PERC assists Industry and not-for-profit organizations in the development of innovative clinical trial design, assuring that regulatory and/or funding authorities are clear on the overall concept. Our goal is to create a protocol that makes scientific rationale central to the field of study, and serves to broaden the overall knowledge base.

With over 10 years of protocol development experience, we have successfully designed trials to serve both US and European markets.

Trial Design and Protocol Components Include:

• Background Information and Scientific Rationale
• Product Risks/Benefits
• Study Objectives
• Study Design
• Study Population:
  • Inclusion/Exclusion Criteria
  • Recruitment Strategies
• Study Procedure/Evaluations
• Assessment of Safety, Adverse Events, and Protocol Deviations
• Clinical Monitoring Structure
• Statistical Considerations
• Data Handling and Record Keeping
• Core Lab/Sub Study Assessments
• Relevant and Up-to-Date References
• Initial Case Report Form Development and/or Review (See Data Management)