Practical CRO oversight and governance for biotech companies — from establishing the relationship through performance management, executive escalation and intervention when required.
Selecting the CRO is only the beginning of the relationship. Once a clinical programme is underway, effective oversight and governance help the sponsor maintain visibility of delivery, cost, risks, performance and key decisions.
For biotech companies with lean internal teams, the challenge is establishing sufficient oversight without creating unnecessary layers of meetings, reporting and process.
Henley helps sponsors establish practical governance around the CRO relationship, maintain visibility of performance and commercial issues, and provide senior-level support when problems require escalation or more significant intervention.
Where CRO performance has deteriorated, we can provide an independent assessment of the relationship and help management determine whether the priority should be recovery, restructuring the relationship or, in more serious situations, considering transition to another CRO.
Henley brings more than two decades of CRO industry experience, including strategic account leadership, commercial management and executive governance of clinical trials.
That experience includes working with sponsor and CRO leadership teams to review programme performance, resolve escalated issues and manage significant commercial and relationship decisions.
It also includes CRO rescue situations and the transition of multi-million-pound outsourced clinical trials between CROs.
This provides a practical understanding of the CRO relationship from both sides of the table — including how issues escalate, what can be done to recover performance and the implications when a relationship can no longer be effectively repaired.
Where an engagement requires additional clinical or operational expertise, Henley can bring experienced clinical consultants into the team, providing support appropriate to the programme and the issues involved.
Establishing how the sponsor and CRO will work together, maintain oversight, make decisions and resolve issues.
Establishing a focused set of measures that gives management visibility of programme performance and emerging issues.
Supporting senior-level review of CRO performance and helping sponsors address issues that cannot be resolved through the study team.
Maintaining visibility of changes in scope, forecast cost and the commercial implications of decisions made during the programme.
Independent senior support where CRO performance or the sponsor-CRO relationship has deteriorated and more significant intervention may be required.
Good CRO governance does not necessarily mean more meetings or more reporting.
The objective is to give the sponsor clear visibility of whether the programme is progressing as expected, whether important risks are being addressed, whether the CRO team remains appropriate, whether costs are tracking against expectations and where management decisions or escalation are required.
For lean biotech teams, governance should be proportionate. The sponsor needs enough information and structure to exercise effective oversight without creating a management burden that the internal team cannot sustain.
Where performance begins to deteriorate, effective governance should make it easier to identify the problem early, establish clear actions and accountability, and determine whether the CRO relationship can be recovered.
Performance issues do not automatically mean that a CRO should be replaced. Transitioning an active clinical trial can introduce significant operational, financial and timeline risk of its own.
The first step is to establish what is actually going wrong, why it is happening and whether the existing CRO has the capability and commitment to recover.
Henley can provide an independent senior review of the situation, help structure discussions with CRO leadership and establish the actions and commitments required to improve performance.
Where recovery is not realistic, we can help management assess the implications of changing provider and support the planning and governance of a CRO transition.
The objective is to help the sponsor make a considered decision based on the risks of both staying and changing — rather than allowing a deteriorating relationship to continue without a clear plan.
It should be proportionate to the programme and the sponsor's internal resources.
Typically this means clear responsibilities, an agreed meeting structure, a focused set of performance measures, documented decisions and a defined route for escalation when an issue cannot be resolved at study-team level.
The objective is effective sponsor oversight without unnecessary process.
There is no single set that applies to every study. Measures should reflect the important delivery, quality, timeline and commercial risks of the programme.
These may include recruitment and site progress, key milestones, data-related measures, CRO resourcing, important risks and budget performance.
The important point is that reporting should help management identify issues and make decisions rather than simply generate more data.
Start by establishing the facts, the impact on the programme and the underlying causes of the performance issues.
Where problems cannot be resolved at study-team level, structured executive escalation can help establish the actions, resources, accountability and commitments required from both parties.
The objective should normally be to determine whether the existing relationship can be recovered before accepting the disruption and risk involved in changing CRO.
Yes. Henley can provide an independent review of CRO performance and the sponsor-CRO relationship where management is concerned about delivery, resourcing, commercial issues, governance or persistent escalation.
The review can help establish the principal issues, assess the CRO's ability to recover and identify practical options for management.
Changing CRO during an active clinical trial is a significant decision and should not be taken lightly.
The decision depends on the seriousness and persistence of the performance issues, the CRO's ability to recover, the risks of remaining with the existing provider and the operational, financial and timeline implications of transition.
An independent assessment can help management understand those trade-offs before deciding how to proceed.
Yes. Henley has direct experience of rescue situations involving the transition of multi-million-pound outsourced clinical trials from one CRO to another.
We can support management in assessing the options, managing senior-level discussions and helping structure the commercial, governance and transition approach.
Where additional clinical or operational expertise is required, experienced clinical consultants can be brought into the team.
Yes. Henley's core expertise is CRO strategy, commercial management, governance and senior-level relationship oversight. Where an engagement requires additional clinical or operational expertise, we can bring experienced clinical consultants into the team. This allows the support to be tailored to the particular programme and issues involved without adding unnecessary resource.
Whether you are looking to strengthen CRO oversight, address deteriorating performance, escalate significant issues or assess whether a CRO transition may be necessary, we can provide an independent senior perspective.
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