Clinical trials that definitively answer important scientific questions in a timely and economical manner require innovative approaches to several key areas. The TIMI Study Group provides detailed guidance on operational aspects and overall trial management based on decades of experience and lessons learned from our over 65 successful trials. Each trial has a dedicated team of cardiovascular clinical trialists and project managers who work closely with each other and the sponsor to ensure optimal trial execution.
Site Identification
TIMI’s record of completing trials on time or early stems from our careful selection of sites that are experienced and qualified for a given trial, coupled with streamlined, rapid activation. To that end, our database contains more than 5,000 investigators who have participated in trials studying therapeutics across a broad range – from the acute inpatient setting to primary prevention in stable outpatients.
National Lead Investigators
TIMI has a dedicated international network of physicians and key opinion leaders who serve as National Lead Investigators (NLI) in the countries where we conduct clinical trials. The NLI is expected to actively participate in confirmation of the list of sites to be invited and support achievement of local prescreening and recruitment goals.
Site Start-up
A TIMI Project Management team is responsible for oversight of the site approval and activation process. The TIMI Project Manager conducts regular teleconferences with the individual country teams to ensure the regulatory process is completed within expected timelines. The TIMI Study Investigators also support this effort through their relationship with the NLIs. We successfully use site prescreening as a requirement for site activation.
Site Training, Activation and Oversight
TIMI conducts Investigator training meetings on the protocol, trial operations and procedures. TIMI Investigator meetings are designed to provide the sites with the scientific background, details successful management of the protocol, be interactive and offer opportunities for questions regarding the study.
During the trial, TIMI will continue to monitor site performance and follow up with monitors in NA and NLIs in MOW to ensure good recruitment and monitor patient retention.
A key aspect is engaging the PI at the site, which TIMI is accomplished at achieving, given our long-term relationship with sites.
Higher site performance in data submission and patient retention leads to fewer problems with trial quality and less chance of major findings during regulatory audits.