eShowcase

March 1, 2004

Applied Clinical Trials

Medidata Solutions's Vision Developer, Gentiae Clinical Research, Inc.'s LifeSignals, and Integic Corp.'s CRF WorkManager

Vision Developer

Medidata Solutions' newest addition to its Rave suite of programs allows for ad-hoc real-time query reporting

Medidata Solutions (New York, NY) offers an advantage for the clinical trial world similar to a recent moviemaking technology innovation. In Hollywood, post-production work can now start in the middle of filming instead of only afterwards. In a CRO, that means the ability to fully utilize data when it comes in during a trial, not after.

Its new Vision Developer system is an ad-hoc query, reporting, and analysis solution. Anyone who can get on the Web can access the database: no hardware required. It allows metric and clinical data to be combined, and allows sponsors to customize their data queries using countless approaches. Data warehouse searches utilizing the entire database are no more difficult than finding out how many people are enrolled at a particular site. Each search can be represented in graph or table form, too, for easier analysis. Since it can run queries with whatever data has been inputted, it can reveal fixable red flags during the trial instead of after. This, Medidata notes, can significantly increase study efficiency.

The data mining potential is designed for big jobs, but smaller jobs will be able to appreciate the data-manipulation. Vision Developer is an optional part of the company's Rave suite of programs.

LifeSignals

Gentiae Clinical Research, a new Bay Area CRO, also has a side business making software for cardiac labs

Gentiae Clinical Research, Inc. (San Francisco, CA) is creating satellite businesses to serve its main occupation as a CRO. Its new LifeSignals System is at the center of its cardiac core labs side-project.

LifeSignals is able to take data from 100 ECGs and, less than a half-hour later (near-real time), offer up usable information to the client. The system has automated a lot of manual processes that previously took days or weeks to accomplish. By offering its information on the Web, it allows PIs and sponsors access to their information within minutes from any online computer. And special triggers will notify all involved if an adverse event is recorded.

Gentiae is a for-profit spinoff of the nonprofit Ischemia Research and Education Foundation, and its unusual name, picked by President Michael Kokesh, means "people of the world" in Latin. Next up for the company is a diagnostic imaging system, to store cath lab, nuclear lab, MRI and CT images for viewing over a secure Web portal. It should be available in a month or two, part of Gentiae's umbrella plan for CRO services.

CRF WorkManager

The standard for converting data, Integic's CRF WorkManager makes clinical trials more efficient

Integic Corp. (Chantilly, VA) specializes in speeding up workflow of industries by putting all relevant information in one easy-to-access place. For clinical trials, the company has developed CRF WorkManager.

CRF WorkManager is able to take a CRO's data in all its various forms and make it accessible in one format: an Oracle Clinical database. Printed docu-ments can be scanned into the online database, and a new feature allows for offline scanning as well. Faxes are entered through a similar process. Elec-tronic information from other programs can be cleaned up for importation. New data can be entered directly into the mix. That data can then be used for mining or warehousing purposes.

Integic claims this can dramatically cut time off the clinical trial cycle.