/CRF is a Web-enabled CRF design tool to create, design, program, and change Clinical Research Forms in a fast, accurate, remote, and secure environment. It works fully integrated with the TrialXS trial management and data capture system. CRF Box CRF Box eDiary Suite Electronic Patient Diary solution to collect primary and secondary efficacy data from all patient populations. Incorporating PDA handheld devices and mobile phones using worldwide communications technology, pharma companies are able to collect high-quality data reliably on a global scale. Trial visibility and control is provided through online role based portal and reporting technology. Liquent, Inc. CoreDossier DataLabs CoreDossier lets you easily and efficiently manage multiple, simultaneous report and submission dossiers. The backbone of this product suite is its unparalleled PDFrendering technology, which ensures that exact page fidelity is maintained at all times. With a single, cohesive interface, it works with no modification on most document management systems. DataLabs CTMS See Clinical Project Management Liquent, Inc. CoreReports CoreReports is Liquent's browser-based publishing solution designed specifically for organizations that use Documentum and want to extend publishing capabilities to multiple departments. By using CoreReports to ensure that your documentation––from R&D through clinical trials ––is properly formatted, you gain a significant head start in producing and submitting high-quality dossiers. MAJARO InfoSystems Inc. ClinAccess CaseBook An imaging component, designed to take advantage of full integration with our PowerServer product. Receives images from fax, scan or file format making this “case book oriented” imaging system very flexible. Recently we added OCR (optical character recognition) capabilities for use in situations where appropriate. Integration with PowerServer not only eliminates duplicity of efforts and simplifies validation, it keeps the image tied to the data at all times. Combined with a group of management tools for annotating forms, multiple view, and search tools, workflow capabilities make this component revolutionary in clinical data management. Datapharm Australia Pty. Ltd. eCRF eCRF is a remote data capture tool allowing sites to enter clinical data offline at the site and send clinical trial data electronically to Datapharm’s secure server. Fields are programmed with edit checks and database lookups allowing quick access to clean data which can be viewed on the Web. System setup and maintenance is cost effective. DataSpectrum, Inc. Oracle Clinical RDC See Data Collection/Management DATATRAK Deutschland GmbH/ DATATRAK International, Inc. DATATRAK EDC DATATRAK International, Inc., with offices in Cleveland, OH, and Bonn, Germany, specializes in electronic data capture using DATATRAK EDC. The product suite operates in centralized or stand-alone modes, and offers state-ofthe-art security and real-time data entry and review. Electronic site assessment, Web-based training offered. Dynarand Electronic Diaries Dynarand's Interactive Voice Response (IVR) and Webbased Electronic Diaries are a convenient, user-friendly means of collecting patient data and improving patient compliance. They provide an economic alternative to other diary collection methods. ePocrates, Inc. Winchester Business Systems, Inc. Honors Trial Feasibility Research See Trials Manage- Health Agency Tracking ment/Administration The Health Agency Tracking system tracks all documents associated with queries and responses made by and to regulatory agencies. Automatic workflow notifies all interested parties and initiates action items for resolution of the query. Maintains complete audit trail. Conforms to 21 CFR 11 regulations for electonic records and signatures. TrialXS/PDE See Data Collection/Management Insightful ClinSource Electronic Data Capture eResearch Technology, Inc. eData Entry An electronic data capture (EDC) system permitting investigators to use standard Internet browser tools to input data into a centralized database in an online or offline environment. eData Entry accommodates traditional manual, paper-based data entry, data entry using the Internet and other forms of electronic data transmission. eData Entry can also capture data in the form of electronic images. Acumen Healthcare Solutions, LLC TracIt2k EDC System Healthcare Technology Systems, Inc. TracIt2k is the most affordable and flexible EDC solution available today. Quickly and easily create, design and modify your own e-CRFs complete with error checks and Clinical IVR Systems Led by three distinguished medical professionals, Healthcare Technology Systems (HTS) is the world leader in actmagazine.com APPLIED CLINICAL TRIALS SUPPLEMENT 31 developing and delivering