Highly experienced in multi-national cardiovascular clinical trials, Quintiles utilized its networks to identify sites rapidly and worked closely with National Coordinators to finalize site lists. The team disseminated study awareness materials, held interim investigator meetings, and practiced proactive site management tailored to individual sites’ needs. Quintiles and the customer created a shortened informed consent form that expedited national approvals.
After Quintiles quickly relayed sites’ concerns about the dose of the active comparator to the customer, a briefing document about the dose-selection rationale was promptly prepared and distributed.
Study closeout training was provided to CRAs and investigators just before the final patient visits and Quintiles worked with sites to produce tailored closeout plans. Targets for data collection and cleaning were set for countries and CRAs, and rewards for achieving targets were established.