How quickly does the CRO respond to requests for information? Will there be adequate training and patient recruitment support throughout a trial? If there are needs at the site level that may benefit from the additional resources a CRO can provide, they should be addressed as early as possible.Ĭlearly defining the roles and responsibilities as early as possible is extremely valuable to the overall relationship between a site and CRO. Sites should take advantage of the study start-up stage to conduct reciprocal feasibility on the CRO. Many CROs implement internal processes during feasibility aimed at distributing the workload more evenly among all sites.
When a few, high performing sites take on the majority of the work involved, CROs strive to implement processes to distribute the workload more evenly among all sites. All stakeholders are clearly invested in ensuring a highly productive, efficient clinical trial - therefore selecting high performing sites is critical to this success. CROs utilize this essential period as an opportunity to evaluate a site’s responsiveness and follow-up, and analyze the quality and accuracy of the information provided. The feasibility and study start-up stage is a fundamental predictor of success and a key indicator of a site’s performance. The study start-up stage offers ample opportunities for sites and CROs to establish the foundation of a trust-based relationship. Rather than a customer and vendor relationship, sites and CROs should strive to develop strategic alliances, partnering seamlessly through an entire clinical study and beyond. The strength of the relationship between the site and CRO during study start-up is an important factor in creating a successful study outcome.
The critical nature of this phase places significant pressure on all stakeholders. The study start-up phase sets the tone for a clinical research trial and is crucial to the overall success of a program. A Successful Clinical Trial Begins with the Study Start-Up Phase
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