Integrated Risk Assessment Framework for R&D

Published 11 August 2026

Part 1: Framework and Implementation Foundations

Author(s): James Irwin, Arun Mathew, Seth McKinney & Simon Ward

Reviewer(s): Keisha Bryant, David Carter, Lucie Regne-Martos & Kyle Young

Executive Summary

The Problem: Quality Risk management in pharmaceutical R&D is essential but frequently fragmented. Fragmentation is no longer sustainable in a world of accelerated timelines, modality diversification, and distributed development models. When risk is fragmented, companies are exposed to late-stage surprises that could have been prevented and potentially delay patients receiving access to new medications. Function-specific processes create siloed risk assessments. Multiple assessments for the same product, each with different or even conflicting information, resulting in valuable risk insights generated during development being inaccessible to downstream stakeholders. Inconsistent terminology across ICH, ISO, COSO, and other frameworks further undermines enterprise visibility and inhibits effective automation and integration. ICH Q9(R1) explicitly calls for risk management that builds knowledge across the product lifecycle, yet most organizations lack the structures to deliver on this expectation.