clinical IVR systems to gather data directly from patients. HTS offers more than 30 IVR clinical rating scales, including the HAMD and the McGill Pain Questionnaire, plus research and clinical expertise. PHT Corporation StudyBuilder Limited LogPad StudyBuilder Enterprise Server See Web-Based Software Electronic patient diary Services StudyBuilder Limited InferMed Limited StudyBuilder Enterprise Edition MACRO StudyBuilder Enterprise Edition ($4999/study designer; no site/subject/data manager fees) Integrated study design, data management, and collection software package. Use wizards and drag-and-drop to design and deploy your study. Includes data collection/management system for Web, palmtop, and desktop computers and integrates data from spirometers, etc. automatically. MACRO is InferMed’s electronic data collection solution for clinical trials. MACRO is an easy-to-use system that can guide you smoothly through the transition from paper to electronic clinical data capture systems. MACRO has intuitive, interactive tools for study definition, on-line and off-line remote data entry and study monitoring. MACRO is the only independent EDC system fully integrated with Oracle Clinical. Target Health Inc. Target e*CRF LifeTree Technology ICTM, ILMS LifeTree Technology is a proven performer with the vision, capabilities and resources expected in a web-based EDC partner. LifeTree’s ICTM is uniquely easy to learn, deploy and maintain. Our web-based Double Data Entry eases the transition from paper to EDC. ILMS is a 21 CFR 11–compliant laboratory sample inventory management system. With comprehensive ASP services, 24/7 support and independently confirmed compliance, LifeTree Technology is leading the transition from paper to EDC. Logos Technologies Ltd. ALPHADAS Logos Technologies is a global provider of System Solutions for Drug Research to the world’s Pharmaceutical and Clinical Research Organisations. Our market leading products, ALPHADAS and Smart Patient Diary Card have successfully improved our clients study efficiency, provided compliant data, achieved a faster database closure, as well as dramatically reducing cost. Logos Technologies prides itself on its high-quality solutions which meet GCP & FDA regulatory compliance such as 21 CFR 11. e*CRF is a proprietary Internet-based remote data entry, data management, and project management system, created and managed exclusively by Target Health Inc. Data are entered through a Web interface (browser) directly to a remote database. No software is installed and the system is fully functional even if used with a 28.8 modem. The system is validated and 21 CFR 11–compliant. An NDA was recently approved which used the system. The FDA site audit was flawless. Advanced Systems Development Clinical IT systems implementation consulting Implementation and integration consulting services for Oracle Clinical, TMS, AERS, and other IT clinical systems. DataCeutics, Inc. IT Support and Services for the Clinical Research Environment DataCeutics is the leader in Clinical Information Technology. DataCeutics offers products and services from three business lines: Clinical Systems Services (CSS), Clinical Reporting Services (CRS), and Computer Systems Compliance Services (CSCS). DataCeutics performs turnkey implementations of the leading clinical data management systems, comprehensive validation services, SAS Programming, and clinical reporting solutions Datafarm Inc. Vital Link.net Clinical Information Technology Consulting See Vital Tracker Electronic Submissions The Vital Tracker application is a powerful yet easy-to-use electronic data capture system. Through key features such as automated edit checks, Vital Tracker saves time and improves the validity and integrity of the study data. The system is available either Web-based or through the Vital Link solution for clinical trials. eResearch Technology, Inc. Project Assurance See Clinical Project Management InfoPro Solutions Clinicopia Suite See Trials Management/Administration Vitalograph Inc StudyBuilder Limited Electronic PEF/FEV1 Diary system StudyBuilder Design Consultancy As above for data transfer or via mobile phone direct from patients’ homes. StudyBuilder Design Consultancy ($599 per hour on-site, $299 per hour off-site). Outsource study design and implementation based on StudyBuilder products to our consultants including protocol and paper case report form design (includes layout, development of validation criteria, documentation and testing). Typical project requires between 40 and 160 hours of consultancy. Vitalograph Ltd. Medidata Solutions, Inc. Spirotrac Centralized Spirometry System Medidata RAVE Vitalograph has been a world leader in respiratory diagnostics for almost 40 years. The Centralized Spirometry System