Medical Safety Support

Criterion Edge can offer innovative solutions for ensuring patient safety in for your clinical trials

Patient safety is always the highest priority during development of any investigational product. For any sponsor, safety monitoring responsibilities begin from investigational plan development and continue through the life of the product. Our medically experienced safety monitors can partner with, or act on behalf of sponsors to provide medical oversight at any stage of your trial.

Talk to us about what other tasks that we can assist you in the safety monitoring process.

Key deliverables may include:

  • Develop a comprehensive safety plan based on best practices and specific needs for your trial
  • Provide expert advice on safety-related study documents:
    • Safety section of the protocols
    • AE/SAE case report form design
  • Informed consent form
  • Develop study-specific clinical safety training materials for your investigative sites and/or in-house personnel
  • Provide individual and aggregate reviews of AEs and SAEs for trending, assessment of seriousness and causality, and identification of potential endpoint events
  • Respond to safety-related inquiries from regulatory authorities
  • Author clinical event narratives
  • Support all types of endpoint adjudication process, including the use of external committees, single physician adjudicator, and even internal adjudicators
  • Support DSMB process

Generis American Medical Device Summit 2019

Oct 28-29, in Chicago, IL

Join our President Laurie Mitchell at the AMD summit as she leads a session on day 2: Systematic Literature Review: How to Empower Data-Driven Decision Making.

Interested in discussing regulatory or medical writing projects? Book a free consultation with President Laurie Mitchell and CEO Lalitha Jonnavithula at booth #13, where you can sign up for the chance to win a FREE Amazon Echo!