XClinical Expands its Services to the United States

XClinical GmbH, Munich, Germany – March 10, 2008 – 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.

Maureen Lyden, CEO of BSI, said: “We were excited and surprised about the user-friendliness of MARVIN which empowered us to configure the whole study, independently without any help of XClinical’s technical personnel, within our deadline. Our sponsor already had very good experiences with XClinical’s product in the past, and we found the developer interface to be extremely intuitive and easy for our programmers to use, including writing complex edits and actions. Independently of this study we will offer MARVIN to our clients throughout the US as part of XClinical’s “Fellowship Program”.

Dr. Lindenau, Head of Business Development at XClinical, stated: “We are very pleased about our global expansion, after our latest move to Japan we are now on the way to strengthen our presence in the United States, the country with the largest pharma market worldwide. This is a significant win for our Company and it substantiates the value that customers are beginning to see in our user-friendly and flexible EDC system being able to supply high quality and reliable data throughout the entire clinical trial process. MARVIN empowered BSI to design its clinical trial using our Tech Transfer program without any further help from our service team.”

XClinical and BSI are also very pleased to announce that they will exhibit together at the next DIA Data Management in Washington which takes place in March 2008. Please visit us at booths # 605 and 603.

About XClinical

XClinical GmbH (www.xclinical.com), an innovative EDC-CDM system vendor based in Munich, Paris and Boston, USA, provides solutions for the electronic conduct of all types of clinical trials, post-marketing studies and registries.
XClinical develops and markets MARVIN, a CDISC ODM certified online platform for Electronic Data Capture (EDC), Clinical Data Management (CDM) and Clinical Trial Management (CTM). Till today, MARVIN was used to collect and process data of more than 50,000 patients in 50+ studies.

About BioStat International

BioStat International, Inc., is a contract research organization whose goal and purpose is to provide outstanding biostatistics, data management and clinical management services, by dedicating its energy and talents with quality, personal attention, support, commitment, and cost effectiveness to its clients.

Simone Hoerrlein, XClinical GmbH, Tel.: +49 (0)89 / 45 22 77 – 52 30,
Email: press@xclinical.com