We approach site selection in three ways that make us different (and better). First, we have an integrated database of hundreds of thousands of clinical investigators. This database allows us to identify qualified investigators and sites based on previous clinical research experience as documented in the FDA’s 1572 database and clinicaltrials.gov integrated with published clinical trials from clinicalstudyresults.org and PubMed.
Together, we know how active each investigator has been in various indications over time and whether they have had any adverse audit findings. We combine this with feedback from our own experience and our IRB’s to provide an optimized universe of potential sites.
Second, we apply complex database searches to identify areas of high disease incidence at the County, State, postal code, and even Institution-level. Overlaying this information with our optimized site database provides a suggestion of which sites will have access to the largest well of potential subjects. Together this enables better enrollment with fewer sites.
Third, we use our proprietary trial management system, TEMPO™ Trial Manager, to track all aspects of study start-up and integrate start-up tracking activities with our eTMF. Our team believes that we are among the most efficient CROs in business when it comes to launching a new study.
Integrated Site Management
Clinipace Worldwide will ensure regulatory compliance by managing site relationships, logistics, documentation and reporting. At all times our CRAs are focused on keeping sites motivated and on track.
Using TEMPO™, each CRA manages site objectives and our monitoring workbench (task list) ensures quality data that is collected on-time and on-budget, including:
- Ensuring signed informed consent forms
- Source Data Verification (SDV), based on the protocol SOP
- Reviewing all eCRFs and discussing trends with site staff
- Evaluating eCRFs for serious adverse events
- Performing drug accountability
- Reviewing investigator study files for completeness
- Ensuring protocol compliance
- Encouraging and supporting sites
Our CRA specialists will prepare and manage study start-up documentation and site file notebooks, IRB preparation and communication, regulatory file review, site payment, site status reporting, and site close-out tasks.