Clinical Monitoring and Operations
Strong site relationships and efficient study start-up
Successful study execution requires more than just source data verification (SDV) and on-site clinical monitoring. Our clinical operations team ensures efficient study start-up, quick enrollment, and high quality execution at the site-level through extensive therapeutic and regulatory knowledge, solid training programs, and development of strong site relationships. Our clinical operations experts also have extensive experience designing and executing decentralized and virtual clinical trials.
From project initiation through site selection and activation, our clinical operations team makes sure first patient first visit (FPFV) goals are met by conducting a thorough feasibility process and onsite qualification visits. During the enrollment and treatment phase, they keep a close eye on recruitment and retention, data quality, protocol deviations, and more to ensure that database lock happens promptly following last patient last visit (LPLV).
Identifying the right sites is critical to patient recruitment and successful execution of overall study timelines. The clinical operations team does this by:
- Evaluating the competitive landscape to determine studies competing for sites and subjects
- Conducting thorough feasibility to determine how many and which sites are needed
- Maintaining relationships with high performing sites that have a proven history of meeting enrollment goals and generating high quality data
- Assessing sites through qualification visits
Once sites are selected, the clinical operations team works diligently to complete study start-up activities needed for FPFV such as:
- Collecting site regulatory documents needed for IRB approval
- Managing site budget and contract negotiations
- Tracking IRB and contract dates to ensure prioritization and acceleration of site activation
- Conducting site initiation visits
- Participating in investigator meetings and training site staff
Enrollment and treatment
During the enrollment and treatment period, the primary goals of the clinical operations team are to ensure quality in the execution of the study and to mitigate risks to study timelines by keeping enrollment on track. Some keys to meeting these goals are:
- Building and maintaining close relationships with sites so that issues are identified and resolved quickly
- Maintaining oversight through timely trip report review and co-monitoring visits
- Tracking enrollment, protocol deviations, AEs, investigational product, and clinical trial materials
- E6R2 compliant quality management processes to review site trends via centralized clinical monitoring to ensure consistency and quality of the data
Real-time data cleaning and listing review during the enrollment and treatment phase expedite study close out and database lock. Our clinical operations team works closely with the data manager to ensure that data from sites is submitted in a timely manner. Quick and thorough close-out activities lead to efficient and on-time database lock and delivery of critical topline results.