Clinical Project Management Clinical Research / Monitoring

The Art of the CRO Transition: Set Up Your Study for Success

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Donna Hanson, VP of Strategy & Optimization
Donna Hanson, VP of Strategy & Optimization

The decision to change contract research organizations (CROs) for an ongoing study is not an easy one, but sometimes a move is necessary. The CRO may be underperforming, lack adequate resourcing, undergoing a merger or acquisition which can compete for priorities, or some other type of scenario that questions their ability to deliver and execute the study effectively and efficiently. Once the decision is made to transition, care needs to be taken to ensure a thorough plan is in place and details addressed to ensure all stakeholders are set up for success. While momentum builds to get activities transitioned, ensuring key areas are addressed and time is allocated appropriately will reduce the risk of long-term undesirable surprises. There are three areas that always need to be addressed early in transition: cost, study timelines and transition period.

Budget Planning

The early planning for a transition often starts with a litany of questions. Understandably, Sponsor’s don’t want to make a provider transition to find out a few months into that transition a large change order is needed. The new CRO should be well versed and able to provide a list of questions and items to ensure a comprehensive budget is provided. Seemingly basic details will need to be questioned and addressed:

·       Do site CDAs name the existing CRO?

·       How will the CRA transition occur between CROs (teleconference, onsite visit, etc.)?

·       What is the established site payment frequency?

·       Is there a need for data migration?

·       What type of quality audits will be needed?

Often it is best to gather the information required, to allow the CRO to build the budget and then collaborate to ensure all parties are aligned on the units needed; this will minimize down-stream surprises.

Re-assessing Feasibility

Preparing for a transition should include collaborating to understand the progress to date, points of delay, and adequate time to reassess feasibility. This requires extensive collaboration amongst all parties to ensure that everyone has a thorough and mutual understanding of what has been accomplished in the study already, and whether the original timelines and study goals are viable. Coupled with assessing the study’s status, projecting the new timeline is one of the more important steps in the transition process, as understanding where the timeline may be off—and identifying opportunities to make up for that time—will help to ensure the study stays on track. The incoming CRO will expect to see current site lists, a list of sites who declined the program, where each site is in the activation process, regulatory and ethics submission progress, to learn how many patients each site has enrolled, screen fail reasons and more. It is not uncommon that Sponsors may not have access to this level of information at their fingertips and are required to gather this information across systems or from multiple team members at the current CRO. Access to this data is critical because the new CRO should be expected to identify potential areas of delay and allow the information to guide strategy and realistic milestones. Just like unexpected budget changes are unwelcome, no one wants to transition a study and have further unexpected delays due to not taking time upfront to understand the feasibility and viability of the timelines.

Robust Transition Planning

Having set a realistic budget based on a comprehensive understanding of the current state of the study and having re-assessed feasibility and timelines, the Sponsor and new CRO must also develop a formal transition plan with defined roles, responsibilities and deliverable/due dates. Often the transition plan is derived from discussions held during a kickoff meeting. The formal transition plan should detail each trial activity and function, who is responsible for their conduct, what supporting technologies will be involved, data to be migrated across systems (as applicable) and how each element is to be evaluated and/or transitioned. Parties will need to make decisions as to the extent of the transition, the leadership and point people involved and agree on the timeline.

It is also critical to proactively plan the communication pathway with sites. Study sites are an integral part of the transition and losing sight of their contracts, relationship with the current CRO study team, grant payments and more can have a significant impact to enrollment and the longer-term relationship between the Sponsor and site.

The Sponsor and incoming CRO must set a tone of mutual respect between the transitioning parties to ensure a successful transition. The primary objective should be to create a safe environment that is conducive to bidirectional knowledge transfer, with clearly defined expectations and desired outcomes for both the transition and the study. All parties should display continued professionalism and be sensitive to the remaining work and site efforts.

Set Up for Success

It is incumbent upon the collaborative team to provide as much contextual and factual information as possible, to ask the right questions and to challenge each other to ensure study continuity and a smooth transition. Teams must prioritize a common understanding of current study status, re-assess study feasibility and develop a formal transition plan that defines roles and responsibilities to ensure a smooth transition. It is also crucial to coordinate with all vendors on the study team, set a tone of mutual respect between transitioning parties and display continued professionalism. By taking these steps and planning properly, transitioned studies are set up for success and can achieve goals efficiently.

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