Clinical Trial Management Software (CTMS)

End-to-end Clinical Trial Management Software (CTMS)—long sought as the “holy grail” of fast and successful product development—is streaming into the life sciences marketplace.

As the central hub of all information and management in a clinical trial, CTMS offers potential for data sharing, transparent communication, and cost-effective streamlining of clinical development operations. In some vendor offerings, CTMS enables managing multiple trials at once.

Best-of-Breed vendors offer a single, comprehensive software system that pulls together electronic data collection (EDC), a Clinical Data Management System (CDMS), an Adverse Event Reporting System (AERS), as well as Interactive Voice Response Systems (IVRS), plus reporting and statistical analysis. It may be more than what buyers need currently – but would address many needs now and in the future.

Best-in-Class Clinical Trial Management Software Features:

• Enables comfortable transition from paper-based, legacy clinical trial methods to all-electronic, Internet-enabled solutions.
• Offers a CTMS architecture that scales not only for enterprise growth but also to accommodate multiple trials.
• Provides a comprehensive solution capable of managing information and processes from EDC, CDMS, adverse event reporting systems, and IVRS, etc.

Top Considerations before Buying Clinical Trial Management Software:

A CTMS investment needs to be scalable, comprehensive, and upgrade ready. That’s a must, especially in an industry undergoing consolidation yet, at the same time, projected by the likes of Software Insider to exceed $1.5B in software and services revenue by 2012. As a result, pricing is expected to be more favorable with pre-2012 vendor offerings. 
 
Key Products:

1. IMPACT and TrialWorks are two CTMS solutions from Perceptive Informatics. IMPACT offers a feature-rich, deep, and highly adaptive management solution, while TrialWorks is a better match for newly-emerging biotechnology, pharmaceutical and life sciences companies where  rapid implementation and low cost of ownership are priorities. Perceptive Informatics, Inc. offers electronic data capture, medical imaging, clinical trial management systems; interactive voice and Web response systems, eClinical systems integration and implementation, and electronic patient reported outcomes services. A subsidiary of Parexel International Corp., Perceptive Informatics, Inc. serves pharmaceutical, biotechnology, and medical device companies. Perceptive Informatics, Inc. holds leadership positions in both enterprise CTMS with its IMPACT product and TrialWorks, its CTMS solution for its medium-size user base, the latter growing at a 25% annual rate.

2. Clintrial, an automated, integrated software solution from Phase Forward Inc., provides CDMS, together with CTMS to manage the entire clinical development process from study initiation and FDA submission through to post-marketing studies. Paul Bleicher, MD, with a vision to develop technology to transform paper-based clinical trial management methods into Internet-enabled solutions, founded Phase Forward in 1997, which, in turn, developed Clintrial, an integrated suite of software that can automate the management of the entire clinical development process—from study setup through regulatory submission and post-approval trials. For handling the complete life cycle of clinical trials, Phase Forward’s CTMS platform has handled 10,000 trial implement-tations, and among its 335 customers counts industry giants like Merck, Genzyme and Novartis. Oracle, lacking a strong CTMS component for its Oracle Health Sciences group, purchased Phase Forward in April of 2010.

3. StudyManager SE with Integrated CTMS from StudyManager includes site and overall aggregate study progress tracked with user-defined indicators, subject visit logs, eCRF and AE submissions, user-customizable key performance indicators, build monitor schedules; and generate, sign, and submit monitor trip reports electronically. By providing clinical data collection, study management, and real-time interaction among study administrators, study monitors, and site users in one package. Previously established as a dominant developer in clinical research for health systems, academic medical centers and research sites, StudyManager SE, which was an initial CDMS offering, is, with the addition Integrated CTMS, the company’s first strategic CTMS move into sponsor-side research.

4. Office-Smart Clinical Trial Manager from BioClinica, Inc. leverages the Microsoft Office environment with Clinical Trial Process Manager (CTPM) offers a transition for bringing standard Microsoft Office tools, business process workflow, and documents into the regulated world of clinical trial management. After 17 years in the medical imaging management field (1990-2007) as Bio-Imaging Technologies, and after the acquisition of Phoenix Data Systems, the company rebranded itself in 2008 as BioClinica and moved into the e-clinical arena. In March of 2010, BioClinica acquired Transcenda International LLC and its CTMS offering, the Office-Smart Clinical Trial Manager suite of web-based, Office-Smart CTMS solutions, as well as certain other patent-pending integration technologies.

5. Developed to address suboptimal performance in relationship management in many CTMS product offerings is the Siebel Clinical Trial Management System from Oracle’s Health Sciences group. Built on Siebel System’s pioneering Customer Resource Management (CRM) paradigm (Oracle acquired Siebel Systems in 2005), Oracle’s approach to CTMS focuses on strengthening relationships with clinical trial participants, especially investigators and subjects, by using CRM software solutions.

Clinical Trial Management Software
Definition: Clinical Trial Management System (CTMS) maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones. Used by pharmaceutical and life sciences companies to manage the large amounts of data involved with the operation of a clinical trial. CTMS helps to identify key performance indicators, establishing metrics, results, and performance management.