Advanced Gastric Cancer

To meet the challenges in patient recruitment, Quintiles relied on its therapeutic experience and extensive global site network to select the study sites most likely to treat patients meeting study entry criteria. In order to assist oncologists in working with the primary-tumor-related inclusion criteria, CRAs provided training to all sites based on a radiological briefing document.

To ensure a smooth study start-up, Quintiles provided a dedicated regulatory lead to work with local experts in each of the participating countries, assigned study site coordinators to key sites and as-needed expert consultation to all study sites, monitored each site to ensure that it had the appropriate resources, and held frequent face-to-face meetings to coordinate with the project management teams, CRAs, and vendors.

CTLs and CRAs with medical degrees participated in the medical review of the case report forms to facilitate data clean-up for a timely database lock.