Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

The CSRC was launched in 2006 through an FDA Critical Path Initiative Memorandum of Understanding with Duke University to support research into the evaluation of cardiac safety of medical products.

CSRC supports research by enlisting stakeholders from industry, academia and government to share data and expertise. Outputs of the CSRC include research projects taking advantage of waveforms released from the FDA ECG warehouse, Think Tank Incubator programs and consensus white papers. Additional work is under way to expand the portfolio of research projects beyond the ECG data into other areas of cardiac safety evaluation from the preclinical through the postmarket periods.