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Making a Clinical Research Organization Project Run Smoothly


When embarking on a new outsourcing project, there are a few initial steps that must be taken to ensure a project runs smoothly from the start. Following a formalised handover from business development to operations, a face-to-face kick off meeting is important.

The scope of the project must be discussed in great detail with the sponsor so that expectations for both sponsor and the Clinical Research Organization (CRO) are aligned. For example, if the CRO is requested to use the sponsor’s SOPs then these should be analysed to see if they will impact the time required to complete the project. All deliverables and assumptions must be clearly documented along with the risks and their corresponding contingency/mitigation plans. A time/resource plan must be agreed and the “dependencies” that might affect the delivery must be understood by both parties. The better the planning up front, the smoother the project will run.

Ownership of communication with the sponsor needs to be allocated to an individual in the CRO and it is important that key members of the team are introduced to the sponsor. From the outset, the project manager must drive execution against plan and communicate regularly and openly with the sponsor to ensure progress is transparent and that any major issues are managed in a collaborative environment. Sponsors tend to be a little bit more hands-on at the beginning of a project until a few weeks go by and a certain level of comfort is established that the project is going to plan. The first deliverables will be carefully reviewed to verify that the required level of quality is in place.

Teething problems

Very often the contingency plans agreed up front can be put to the test early in the project if the sponsor delays or introduces a last minute change to the protocol. If the CRO is to work to the sponsor’s SOPs or on the sponsor’s own systems then there can be a learning curve, which is best minimised through a formal training programme.

Also, it is important to scrutinise the queries coming in from the sites early so that they can be minimised before they multiply across sites. Every sponsor dislikes change orders and every CRO should do everything to avoid them. Therefore, there should be an ongoing effort to tackle potential changes to budget or timelines. There are inevitably some additional requests that materialise after the project has commenced so it is advisable to have a contingency budget agreed beforehand to cover these items.

The right team

Selecting the right team is also critical to the success of a project. A CRO should have its employees well catalogued in terms of their competency, years of experience and therapeutic experience. There is usually enough time between contract negotiation and project start to “pre-book” the most appropriate resource for the project. This is key to the successful running of the project and leads to a high level of customer satisfaction if the sponsor can be guided by the prior experience of the project team. Where there is a large pool of resources available, the sponsor should take the initiative and ask for a selection of CVs to review in order to play a part in selecting the team for their project.

Integration of CRO employees with sponsor staff is usually quite a speedy process because there is an opportunity to ask many questions and have them answered immediately in the first few days. Arranging a short induction programme in advance can make the CRO employee feel a lot more comfortable right from the outset. CRO employees working on site with the sponsor also get the opportunity to attend ad hoc team meetings, which assists in getting the project off the ground. Ultimately, the project manager plays an important role in ensuring all team members, regardless of their location, are kept well informed of project issues.


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