When a live Phase 2a study faced operational and data-transition risks, a US clinical-stage biotech turned to ExperTrials for clinical trial rescue support. ExperTrials designed a flexible outsourcing model combining rapid assessment, senior fractional leadership and hands-on data-management delivery.
The Context
The sponsor was running a live Phase 2a study in APAC with an incumbent CRO responsible for key elements of study delivery. As the trial progressed, the sponsor became increasingly dissatisfied with the CRO’s performance, the level of operational control and visibility, and the way critical responsibilities were being managed.
The sponsor ultimately decided to terminate the collaboration with the existing CRO. Because the study was already active, this decision created an immediate need to protect continuity while preparing for an orderly transition. The priority was not simply to appoint another provider, but to avoid disruption to ongoing study activities, maintain control of critical data and systems, and ensure that responsibilities remained clearly owned throughout the change.
The situation was particularly sensitive because operational delivery and data transition had to be managed in parallel. Any poorly controlled handover could have affected study timelines, data integrity, vendor coordination and sponsor oversight. The sponsor therefore needed a model that could be mobilised rapidly without committing immediately to another large full-service CRO structure.
ExperTrials was brought in to help the sponsor regain control before completing the transition, combining senior fractional leadership with hands-on operational and data-management support. The objective was to stabilise the study, identify the most critical gaps and create a controlled path forward while preserving sponsor decision-making and study continuity.
The Challenge
- Live study environment with no room for disruption
- Operational and vendor coordination challenges
- Data transition and continuity risks
- Need for rapid oversight reinforcement without permanent hiring
The ExperTrials Solution
ExperTrials designed a targeted rescue model combining senior fractional leadership with hands-on functional delivery. The approach focuses on restoring control over study continuity, data transition and quality oversight without requiring a full CRO transfer.
- Fractional Clinical Operations leadership for governance, priorities and vendor oversight
- Fractional QA oversight to reinforce quality governance and inspection readiness
- A full data-management team supporting transition assessment, migration, UAT, cleaning and reconciliation
- Optional Medical Monitoring, CTMS and eTMF support as the study evolves
A 3–4 Week Clinical Trial Rescue Plan
The recovery approach was structured around a 3–4 week mobilisation plan designed to restore control quickly while minimising disruption to the live study. Rather than attempting a full provider replacement at once, ExperTrials sequenced the rescue into three overlapping stages: Assess, Mobilise and Stabilise.
Week 1 – Assess
The first step is to establish the facts and identify the most critical risks. This includes confirming ownership and sign-offs, mapping operational and data dependencies, and prioritising the decisions that could affect study continuity.
Weeks 1–2 – Mobilise
Once the key risks are understood, the rescue model is put in place. Governance and escalation routes are defined, the fractional team is onboarded, SOPs and reporting processes are bridged, and the EDC and migration approach is agreed.
Weeks 2–4 – Stabilise
The final stage focuses on controlled execution under active oversight. Activities include UAT and data checks, reconciliation, tracking of risks, issues and CAPAs, and preparation of the steady-state governance model for the next phase of the study.
The objective is to turn urgency into a controlled transition, protecting study continuity while restoring sponsor oversight and reducing operational and data-related risk.
Current Status & Recovery Objectives
The clinical trial rescue is currently in progress. ExperTrials is supporting the sponsor through the planned transition while maintaining a strong focus on study continuity, data integrity and sponsor oversight. Final outcomes will be added once the transition is complete.
These objectives are being addressed through the phased Assess, Mobilise and Stabilise approach, with active oversight continuing throughout the 3–4 week mobilisation period.
The aim is not simply to replace one provider with another, but to restore control where it is most needed and create a delivery model that can scale with the study as requirements evolve.
The immediate recovery objectives are to:
- Protect ongoing study and vendor transition
- Reduce uncontrolled downtime and transition risk
- Strengthen sponsor governance and escalation
- Establish a controlled path to steady-state delivery