Harrison Clinical Research and XClinical Sign Agreement on EDC System XTrial.WASHINGTON & MUNICH, Germany -- Harrison Clinical Research announces cooperation with XClinical, in a non-exclusive agreement to promote and use its electronic date capture (EDC EDC See: Export Development Corp. ) system XTrial, in clinical trials worldwide. Speaking at the DIA meeting in Washington, Dr. Francisco Harrison, Chairman of the international CRO Harrison Clinical Research (HCR HCR High Commissioner for Refugees (UN) HCR Home Condition Report HCR Health Care Reform HCR Highway Contract Route (US Postal Service) HCR High Consistency Rubber HCR Human Cognitive Reliability ) said, "We are excited that XTrial - the most user friendly EDC system designed by investigators for investigators - is already being endorsed by so many cardiologists in the IKKF network." Dr. Philippe Verplancke, President of XClinical went on to explain, "XTrial was developed in Germany, with the cooperation of the Institute for Clinical Cardiovascular Research (IKKF). XTrial is an integrated electronic data capture (EDC), clinical data management (CDM 1. CDM - Content Data Model 2. CDM - Code Division Multiplexing ) and clinical trial management (CTM) system. It is one of the first to be fully based on CDISC CDISC Clinical Data Interchange Standards Consortium standards and is fully GCP and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. compliant, especially FDA guideline 21CFR CFR See: Cost and Freight 11". More than 11,000 patients in 19 simultaneous trials have already been documented with the Internet-based XTrial system, accessible from any browser. Dr. Verplancke added, "This non-exclusive agreement with HCR is a tremendous opportunity to demonstrate and promote XTrial in HCR clinical trials worldwide. It was designed with the most modern technology, medical professionals endorse it, it allows seamless data exchange with regulatory authorities and it is affordable. XClinical is pleased that the international CRO Harrison Clinical Research, one of the first CROs to obtain the ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001 qualification in 1998, has chosen our system." The key points of the agreement between HCR and XClinical are that HCR will: --Use XTrial as its own EDC system for early phase I and IIa clinical studies in its Munich clinical unit. --Recommend XTrial to all its Phase II and III clients who have not yet finalised their choice of EDC system. Dr. Harrison summed up by saying, "HCR chose XTrial because we are the medically driven CRO: this system was developed by medical professionals and is the most investigator-friendly system ever devised. We are looking forward use and promote this excellent solution within our client and investigator networks worldwide." |
|
||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion