By Deb Borfitz
December 14, 2009 | Economy-driven pressures to improve clinical trial efficiency, coupled with the growing need for electronic data capture (EDC), is giving a noteworthy boost to companies offering a clinical trial management system (CTMS) designed specifically for research sites, including those running as few as three studies concurrently. The newfound demand is a direct result of ongoing patient recruitment challenges, increased sponsor focus on costs and timelines, expanding trial complexity, and inefficient data management processes, says Maria Durkin, vice president and director of marketing and operations at Rochester, NY-based Bio-Optronics.
Currently, about 600 sites of every size and variety are using Clinical Conductor, the CTMS launched by Bio-Optronics two years ago. That’s up from 400 earlier this year, notes Durkin. “More sites have been proactively coming to us for answers… [to] help them recruit faster, run trials more effectively, reduce costs, and be more marketable to sponsors.”
Plano, Tex-based ClinTrial Works started selling its site-specific ClinTrial Works CTMS in September and president Angela Germany reports it has been “well-received by the industry.” Current clients consist of small and moderate sized sites, which has been the target.
With thousands of sites in the U.S. still relying on paper and pen or an Excel spreadsheet to manage trials, they’ll be no shortage of would-be customers for either company in the months ahead. For 15 years, StudyManager and Clinasyst were virtually the only players offering sites an information technology (IT) alternative.
CTMS allows sites to leverage data about protocols and patients, within a single site or across multiple ones, from one centralized location, says Durkin. Among the unique features of Clinical Conductor is the ability to quickly identify potential study subjects within an existing patient database, develop simple or detailed online pre-screening questionnaires, and manage the “complete enterprise workflow.” The system captures metrics to help sites market themselves to sponsors, automatically schedule patient visits per the protocol, and manage their finances. Clinical Conductor is integrated with QuickBooks, allowing sites to automate payment of patient stipends or any of their other financial obligations.
Twenty-five years of experience in health care, workflow, and IT differentiates Bio-Optronics as a company, and that expertise was used collaboratively with research sites to develop Clinical Conductor, says Durkin. Customer support is available 24/7 and web-based training is offered throughout the year, all at no extra charge. New releases come out multiple times a year and enhancements are driven by customer requests and evolving market needs. The latest version includes a project management module for milestone tracking.
Future editions of Clinical Conductor are expected to integrate with more enterprise IT systems inclusive of EDC as well as electronic medical record and health information systems. “New offerings will continue to improve collaboration across research boundaries,” Durkin says. Recent enhancements, including a physician portal for information sharing, and improved financial management tools, have piqued the interest of more academic sites.
Germany personally developed ClinTrial Works to give sites, including her own (Professional Research Network of Kansas), a more efficient way to self-manage. It’s purposefully designed to be “real flat and basic” and is priced to be financially feasible for small and newly established sites, she says. Rather than the more typical per-study fee, ClinTrial Works charges a flat monthly subscription fee—discounted 50% for sites doing fewer than ten studies annually—plus a single, upfront fee for unlimited training. At least some of that cost may be recouped directly from sponsors, who often allow a “technology fee” to be worked into study budgets.
Although Germany plans to “take it slow” to ensure site support for ClinTrial Works is top-notch, she’s still shooting to have at least 250 sites using the system by the end of 2010 “because it’s so user friendly.” Training, typically done online, takes no more than 90 minutes.