Medical Affairs And Pharmacovigilance

The Clinical Science and Safety Department (CSS) bridges the gap between academia and industry providing scientific and medical thought leadership to clinical development programs including endpoint selection, clinical study designs, trial conduct, clinical data interpretation, and regulatory submissions.

Comprised of clinical research scientists, medical writers and medical safety officers the CSS team provides day-to-day medical and scientific oversight for Phase I-IV clinical trials.

The CSS team also provides critical methodological input into CPC's endpoint quality assurance efforts, which focus upon reducing endpoint variability via the Endpoint Quality Intervention Program (EQuIP).
CSS services include:

• Development of:
  • Protocols
  • IND/IDE submissions
  • Investigator's Brochures
  • Clinical Study Reports
  • Manuscripts, abstracts, posters, and oral presentations
• Medical Monitoring
• Regulatory reporting of:
  • Adverse Event (AE)
  • Serious Adverse Event (SAE)
  • Unanticipated Adverse Reaction (UAR)
• Management, formation, and participation of/on:
  • Clinical Endpoint/Adjudication Committees
  • Data Safety Monitoring Boards
  • Steering Committees
  • Entry Review Committees

Therapeutic Expertise

The CSS Department has a depth of clinical and clinical research experience in a wide array of therapeutic indications. As a direct affiliate of the University of Colorado School of Medicine, the CSS Department regularly draws upon field-leading expertise across the spectrum of indications, scientific fields, and medical subspecialties, leveraging the strength of the academic campus of the University of Colorado for the benefit of drug/device development programs. For a frequently-updated listing of CPC's individual areas of therapeutic expertise and field-leading therapeutic experts, please click here.