transmits encrypted data everyday via email from investigator sites direct to the sponsor or via a dedicated and unique over-read software system where data quality is ensured on a daily basis. Alternatively, the clinic software can be interfaced with an Internet EDC system for data exchange. Medidata RAVE offers an integrated suite of clinical trial solutions including Electronic Data Capture, study and site management, and patient diaries. Our “zero client” application is quick to learn, easy to use. You select hardware, software, and connectivity; as long as you can access the web, your trials commence with split-second page turns. IT Consulting Systemsmith Services See Custom Application Development Knowledge Management Mini Mitter Co., Inc. Actiwatch Actigraphy Monitors Actiwatches are wrist-worn, 17.5-g medical devices for monitoring subject activity and analyzing sleep and circadian rhythm patterns. Used for supplementing patient diaries with objective data, verifying subject compliance with trials protocol, and tracking treatment efficacy. Actiwatch-Score includes an LED touchpad for patient input of subjective rating on pain levels, anxiety, etc. NetRegulus ActivityAnywhere See Wireless/Mobile Technologies NetRegulus ActivityExpert ActivityExpert is an entirely Web-based solution that enables any authorized person to input information into NetRegulus’ PQIntelligence Software System. This product is ideal for vendors, field representatives, auditors, clinical trial personnel, and others who require limited access to the system’s functionality. OmniComm Systems, Inc. TrialMaster OmniComm Systems provides Web-based applications for the collection and primary validation of clinical trial data. Our applications include electronic CRFs, patient enrollment tracking, randomization, email communication, reporting, trial management, and more. Electronic Submissions Aris Global E2B Gateway Designed as a stand-alone, secure, user-friendly webbased application, E2B Gateway comes with built-in Cyclone Interchange software, can connect to any pharmacovigilance system, and facilitates the transfer and management of compliant E2B files to global and local regulatory authorities. And with E2B Gateway, companies can easily exchange critical safety information with global trading partners Datafarm Inc. Clinical Information Technology Consulting Datafarm provides electronic document publishing, clinical data management, statistical analysis and reporting, document management systems, and custom application development solutions. Functionally, Datafarm solutions maximize the quality of publishing and efficiency of document life-cycle management. MAJARO InfoSystems Inc. APPLIED CLINICAL TRIALS SUPPLEMENT The most comprehensive global drug registration and tracking system. Compliant with the latest regulatory guidelines, REGISTER provides for reliable and accurate product information (e.g., preferred name, ingredients, International birth date, registration renewals formulations, approval status, registration number, etc), global monitoring of activities, and compliance for manufacturing and QC regulations. eResearch Technology, Inc. eResearch Community A central command and control portal that provides realtime information related to monitoring clinical trial activities, data collection, and safety. This Internet-based tool, which includes research dashboard and health education modules, allows participants in the clinical trial to follow the progress and conduct of a study based on frequently updated data using the Internet. The participant can analyze data and generate reports in a broad variety of formats that permit early strategic intervention in the clinical trial. Insightful ment InFact SAS Drug Development See Knowledge Management Encaptor EDC System See Data Collection/Management 32 REGISTER ClinAccess PowerServer See Data Collection/Manage- SAS Institute Inc. PerMedics, Inc. Aris Global actmagazine.com InFact is currently the only commercial technology of its kind to embody human-like intelligence, thereby empowering knowledge workers and decision-makers to make better decisions faster in a wide range of critical, highvalue business areas. March 2003 MAJARO InfoSystems Inc. Stat-Ease, Inc. ClinAccess Dictionary Coder See Adverse Events Design-Ease Software NetRegulus PQIntelligence PQIntelligence is a 21 CFR 11–compliant software suite that provides enterprise-wide, Web-enabled data management specifically for the medical products industry. Working in the background, PQIntelligence organizes, automates, and manages clinical, regulatory, and other product quality data, while you focus on what you do best —developing and marketing your product. distribute supplies, manage the financial aspects of a trial, and