How Richmond Pharmacology Supports Sponsors Navigating ICH E6 (R3)

The updated ICH E6 (R3) guideline places greater emphasis on proportionality, risk-based oversight, and the effective use of digital systems in clinical trials. Interpreting and applying these principles in practice requires both regulatory insight and operational experience.

Regulatory strategy at Richmond Pharmacology is led by Dr Lisa Campbell, Director of Regulatory Strategy, who brings over 20 years of experience across regulatory science, clinical medicine, and drug development. Her background includes senior regulatory roles at the Medicines and Healthcare products Regulatory Agency (MHRA), where she served as a Senior Medical Assessor and acted as Lead Assessor during the COVID-19 pandemic. She has also contributed to the development of innovative regulatory frameworks, including the Innovative Licensing and Access Pathway (ILAP), and advises on global clinical programmes for gene therapies and rare diseases.

This experience supports a practical interpretation of ICH E6 (R3), particularly in areas where the guideline introduces greater flexibility, including quality by design, proportionate oversight, and data governance for digital and decentralised trials.

Richmond Pharmacology also actively contributed to the public consultation on ICH E6 (R3). Our input focused on ensuring that the guidance appropriately reflects the realities of early-phase and specialist clinical research, while maintaining high standards of participant safety and data integrity.

Key areas of contribution included:

Recognising investigator diversity, advocating for differentiated oversight that reflects the experience and capabilities of professional investigators without imposing unnecessary administrative burden

Promoting collaborative trial delivery, emphasising constructive relationships between sponsors, investigators, regulators, and participants

Supporting future investigator capability, recommending flexible and practical training approaches to develop and retain the next generation of clinical investigators

Through this engagement, Richmond helps ensure that sponsors benefit from an interpretation of ICH E6 (R3) that is balanced, investigator-aware, and aligned with both regulatory expectations and real-world trial delivery.