Quality Risk Management / Oversight Management

Implementation of Quality Risk Management (QRM) into clinical development procedures is requested by regulatory authorities.
The EMA reflection paper from 2013 defines QRM as “a systematic process for the assessment, control, communication and review of risks associated with the planning and conduct of clinical trials and clinical development programs.”
With the second revision of ICH-GCP in 2017 this general concept of risk-based planning and control of clinical studies has become mandatory.
Also in 2017 the EMA expert group on clinical trials has issued a recommendation paper for risk proportionate approaches in clinical trials running under the CTR 536/2014, emphasizing that the Regulation supports a risk management approach which is commensurate with the design and conduct of a clinical study, and with the IMP status.
This means that a sound risk evaluation commencing even before the trial protocol has been finalized may save time and effort during trial conduct.

The emphasis of risk-based approaches by regulators goes hand in hand with an increased demand for appropriate vendor oversight measures.
Every company that outsources operational tasks needs to implement processes which ensure that services conducted on their behalf are in compliance with applicable laws, guidelines and company standards.
This requires a sound oversight concept which is reflected in internal oversight and risk management standards, vendor contracts and project-specific plans.

CHPC can help with your QRM and oversight management by offering the following services:

• Development, implementation and execution of
  
  
  • QRM concepts/plans for clinical studies and development projects
  • Vendor oversight strategies/plans for clinical studies and development projects
• Development of pertaining SOPs and integration into the Quality Management System