Trial Oversight

Comprehensive Trial Oversight Solutions for Clinical Development 

Oversight Is Only as Good as the Data Behind It

ICH E6(R3) places responsibility for trial oversight squarely with the sponsor, regardless of how much has been delegated to Clinical Service Providers. This means having not only the appropriate contractual mechanisms in place, but also the systems, processes and data required to understand what is genuinely happening across your studies at any given time. For many organisations, this is where the gap exists. Oversight frameworks may exist on paper, yet the visibility needed to act on them in practice is inconsistent, reactive or absent.

Effective trial oversight is not about process for its own sake. It is about having the right information at the right time to make informed decisions on Clinical Service Provider performance, emerging risk and resource allocation. Achieving this requires a deliberate strategy, enabling technology configured to support it, and metrics that connect operational activity to quality outcomes.

Our Approach

Arithmos works with sponsors to design and operationalise oversight frameworks that reflect both the expectations of ICH E6(R3) and the realities of how your organisation conducts its trials.

A mature oversight programme begins with clarity on what is being measured and why. We support sponsors in defining meaningful KPIs and key risk indicators for their portfolio, drawing on TMF health metrics established through the essential records programme alongside operational data generated through your CTMS. Together, these provide a real time view of Clinical Service Provider performance, study progress and quality signals, enabling proactive management rather than reactive response.

Technology is central to making this possible. A well implemented CTMS does more than track milestones. It becomes the operational backbone of your oversight programme, surfacing the data that informs decisions and providing the audit trail that demonstrates sponsor control. We support the full journey, from evaluating and selecting systems aligned to your needs, through implementation and optimisation to support oversight workflows, and ensuring systems continue to evolve as your organisation and portfolio grow.

The scale and complexity of your portfolio also matter. The oversight infrastructure suitable for a sponsor running two or three studies differs significantly from that required to manage a broad and complex programme. As organisations scale, their systems, data and governance frameworks must scale with them. Arithmos supports sponsors in building oversight frameworks that are appropriate for their current stage and designed to mature alongside their growth.

Our Integrated Approach Includes:

• Oversight Strategy Design and Governance Framework Development

• KPI and KRI Definition for Clinical Service Provider Performance and TMF Health

• Clinical Service Provider Oversight Framework Design and Operational Support

• CTMS Evaluation, Implementation and Optimisation for Oversight Enablement

• eTMF and CTMS Integration to Support Unified Oversight

• System and Vendor Selection Advisory

• Oversight Maturity Assessment and Scalability Planning

• Inspection Readiness Through Documented Oversight Evidence