Risk Management and ICH E6 (R2)

Chaucer / Life Sciences / Data Enabled Operations / Risk Management and ICH E6 (R2)

Due to the increased complexity of the clinical trial process, and the subsequent increased outsourcing of trials, ICH E6 (R2) encourages a higher level of oversight, documentation, quality and risk management by the sponsor.

ICH E6 (R2) changes the way the way clinical trials are required to operate in the following ways:

  • Requires a modernised approach to GCP to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.
  • Encourages the implementation of improved more efficient approaches to clinical trial design, conduct, and oversight while continuing to ensure human subject protection and data integrity.
  • Emphasizes the dynamic relationship and oversight requirements between Sponsor and the CRO and to apply additional oversight based on risk.

Risk Management in Clinical Trials

The most effective and economical mitigation actions happen early in any program of engagement, as there is greater opportunity to change and adapt but as time goes by, risk mitigations become more costly and less efficient to implement.
Chaucer Life Sciences use a learning cycle to make use of best practice and improve from lesson learnt activities.

What do we offer?

  • ​Support in the standardisation of processes to effectively identify and evaluate risk.
  • ​Implementation of a Risk Management Framework aligned to your organisational objectives, trial processes and macro environment.
  • ​Independent management of the framework across you as the sponsor and your vendors/CROs.
  • ​Toolset developed to include a risk register, presentation of risks, profiles and risk scores.
  • ​Training in the methods and toolset to become self-sufficient in your risk management process.
  • ​Promotion of a culture of employee involvement towards proactive risk management.

Risk Breakdown Structure

RBS offers a mechanism for a flexible and scalable Risk Management Framework. Our enterprise risk management system allows the co-existence of multiple risk breakdown structures within one system.

At the Clinical Program level, we focus on risks in the categories of:

  • Study Set-up
  • ​Study Conduct
  • Stronger, value-based relationships
  • Study Closure

The Vendor Engagement & Oversight (VEO) Solution

Find out more about our VEO solution here, which reacts to all components of ICH E6 (R2) including assessment, prioritization, implementation. Our unique vendor engagement and oversight solution will deliver peace of mind in your ongoing programs.

A sponsor may transfer any or all of the sponsor’s trial – related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.ICH E6 GCP Guidance 5.2.1

If you think we can help you to implement your project or programme strategy, please call us on:
+44 (0) 203 141 8400 in UK/Europe, or ​​​+1 713 821 1783 in the USA.

Alternatively, please send us some brief information and we can discuss things in more detail.