QRM, Oversight and Compliance Management

pharma consulting quality risk management

Implementation of Quality Risk Management (QRM) into clinical development procedures is requested by regulatory authorities.
With the second revision of ICH-GCP in 2017 the general concept of risk-based planning and control of clinical trials has become mandatory, and it has again been reinforced in ICH-GCP (R3). The updated guideline emphasizes

  • The „Quality by Design“ approach: prospective attention to the design of all components of the protocol, procedures, associated operational plans and training.
  • The requirement for the assessment and management of critical to quality factors impacting participant’s rights, safety or the reliability of trial results.
  • The proportionality approach: clinical trial processes and risk mitigation strategies should be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.

A sound risk evaluation and the identification of trial- or program-specific critical to quality factors during the planning phase, and proper management of the identified risks and factors during the entire trial or program lifecycle, are key to a cost- and time-efficient conduct. It further increases the probability that trials will meet their objectives, thereby also increasing the probability of success for the entire development program.
The emphasis on risk-proportionate approaches goes hand in hand with an increased demand for appropriate oversight and compliance management. Oversight by the sponsor includes Quality Management and Quality Control processes for the trial-related activities of investigators and service providers, e.g.,

  • determination of trial-specific criteria for classifying protocol deviations as important.
  • processes to identify, report and manage noncompliances with the protocol, SOPs, GCP and/or applicable regulatory requirements.

These demands require a sound oversight concept which is reflected in the protocol, internal oversight and risk management standards, vendor contracts and project-specific plans.

I will support your QRM, compliance and oversight management by offering services like:

  • Assuming the role of a Head of QM, Quality Manager or Compliance Manager.
  • Development of SOPs and integration into the Quality Management System.
  • Development, implementation and execution of

    • QRM concepts/plans for clinical trials and development projects.
    • Vendor qualification and oversight strategies/plans for clinical trials and development projects.
    • Establishment of compliance management processes on company level.