electronically view clinical trial data on the Internet. Design-Ease is an entry-level program for design and analysis of two-level and general factorial screening experiments. Detect main effects and interactions that lead to breakthrough improvements. In addition, the software handles any number of categorical factors at any number of levels, thus offering extreme flexibility for most screening needs. Training SAS Institute Inc. SAS Drug Development ePharmaLearning By streamlining research activities, providing centralized web-based data access, automating processes for complying with government regulations and industry standards, and offering core data transformation, analysis, and exploration tools, SAS Drug Development provides the intelligence needed to make more informed clinical and business decisions, ultimately bringing drugs to market more quickly and efficiently. eMeetings, eLearning See Web-Based Software Services Vital Link.net Validation Wizards International Multimedia Informed Consent Sessions Validation Wizard for Application User Teams Multimedia consent sessions improve adherence to clinical trial protocols and significantly increase patient retention within the trial. These sessions use 3-D animations, text, and exam questions to educate subjects and verify their understanding. Multilingual presentation and content written at a 6–8th grade level guarantees subjects can easily understand the information. Validation Wizard for Application User Teams is a “read and click” application that trains the trainer and the user team in the ABCs of computerized system validation (CSV) for user acceptance of regulated systems. Wizard teaches a common-sense approach for integrating CSV into the normal workflow of regulated areas. StudyBuilder Limited FW Pharma Systems IMPACT IMPACT is the market leader in Clinical Trials Management Software. It is designed to assist pharmaceutical companies, CROs, device manufacturers, and biotech companies in managing research activities—ranging in scale from single site to large multinational, multi site studies, and from first use in man to single or multi-country marketing studies. IMPACT will give you total flexibility in the level of detail tracked, while maintaining complete consistency across the user base. Most importantly, IMPACT’s vision is to support what people do in their day-to-day jobs and help them make decisions based on the latest enrollment, payment and milestone information across countries and sites. Complete Introduction to StudyBuilder Training Course Complete Introduction to StudyBuilder Training Course ($499/CD-ROM, DVD, video). An interactive multimedia guide to using StudyBuilder tools for study design, data collection and management. FW Pharma Systems INITIATOR See Data Collection/Management Honeywell/POMS POMS CMS Statistical Analysis Trials Management/Administration Manufacturing execution systems for clinical supplies manufacturing. idv Data Analysis & Study Planning Rancode Plus 3.6 Program for randomizing trial subjects according to the permuted block scheme with constant or varying block size. It prepares random code lists, sealed envelopes, and stick-on labels. Rancode Professional comes with many facilities for working in a validated environment according to GCP and FDA regulations. Partial decoding possible according to a predefined subject list. System(s): DOS/Windows 98/2000/NT/XP/ME. Aris Global Analyse-it Software, Ltd. globalTRIALS iMedRIS Data Corp. Analyse-it Clinical Laboratory iRIS (internet Research Information System) See Web- Analyse-it! Method evaluation software for Microsoft Excel. Includes NCCLS and IFCC protocols, Altman-Bland and NCCLS bias-plots, Deming, Passing-Bablok and Kappa method comparisons, NCCLS EP5 imprecision, NCCLS EP6 linearity, IFCC reference ranges, ROC curves, and sensitivity and specificity analysis. Visit our Web site to download a free 30-day trial. A comprehensive web-based clinical trials project management system (CTMS) for the collection, management, sharing, analysis, and reporting of study performance data. With remote data entry support via a standard web browser, globalTRIALS enhances study set-up, project management, study-metrics, and tracking, study subject enrollment, supplies tracking, adverse event tracking, electronic document exchange, and tracking, etc. Cytel Software Corp. ClinLogic East ClinProject See Clinical Project Management Software: The industry standard solution for design, interim monitoring and simulation of flexible clinical trials. With East, you can make better decisions sooner about your trials, stop futile studies early, easily design and simulate sequential studies and pick the best study design for your needs, and bring drugs to market sooner. DataSpectrum, Inc. Statistical