Risk-Based Oversight Redefined: How E6R3 is Reshaping Vendor Governance

At the SCOPE Europe 2025 conference, industry experts underscored how ICH E6(R3) is transforming the way sponsors approach vendor oversight. The updated Good Clinical Practice (GCP) guidelines emphasize flexibility, decentralization, and technology integration — urging organizations to adopt risk-proportionate oversight models. Natalia Buchneva, risk management lead at UCB, highlighted that with the proliferation of niche and digital vendors, traditional one-size-fits-all oversight no longer suffices. The shift toward hybrid and decentralized models has amplified the importance of identifying what is truly critical to quality and aligning oversight accordingly.

The discussion focused on the operational implications of working with a broader ecosystem of service providers — from CROs and labs to digital health and cloud-based solutions. As Buchneva emphasized, sponsors must move beyond contractual controls and procurement-based assessments to a model grounded in proactive risk management and data-driven decision-making. With data volumes and metadata complexity growing, sponsors are being challenged to define which processes and systems most directly affect patient safety and data integrity, and to tier oversight activities based on that analysis.

Integrating Risk Management into Vendor Strategy

The updated GCP framework places strong emphasis on early integration of risk management into the vendor lifecycle. Instead of focusing solely on post-award key performance indicators (KPIs), organizations are encouraged to front-load risk analysis — beginning at protocol design. The approach starts with identifying critical data and processes that directly support study endpoints, and then mapping vendor deliverables to those factors.

Buchneva described a structured model used at UCB, where vendor qualification results, IT risk assessments, and study-specific factors are combined into a quantitative risk profile. Each vendor is classified as requiring in-depth, standard, or low oversight, with oversight plans tailored to reflect the vendor’s criticality. For example, vendors providing digital tools such as eCOA or IXRS platforms — which maintain blinded or safety-critical data — are placed under in-depth oversight requiring direct sponsor involvement, audit trail reviews, and regular data validation checks. Conversely, non-critical vendors may fall under CRO-managed standard oversight, supported by routine metrics and quality management processes.

To operationalize this, UCB has embedded vendor oversight into its broader Risk-Based Quality Management (RBQM) framework. The process begins at protocol development, where study-specific vendor risk assessments are completed before finalization. Outcomes are captured in a vendor management plan that documents decisions, risk rationales, and oversight cadence — a key regulatory expectation under GCP R3.

Digital Systems Bring New Oversight Obligations

A major theme in the session was the rising prominence of computerized systems within vendor oversight. The new GCP revision explicitly requires sponsors to maintain an inventory of all computerized systems used in a trial — identifying their intended use and classifying each as critical or non-critical. This means that even third-party technologies supporting trial operations must undergo study-specific validation review and inclusion in the vendor management plan.

Buchneva noted that this marks a significant regulatory shift by indicating that for every trial, you now need documented justification for how system configurations were established, how validation was ensured, and how oversight will be maintained. Sponsors are expected to demonstrate a risk-based rationale for their monitoring approach — for example, by implementing periodic audit trail reviews or by documenting system testing performed by IT or data management SMEs.

The oversight of digital systems is no longer optional; it is integral to demonstrating control over data quality and compliance. Furthermore, vendors themselves now bear expanded accountability. Under the new expectations, critical service providers must report incidents directly and maintain defined escalation paths to sponsors, creating a three-tier governance model spanning sponsor, CRO, and technology providers.

From KPIs to Risk Signals: A Data-Driven Oversight Model

Traditional performance assessments — centered on metrics such as timeliness or deliverable completeness — are proving insufficient in this new environment. Instead, companies are pivoting toward continuous risk monitoring through centralized data analytics. UCB, for instance, uses Power BI dashboards to aggregate vendor-related risks across studies, allowing stakeholders to visualize risk trends and escalate recurring issues to the program or enterprise level.

This data-centric oversight enables multi-stakeholder governance, engaging procurement, quality assurance, data management, and clinical operations teams in a unified framework. As Buchneva emphasized, vendor oversight is “a multi-stakeholder process, not just a project manager’s function.” By integrating risk data from RBQM systems, issue logs, and CAPAs, organizations can shift from reactive quality management to predictive risk mitigation.

Building a Two-Way Governance Flow

Another critical element introduced in the session was the concept of bi-directional information flow — ensuring that risks and lessons learned travel both upward and downward through the organization. When risk patterns emerge across multiple studies involving the same vendor, these are escalated to program-level reviews for strategic action. Conversely, enterprise-level insights on vendor reliability or system vulnerabilities must be communicated back to operational teams managing ongoing studies.

This continuous exchange ensures that operational staff are aware of systemic risks, while leadership maintains visibility into study-level performance. The approach aligns with the GCP R3 ethos of embedding quality into processes rather than relying on retrospective audits.

Future Directions: Embedding Traceable Oversight

The closing segment of the session emphasized documentation, transparency, and traceability as the pillars of future vendor oversight. Regulators expect sponsors to demonstrate not only that oversight occurred but also that it was risk-proportionate and justified. As the number of specialized vendors continues to grow, so too will the need for dynamic, digitalized oversight models that integrate with existing quality systems.

Buchneva summarized the industry’s direction succinctly: oversight must be documented, risk-based, and traceable. The focus is no longer on exhaustive control but on intelligent prioritization — ensuring that sponsor attention is directed where it matters most: on critical data, processes, and systems that determine trial outcomes.

In this new era of vendor governance, success will hinge on integrating quality risk management with digital oversight capabilities — turning GCP R3 from a compliance exercise into a catalyst for operational excellence in clinical research.