New EDC Partnerships Unveiled at Industry Conference

July 18, 2006

Several new products and partnerships in the field of electronic data capture (EDC) were unveiled at the Drug Industry Association’s (DIA) annual conference in Philadelphia in June.

Medidata Solutions, New York, and Cytel, Cambridge, Mass., announced a partnership offering sponsors the ability to directly randomize patients in all types of trials, both traditional and adaptive, through an EDC system.

This is done by integrating Cytel’s FlexRandomizer “engine” into Medidata’s web-based EDC system, Rave. The combined software enables a trial monitor to see what arm of the trial any given subject is in and make changes if necessary, while the investigator “sees the stratum the subject is in but not which arm” so that randomization is maintained, Glen de Vries, Medidata’s chief technology officer, told PIR.

Hybrid trials often end up having to do double data entry, but “our product is single instance,” de Vries said. “A lot of EDC companies have every single trial for a given customer in a separate database. We think you should do like people used to do with CDMS [clinical data management systems] — put everything in one database. This helps guide the data manager or doctor or nurse through all the trials the company is doing.”

This approach combined with Rave’s “deep security model” and web-based, site-centric approach have helped Medidata achieve “triple-digit growth year over year,” de Vries said.

Data-Mining Tool Merges With AERS

Another software partnership announced at the DIA conference is the integration of DrugLogic’s Qscan data-mining analytical tool for drug safety into Oracle’s Adverse Event Reporting System (AERS), which tracks adverse events through the internet and patient and physician reports.

AERS is part of a suite of applications Oracle offers for monitoring, reporting on and analyzing clinical trials, Dennis Constantinou, senior director of industry strategy and marketing for the life sciences, told PIR.

“Now we can take the capability of DrugLogic for signal detection and its unique algorithms and apply it to the data,” he said. This enables epidemiologists, biostatisticians and other experts “to spend time reading the report” on adverse events and drawing the relevant conclusions, rather than doing the drudge-work of preliminary data analysis.

One company that makes use of Oracle’s EDC system is i3 Statprobe, Ann Arbor, Mich. “We have bought it and customized it for our own use,” Marianne Plaunt, vice president of global data management, told PIR.

She explained that the company is a data services contract research organization that helps sponsors with data management support and training. The company can work with EDC products other than Oracle’s, and can help a sponsor decide if paper case reporting forms are preferable to EDC for a particular trial. That may be the case if, for example, the trial coordinators are visiting the sites so infrequently that learning a new EDC system is an inefficient use of their time.

New EDC Product

OmniComm Systems, Fort Lauderdale, Fla., used the DIA conference to introduce the latest version of its main EDC product, TrialMaster 4.0, which is available at three different levels of service for clients under the company’s “application service provider” business model.

For the smallest trial sponsors, OmniComm can set up the entire EDC system and host, validate and maintain the database on its own servers, all in real time, according to Terry Wolf, regional vice president of business development. Medium-sized clients might prefer to build the protocol and validate the database, while OmniComm hosts and maintains the database. The largest sponsors can put TrialMaster and the entire trial database on their own in-house servers and configure the software to their own needs. — Martin Gidron