Analysis & Reporting See Data Based Software Services InfoPro Solutions Clinicopia Suite The Clinicopia Suite is the world’s first purpose-built, industry-specific clinical trials supplies management system developed from the ground up to meet the unique needs and concerns of all the groups associated with clinical trial materials supply. The Suite consists of Clinicopia Supply Chain, Clinicopia Drug Accountability, Clinicopia Process Execution, Clinicopia Labeling, and Clinicopia Forecasting. ClinLogic ClinSite is a comprehensive solution for SMOs and research sites, managing all aspects of clinical trial participation from prospecting and enrollment to grant payments and patient stipends. The system tracks visits and procedures and can enforce protocol visit windows. ClinSite also includes call center management, media effectiveness, and medical records. Collection/Management Mousley Consulting Clinport ClinPort is an Internet portal for clinical study management. It integrates all departments and clinical systems of your company into one efficient trial management tool providing immediate cost savings with a modest investment. Clinport applications include Clin Binder, Clin Safety, IVRS, Clin Reports, Trial Supply, and Clin Contacts. ClinSource Gupta Programming TrialXS/TMS See Clinical Project Management Data Collection/Management Datapharm Australia Pty. Ltd. SMART See Clinical Project Management idv Data Analysis & Study Planning Nnpar 1.0 DataSpectrum, Inc. Program for planning and interpreting sample size and related topics within the framework of the Wilcoxon-MannWhitney test. Target parameters include sample size, alpha, beta, and the smallest detectable difference expressed as Mann-Whitney statistic. It supports tests for difference and tests for equivalence/non-inferiority, onesided and two-sided. System(s): DOS/Windows 98/2000/NT/XP/ME. Statistical Analysis & Reporting See Data Collection/Management S-PLUS S-PLUS is the premier solution for exploratory data analysis and statistical modeling. With over 4,200 data analysis functions, including the most comprehensive set of robust and modern methods available anywhere, S-PLUS allows you to perform more insightful analyses, create revealing graphics and make more informed business decisions. MAJARO InfoSystems Inc. ClinAccess SureStart See Data Collection/Management March 2003 StudyExpert streamlines the management of clinical trial and other study data, while complying with the FDA’s Guidance for Industry: Computerized Systems Used in Clinical Trials and 21 CFR 11. Features intuitive tools to enter, track, verify, query, view, and export case report from data as well as input and oversee key management information. ePocrates, Inc. DocAlert(r) Messaging See Wireless/Mobile PerMedics, Inc. Technologies Surveyor Trial Management System ePocrates, Inc. Honors Trial Feasibility Research Insightful NetRegulus StudyExpert Best Practices Clinical Trial Reporting Templates See Using our ePocrates Honors, connect with over 77,000 verified physicians to learn about the likelihood of being able to recruit certain patient types as well as the feasibility of other aspects of your clinical trial protocol. ePocrates will program, host, and collect your feedback data using an online survey system. Surveyor is a software application designed for single and multisite clinical trials management. Surveyor tracks trial progress including enrollments, patient status, resource management, financials, and IRB activity. Patient tracking tools include automated scheduling, screening, adverse events and visit completion reports. The Web-based software aids HIPAA compliance and simplifies trial management with unlimited reporting capability. PerMedics’ software suite includes data capture solutions and services. eResearch Technology, Inc. eStudy Conduct PharmaTech Solutions, Inc. An Internet-based technology to set up clinical trials, establish standards, track study activities, plan resources, Patient Recruitment, Interactive Voice Response Systems, Outcomes Research Implementation Support, Consumer Affairs Support See Other Applications actmagazine.com APPLIED CLINICAL TRIALS SUPPLEMENT 33 Propack Data Web-Based Software Services PMX(R) CTM Solution See Clinical Project Management Wireless/Mobile Technology Sierra Scientific Software, Inc. Acumen Healthcare Solutions, LLC Aris Global Clinical Research Infomation Systemä (CRISä), v7.1 TracIt2k EDC System See Electronic Data Capture ClinTALK Aris Global globalTRIALS See Trials Management/Administration Enables companies to easily connect to other disparate systems (e.g., CDMS, safety, financial, and other systems) in order to share critical information in real-time. ClinicalTrialsNet Inc. Carevoyance Telematics