Scientific & Regulatory Expertise
Led by tenured senior executives with extensive clinical research experience, Bioclinica’s global cardiac safety and efficacy regulatory expertise is well respected in the industry. We have worked with the ICH and FDA to advance industry standards and guidance in the conduct of thorough and intensive QT studies and have successfully completed the first ever regulatory mandated TQT studies in both Japan and China. Bioclinica has supported the design and specific cardiac monitoring technology for our sponsors on studies requested by regulatory authorities. The data from such studies has met the predefined goals established by both sponsor and regulatory organizations. Bioclinica has been integral in the advancement of implementation of blood pressure monitoring as both an efficacy and safety endpoint in drug development. Our participation in the cardiac safety research consortium and discussions with regulatory, clinical and industry leadership has supported initiatives in the drug development process.
Bioclinica’s regulatory services include:
- Protocol consultation and guidance throughout development life cycle
- Fast-tracked ECG and imaging data regulatory submissions and archiving
- Audit preparation and support
- FDA ECG warehouse submission
- Integrated Cardiac Safety Summary reports in support of the alternative approach to formal TQT study requirements
Bioclinica continues to accelerate drug development, working in tandem with regulatory bodies and key clinical research associations to establish and maintain core lab industry standards for cardiac safety services.
Our contributions include interaction with the following:
- Metrics Champion Consortium (MCC)
- Cardiac Safety Research Consortium (CSRC)
- International CardioOncology Society (ICOS)
- American Society of Hypertension (ASH)
- American Telemedicine Association (ATA)