Regulatory Expertise

Led by tenured senior executives with extensive clinical research experience, Bioclinica's global cardiac safety and efficacy regulatory expertise is second to none. Bioclinica's unmatched regulatory leadership is well recognized and backed by ongoing professional relationships with key authorities and panels. We have worked with the ICH and FDA to advance industry standards and guidance in the conduct of TQT 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'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

Industry Associations

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)
  • ICH-E14 expert advisory panel
  • American Society of Hypertension (ASH)
  • American Telemedicine Association (ATA)