New Members:
- Bayer
- Bioclinica
- Boehringer Ingelheim
- Bristol Myers Squibb
- Celerion
- CytoVas
- Portola
- Vince and Associates Clinical Research
Collaborative Relationships
- American College of Cardiology (ACC)
- Drug Information Association (DIA)
- ILSI Health and Environment Scientific Institute (HESI)
- International CardiOncology Society (ICOS)
- Consortium for Innovation and Quality in Pharmaceutical Development (IQ)
- Safety Pharmacology Society (SPS)
White Papers Submitted to American Heart Journal
- Novel Oral Anticoagulants (NOAC) and Reversal Agents: Considerations for Clinical Development – Troy Sarich, PhD, Submitted
- “Considerations for Assessing the Potential Effects of Antidiabetes Drugs on Cardiac Ventricular Repolarization: A Report from the Cardiac Safety Research Consortium” – Ingrid Hensley, PhD
- “Centralized Adjudication of Cardiovascular Endpoints in Cardiovascular and Non-cardiovascular Pharmacologic Trials: A Report from the Cardiac Safety Research Consortium ” – Jonathan Seltzer MD, MBA
- “Cardiovascular Safety Outcome Trials: A Meeting Report from the Cardiac Safety Research Consortium” – Philip Sager, MD
- CSRC White paper: Can the Thorough QT/QTc study be replaced by ‘Early QT assessment’ in routine clinical pharmacology studies?—Borje Darpo, MD
Expert Panel Papers: DIA Publications
- CSRC White paper: Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes- Mary Jane Geiger, MD
Summary Reports of Thinktanks
Thinktank Meetings
- Outcomes Thinktank- February 2014
- COPD Thinktank Meeting- March 2014
- NOAC Reversal Thinktank Meeting- April 2014
- CIPA Update Workshop CSRC/HESI/SPS/FDA Meeting- December 2014
- Can QT Assessment in Early Clinical Development be used to Replace the TQT Study- Presenting Results from the Prospective IQ-CSRC Clinical Study- December 2014
- NOAC Reversal Agent Thinktank Follow-Up: Post Approval Safety and Effectiveness- February 2015
Projects
- CRF Forms for Non Cardiovascular Clinical Trials
- CSRC/IQ Clinical Trial