article
09.12.2019

The Top Six "Dos" and "Don'ts" of CRO Project Management: How to Ensure Seamless Communication Across the CRO-Sponsor Line

Previously, we laid out some of the key factors in choosing a CRO — one of them being the CRO's ability to adhere to a trial's timeline and budget. A great way to evaluate efficiency in these areas is to look at the organization's approach to project management. Does the CRO provide a clear picture of what the sponsor can expect, and what will the relationship look like throughout the duration of the trial?

Whether you are offshoring clinical trials or contracting to a domestic CRO, make sure the project management team is aligned with these best practices.

Top Three "Dos" of CRO Project Management:

1. DO: Identify a Single Point of Contact

The project management responsibilities for clinical trials can fall on more than one person, depending on the size and scope of the project. For the purposes of the CRO-Sponsor relationship, however, there should be one individual appointed to manage all communications. Industry experts promote using a dedicated trial manager who is involved from the beginning of the project. Ideally, the person should demonstrate strong leadership and communication skills, as well as research and technical experience.

At OCT Clinical, our "single-window" approach means that all exchanges flow through one highly-qualified project manager. By designating a single point of contact for the duration of the project, we ensure timely and clear communications for our sponsors and maximize the outcome of every trial.


2. DO: Determine a Clear Trial Scope and Timeline

In addition to appointing a project manager, the CRO is responsible for clearly communicating the details of the project scope and timeline. This information should be presented at the beginning of the relationship, and referenced throughout the duration of the trial. As anyone working in the clinical development space understands, these are likely to shift as the trial progresses. It is the project manager's responsibility to ensure all project plans are amended accordingly and made readily available to the sponsor.

A survey of clinical research specialists revealed that poor project management is a major contributor to clinical trial failure, often due to a lack of experience with scoping out large projects. Successful studies require an experienced trial manager to make sure the scope and timeline are thoroughly planned.


3. DO: Plan for Setbacks

At the outset of any clinical trial, a skilled project manager will take time to assess the risks and obstacles likely to arise down the road. These will vary depending on the location of the trial, its regulatory environment, the therapeutic area, and numerous other factors. A skilled project management team offers valuable foresight and can prepare the sponsor for the inevitable hurdles that characterize clinical development. When risk management strategies are present, it is much easier for CROs and sponsors to collaborate and course-correct.

Now, for the "Don'ts":

1. DON'T: Under-Utilize Technology

As outsourcing models in clinical research become more global in scale, technology becomes increasingly critical to the Sponsor-CRO relationship. CROs should not only provide robust project management systems, but implement their full capabilities. When choosing a CRO, ask about the clinical trial management system (CTMS) and how it will facilitate both parties throughout the trial. A strong CTMS will allow the sponsor to easily monitor all aspects of the trial in real time.


2. DON'T: Fail to Ask for Feedback

In any field, project managers need to be proactive in gathering the client's feedback. Clinical research depends on strategic planning and decision-making, so feedback is even more crucial to the project's success. OCT project managers are trained to gather feedback consistently throughout the trial, so that sponsors can be sure their concerns are addressed and the trial adapts accordingly.


3. DON'T: Be Opposed to Change

When project managers don't course-correct early on, their trials are far more likely to go over-budget. Today's trial managers face the challenge of reducing total trial costs by 30-60%, which becomes even more daunting when protocol revisions occur late in the process. Significant cost reductions are far more feasible when a dedicated project manager anticipates change and pushes all cross-functional teams to find and apply efficiencies in execution. In fact, modified site management practices have been found to contribute to a 60-90% reduction in overall trial costs.

Effective project management hinges on action. In other words, the project manager needs to know when it is appropriate to try new approaches while staying within the set parameters. CRO services are best delivered when the project management team anticipates the sponsor's changing needs, and offers new solutions when appropriate.
As the leading Eastern European CRO, with a large team and an extensive portfolio, OCT is poised to deliver the comprehensive project management services you need to conduct successful trials.


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