Clinical Study Management Services

Clinical study management involves the application of resources across the various moving pieces of a clinical trial once that study has been implemented. Effective management requires study teams that understand all components of the trial process including the time required for contract execution (sites and vendors); availability of study kits, drug and other materials; as well as the requirements of IRBs and regulators.

EndPointe provides the following services in support of effective study management:

• Clinical Site Management including regular site communication to ensure smooth implementation of study procedures across institutional teams; tracking of recruitment, and identification of site issues that are preventing successful study implementation.
• Vendor Management to ensure contracted vendors are providing services per the original plan and contract and activities are proceeding in a timeline that matches expectations.
• Clinical Monitoring Oversight (including monitoring plan generation, review and approval, hiring and management of monitoring teams, monitoring training, review and approval of monitoring visit reports, and monitoring budget management). Training of monitors may also be provided.
• Overall Project Management: aided by planning tools such as Gantt Charts and Project Plans to identify critical path items, EndPointe can provide experienced project management that oversees all components of your study.
• Protocol Deviation Management: Careful tracking and oversight of protocol deviations is critical to drive future amendments and to unsure your final study population remains within the efficacy analysis set. Insight into site compliance or training issues can also be discovered and corrected.