GLOBAL TRIAL MANAGEMENT

Conducting innovative clinical trials that enhance the understanding of cardiovascular disease and improve the care of patients requires both academic trial leadership and effective global trial management. The TIMI Operations team provides skilled trial management based on three decades of experience managing over 65 trials across six continents.

TIMI's Director of Operations leads the project management and functional area teams and provides executive oversight of each trial. In turn, trial management teams are led by experienced Project Directors who work closely with TIMI Principal Investigators to ensure integrated trial management. Project Directors oversee individual trial teams staffed by Project Managers and Research Assistants.

TIMI's trial management capabilities are enhanced by our core services groups including:

  • Clinical Events Committee
  • Safety Desk
  • Medical Hotline
  • Core laboratories for ECG, Biomarkers and Genetics
  • Biostatistics

We also manage scientific advisory boards, IDMC activities and can aid in FDA communications. Moreover, through our unique collaborations with National Lead Investigators we provide international sites with local support from key opinion leaders. We are able to integrate all these facets of trial operations with one common goal of executing the best trial possible.

Clinical trials that definitively answer important scientific questions require innovative approaches to several key areas. 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 settings to primary prevention in stable outpatients. Comprehensive and interactive training of PIs, site staff and monitors on the protocol, eCRF and event reporting mechanisms is pivotal to ensure quality reporting and maintaining commitment. We manage our trials to the highest quality standards to maximize time on study drug and minimize lost to follow up and withdrawal of consent.

TIMI has learned something from every completed trial. Not just in terms of testing the hypothesis, but just as importantly in terms of ways to improve conducting a clinical trial, so that for each trial we do, our team is proud to demonstrate that the hypothesis we tested was tested correctly, rigorously, and efficiently.