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Protocol De-Risking

Protocol De-Risking 2016-11-16T18:35:22+00:00

Process – Risk – Management

The success of any clinical trial is defined in the planning phase. The clinical trial is a complex process, which incorporates a number of internal (e.g. safety, protocol compliance, financial) and external (e.g. political, cultural) risks. Each risk has it own importance for a company and therefore must be analysed locally in the context where a clinical trial takes place.

The Risk Defense Strategy, which Cyntegrity creates for its customers, can be compared as a house around the primary research outcome:
Risk Defense Strategy

In order to de-risk a protocol of a trial Cyntegrity offers the following services:

Before clinical trial:

  • Risk analysis of the clinical Protocol (evaluation how risky the protocol is)
  • Definition of “Design space”
  • Finding the suitable Key Risk Indicators (KRIs)
  • Elaboration of Risk Defense Strategy
  • Writing of Monitoring plan and Risk-based Monitoring (RbM) plan

During clinical trial:

  • Automatic monitoring of such risks as:
    • protocol violation,
    • protocol amendment,
    • technical defects of EDC Software,
    • fraud,
    • misconduct of devices,
    • wrong calibration,
    • poor patient recruiting
  • Adjustment of the risks’ weights
  • Configuration and development of the new KRIs

After Clinical Trial:

  • Risk Management Study Report
  • Retrospective analysis of a clinical trial
  • Summing up the “Lessons learned” from the risk management

Interested in learning more about Cyntegrity and our services?

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