Overland Park, Kansas - Vince & Associates Clinical Research announced today its membership into the Cardiac Safety Research Consortium (CSRC). As a member of the CSRC, Vince & Associates will participate with industry leaders on key issues that impact cardiovascular safety, including alternative approaches to ICH E14 for the assessment of arrhythmia liability in early drug development.
The CSRC was initiated in 2006 as part of an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.
The CSRC supports research by enlisting stakeholders from industry, academia and government to share data and expertise. Outputs of the CSRC will include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs and consensus white papers.
Vince & Associates' 15 years of early development expertise has recently been coupled with the ECG core expertise provided by another CSRC partner, iCardiac, Inc. iCardiac's innovative technology platform allows for the highly powered analysis of FIH studies utilizing early cardiac monitoring to provide statistically powered cardiac analysis, potentially alleviating the requirement for a thorough QTc (TQT) study. As a result, Vince & Associates Clinical Research is well positioned to support the needs of clients looking to incorporate TQT assessment into their early phase clinical studies.
Dr. Brad Vince, CEO and Medical Director at Vince & Associates stated, "As part of this initiative, we are establishing a stakeholder position in the area of cardiovascular evaluation which will allow Vince & Associates to help shape the future of cardiac safety in drug development."
About Vince & Associates Clinical Research
Vince & Associates Clinical Research has provided clinical research services to the biopharmaceutical industry for 15 years. The research professionals at Vince & Associates are proud to be recognized in the industry as a "Center of Research Excellence."
Vince & Associates currently operates a state-of-the-art, multimillion-dollar, 100 bed clinical pharmacology unit that combines the ultimate in subject safety and luxury. This early development unit has the upscale atmosphere necessary for the recruitment and retention of study volunteers in both short and long-term clinical trials. From the safety and security of the controlled access unit to the added features of a movie theater and game rooms, no detail has been overlooked.
Altasciences is the parent company of wholly owned subsidiaries Vince & Associates Clinical Research (Kansas, USA) and Algorithme Pharma (Quebec, Canada and North Dakota, USA). Both organizations provide comprehensive early stage clinical services in Phase I/IIa, including the necessary support services in this critical stage of drug development.
Additional background materials pertaining to Vince & Associates Clinical Research are located on the corporate website at www.vinceandassociates.com.
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