ClinTriNet See Data Collection/Management Catalyst The Clinical Research Information Systemä (CRISä), v7.1 provides a fully integrated, fully interactive application that captures, archives, and reports data across the entire clinical enterprise. Supporting electronic or manual entry and export of data, CRIS incorporates CDM, CTMS, materials management, and safety data management and accelerated reporting functions Dynarand TrialTrac, Inc. Integrated Study Management SiteTrac Dynrand's Interactive Voice Response (IVR) and Web-based Systems provide integration of real-time data to simplify project management, reduce human error, and save time and money. Automated notifications and summary reports provide the additional tools that make the systems an optimal solution for study management. SiteTrac is clinical trials management software tailored to the needs of SMOs, research institutions, sites, and AROs. It’s easy to use, quick to implement, customizable and HIPAA compliant. Our integrated design is comprehensive, and tracking includes patient information, essential documents, investigator earnings and sponsor payments, patient/study searching, and every step in between. Velos eResearch Velos eResearch is a transformational trial management solution that supports investigators, study teams and sponsors through the entire research process—including protocol design, patient feasibility assessment, study administration, project management and trial execution— thus expediting the research process, enhancing quality and improving access to data by integrating systems, aggregating information and centralizing processes. Validation Interactive Investigators’ Meetings, online meetings, eLearning, and eCollaboration solutions for clinical research professionals delivered by clinical research professionals. iMedRIS Data Corp. iMedRis has designed a Web-based trials management system that integrates with our Web-based IRB application. Submissions, AEs, and updates all flow seamlessly between each of the modules thus cutting time and paperwork for all. Sites also have ability to capture and export data using our new Data Capture module. ICTM, ILMS See Electronic Data Capture Clinical IT systems implementation consulting See IT MAJARO InfoSystems Inc. Consulting ClinAccess Web PV-Works See Adverse Events Coming this year, data entered via Web directly into SAS datasets. Uses PDF, with online validation. Serves data back (available dynamically as entered) for review, reporting. Data clarification processing, including query resolution and tracking, with dynamic access to images. Easily combine data from Web, OCR, and/or in-house entry. DataCeutics, Inc. Medidata Solutions, Inc. IT Support and Services for the Clinical Research Environment See IT Consulting Medidata 4sight Analyse-it Software, Ltd. Analyse-it Clinical Laboratory See Statistical Analysis Assured Information Systems The EthIR LAN family brings PDA and laptop users the immediate benefits of dedicated high speed network access using popular software applications such as AvantGo, web clippings, Eudora web browsing, E*Trade stock transaction, email access, etc. Installation of the EthIR LAN into a 10/100 Base-T or 802.11b backbone for network access is seamless due to its internal DHCP functionality. iRIS (internet Research Information System) LifeTree Technology Advanced Systems Development Clarinet Systems EthIR LAN ePharmaLearning eMeetings, eLearning Velos, Inc. Using handheld PDAs, our turn-key solutions prompt subjects to report data in real-time, while continuously monitoring for adverse events and assuring trial protocol adherence. Better quality data, reduced time to database lock, and safe management of adverse events results in expedited trials significantly reduced risk for our customers and their subjects. Clinitrac Clinitrac Patient Diary, Clintrac Visit Diary See Electronic Data Capture ePocrates, Inc. DocAlert(r) Messaging ePocrates DocAlert(r) messaging program allows the pharmaceutical industry a unique, effective method of communicating their recruitment needs direct-to-physicians. The messaging program works on a handheld device platform and allows for bi-directional communication. ePocrates is able to target your trial recruitment message by physician specialty and geographic location. invivodata, inc. invivosystem See Data Collection/Management Logos Technologies Ltd. SMART Patient Diary Card Honeywell/POMS POMS CMS See Trials Management/Administration Relsys International, Inc. Argus Safety Relsys International is the leading developer of specialized software for managing product risk associated with pharmaceuticals and medical devices. The company’s software solutions empower manufacturers to meet current product safety regulations and internal quality objectives. Argus Safety is the world’s top-selling global drug safety software solution. Medidata 4sight joins the core technology philosophy of Medidata’s clinical research products with opportunities for online communications packages for post-approval trials and registries. Online newsletters, surveys, forums, and downloadable or linked content (such as white papers, webcasts, and other resources) are prebuilt and ready for rapid branding and deployment with trial-specific content. Logos Technologies is a global provider of System Solutions for Drug Research to the world’s Pharmaceutical and Clinical Research Organisations. Our market leading products, ALPHADAS and Smart Patient Diary Card have successfully improved our clients study efficiency, provided compliant data, achieved a faster database closure, as well as dramatically reducing cost. Logos Technologies prides itself on its’ high quality solutions which meet GCP & FDA regulatory compliance such as 21 CFR 11. Medidata Solutions, Inc. NetRegulus Medidata RAVE See Electronic Data Capture ActivityAnywhere OmniComm Systems, Inc. TrialMaster See Electronic Data Capture PerMedics, Inc. SEC Associates, Inc. Surveyor Trial Management System See Trials Manage- Computer system compliance consulting ment/Administration SEC Associates provides system compliance consulting and computer validation services for the pharmaceutical, biotechnology, and medical device industries. SEC’s experienced consultants assist clients with regulatory compliance assessments, vendor audits, 21 CFR 11 training, procedure development, requirements analysis and planning, documentation, and execution of computer validation and life cycle activities. StudyBuilder Limited Inside StudyBuilder See Training ActivityAnywhere is a supplemental module to our ActivityExpert data collection and workflow management tool. It allows users to record data using intuitive forms right at a field, clinical trial, or manufacturing site using portable devices such as Windows-based PC tablets or laptops. PHT Corporation LogPad See Electronic Data Capture PharmaPros Corporation NCompass See Data Collection/Management StudyBuilder Limited StudyBuilder Limited Capture StudyBuilder Enterprise Edition See Electronic Data MyStudyBuilder.com MyStudyBuilder.com ($4999 per quarter) MyStudyBuilder.com is the one stop data hosting service for studies designed with StudyBuilder software. Locate at MyStudyBuilder.com and your study will have a private Web site built and deployed on dedicated servers within a few hours. Vitalograph Inc Electronic PEF/FEV1 Diary system See Electronic Data Capture Other Applications Winchester Business Systems, Inc. ComPac GxP Velos, Inc. ComPac GxP software from Winchester Business Systems is the only complete 21 CFR 11 solution for Lotus Notes and Domino. It allows an organization to make its existing or future Notes Based applications 100% compliant with 11 regulations. ComPac GxP bolts on to the existing applications with minimal disturbance to the original code. Velos eResearch See Trials Management/Administration 34 APPLIED CLINICAL TRIALS SUPPLEMENT Vital Link.net Vital Tracker See Electronic Data Capture actmagazine.com Clarinet Systems EthIR LAN See Wireless/Mobile Technologies Dynarand Electronic Diaries See Electronic Data Capture March 2003 Dynarand Integrated Study Management See Web-Based Software Services PharmaPros Corporation CRFTrack See Data Collection/Management PharmaPros Corporation DataVal DataVal is a suite of flexible, validated, easy-to-use PL/SQL programs for use in the design and development of edit checks. Using DataVal can significantly reduce the effort in the development and testing of edit checks, and increase consistency across studies for discrepancy management. DataVal is integrated with Phase Forward’s Clintrial 4. PharmaTech Solutions, Inc. Patient Recruitment, Interactive Voice Response Systems, Outcomes Research Implementation Support, Consumer Affairs Support PharmaTech Solutions is a Patient Management Organization (PMO) serving the pharmaceutical and healthcare industry. We pride ourselves on focusing on the patient in clinical and commercialization programs. We provide services that accelerate enrollment of thoroughly qualified patients and maximize patient compliance and retention. Our clinical and marketing experts understand disease states, the challenges of enrolling a clinical trial, the importance of collaboration with investigator sites and our responsibility in educating and communicating with patients. SEC Associates, Inc. Computer system compliance consulting See Validation Wimmer Systems, LLC DaCS (Data Compliance System) See Data Collection/Management March 2003 actmagazine.com APPLIED CLINICAL TRIALS SUPPLEMENT 35
