In CPU, Phase 1 Clinical Trials, White Paper

Have your Phase 1 studies received proper risk mitigation planning?

Phase 1 studiesEven in Phase 1 clinical studies conducted with healthy volunteers, there are a number of potential risks which can be detrimental to the overall success of your study.  While most Phase 1 units are likely to have Standard Operating Procedures which provide guidance on how to respond to emergencies or adverse events during a study, few sites are likely to develop Risk Mitigation Plans that are tailored to address specific protocols.

Sponsors and their sites should be working together collaboratively to develop comprehensive Risk Mitigation Plans for all Phase 1 studies they conduct. By creating a Risk Mitigation Plan, stakeholders are able to produce a documented, systematic approach to identifying potential risks before the trial has begun.

In this white paper, you will learn:

  • Where potential risks can be identified within the protocol
  • What factors outside of the protocol should be considered when determining potential risks
  • What items to include in order to produce an organized, user-friendly Risk Mitigation Plan

After reviewing this white paper, you and your team should be able to develop a Risk Mitigation Plan which includes:

  • Classifications and implications of identified risks
  • Steps for mitigating risks
  • Courses of action to be followed in the event a pre-identified risk does occur, also known as Contingency Planning

Additionally, through this document, you will find helpful examples of potential risks that could easily occur in Phase 1 studies without proper planning, as well as a sample of a Risk Mitigation Plan which you can use to model your own plans around in the future.

WCCT Global is a full-service early phase contract research organization (CRO) for the pharmaceutical, biotechnology and medical device industries. Since 1998, WCCT has participated in over 1,000 trials, with extensive experience in Phase 1 clinical trials, including first-in-human (FIH), SAD/MAD, PK/PD, BA/BE, and devices.  We are an industry-leader in conducting Japanese Ethnobridging trials at our corporate-owned Phase 1 Unit in Cypress, CA.


White paper on creating a Risk Mitigation Plan for Phase 1 clinical trials.

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