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CASE STUDY: ENSURING REGULATORY COMPLIANCE | ICH E6 (R2) Addendum | Optimizing Quality Risk Management | TayganPoint Consulting Group

CASE STUDY: ENSURING REGULATORY COMPLIANCE | ICH E6 (R2) Addendum | Optimizing Quality Risk Management


The recently revised ICH E6 (R2) Addendum provides both a challenge and opportunity for GCP organizations to modernize their QRM approaches. 

By building quality in – starting with critical data & processes during  protocol development, using centralized and study risk-based monitoring, strengthening risk mitigation – organizations can better manage risks resulting in increased clinical and operational data quality, speed of decision making, and patient safety.

Our client, a global Biopharma company, needed to quickly come up to speed to both ensure compliance and optimize value, by implementing new QRM practices and supporting tools, in an efficient and effective manner.


TayganPoint assembled a team of domain experts (Clinical Operations, ICH, RBM), program, and change management professionals to assess the current state compliance and areas of opportunity for improvement.

Working with a cross-functional Sponsor team, recommendations and detailed designs were developed around Process Improvements and Enabling Tools, SOP Development, Training and Communication.

An implementation plan allowing for Fit-For-Purpose solution development and rollout to the client’s Americas, Europe, and Asia-Pac regions was developed.


Implementation included:

  • Developing new ways of working with Investigators and CROs in overseeing quality.
  • Leveraging Industry Standards and Tools to Optimize existing Quality Management Systems and Processes for Human Subject Protection, Trial Results Reliability, and Operational Efficiencies.
  • Adopting a Centralized and Risk Based approach to not just site monitoring but
    whole study monitoring.
  • Adopting a Risk-Based approach to
    computer systems validation.
  • Refining CAPA and RCA processes and tools to support the overall new QRM approach.


To download the published version, please click here.

Contributed by Jeff Handen  |  Senior Consultant  |  TayganPoint Consulting Group  |  |  LinkedIn

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