MUNICH, Germany--(BUSINESS WIRE)--XClinical, a European vendor of innovative software products for e-clinical trials, today reported that BioStat International Inc. (BSI), a contract research organization (CRO) headquartered in Tampa, FL, USA, will soon begin a very unique medical device study. BSI was trained at the end of October 2007 on behalf of a global industry leader. The comprehensive training session on MARVIN, XClinical’s innovative EDC system, empowered the CRO in less than 12 weeks to set-up the clinical trial independently without the assistance of XClinical’s technical personnel. The ability to become independent in design and implementation of a clinical trial in a very short time period was an important reason for choosing MARVIN. Specific functionalities that were important in the selection of MARVIN in addition to traditional electronic data capture included “Patients as Users” to directly collect Patient Reported Outcome as part of the trial design, “Double Data Entry” capability which allows the conduct of hybrid studies through simultaneous EDC and DDE, and, finally, integration of binary data collected via the diagnostic measuring devices used in the study. XClinical will also be responsible for hosting services and managing the data transfer from the measuring devices to the study database.
