MediciGlobal

Many life sciences companies are choosing to conduct clinical studies without the help of a full-service CRO. As study sponsors take on the task of managing multi-vendor teams, maintaining close relationships with study sites is becoming more important than ever.

Rather than relying on a single vendor to facilitate all aspects of the clinical trial process, a growing number of study sponsors are instead electing to unbundle CRO services and/or use niche-service providers. In a recent survey of clinical project managers*, Applied Clinical Trials reported that reliance on CROs for monitoring, data management, and other functions traditionally managed by CROs appears to be declining: 77% of those surveyed reported often or occasionally choosing niche-service CRO’s instead of full-service CROs. As a result, clinical teams are investing a greater percentage of their limited resources in managing the increasingly diverse team of vendors involved in each trial.

While this division of labor often results in cost-savings for study sponsors, it may present challenges for communication and relationship-building with study sites. Even with a highly experienced and effective clinical team, communicating consistent messages can become difficult when numerous stake-holders are involved. Particularly in the area of patient recruitment and retention, maintaining close ties with study sites is critical because:

• Accurate, timely information on site initiation and regulatory status is needed to quickly implement recruitment plans.
• Study coordinators who are clearly informed of study processes and goals communicate more effectively with patients, improving recruitment and retention rates.
• Understanding site dynamics ensures that key information gets to the right person at the study site.
• Site-specific issues such as staff turnover can have a dramatic impact on recruitment and retention. Quickly identifying and counteracting these issues can minimize the impact.
• With limited recruitment advertising budgets, evaluating site capacity, readiness, and ongoing recruitment performance is critical in determining which sites should receive recruitment advertising support.

While CRO services may address some of these issues, they rarely if ever provide study sites with a full-service support structure with the single purpose of helping them recruit and retain study participants. This support structure is absolutely essential in the absence of a traditional, full-service CRO.