T-33: Impact of Strategic Partnerships With Clinical Trial Sites and Role of Alliance Managers in Execution
Srinivas Guiri Pai Raikar
Strategic partnership with clinical trial sites and its impact on patient recruitment rate, patient recruitment numbers and turnaround time
Leading Pharma companies and Contract Research Organizations (CROs) have developed preferred relationships or alliance with their best performing sites
Data across 31 completed studies in 7 TAs from Phase II to Phase 3b across Asia Pac looking was analyzed for Alliance sites and core sites
Analysis of 31 completed studies in Asia across 21 indications in seven therapeutic areas from Phase II to Phase 3b provided insights into difference in performance of these Alliance sites in comparison to the core sites.
• On an average the Alliance sites recruited 47% faster and 47% more than the core sites
Another data analysis on startup cycle timeliness in 2016 revealed that
• Alliance sites reduced the time to execute a CTA by 12% with sites with higher level of engagement executing it 20% faster.
Similar to R & D partnerships, leading pharmaceutical companies and Contract Research Organizations (CROs) have developed alliance with sites. These sites are categorized based on various criteria and intensity of engagement as Alliance sites or core sites. The success of the collaboration is largely dependent on dedicated alliance managers appointed to manage the relationships and performance of these alliance sites through joint governance committees. Alliance sites have also reciprocated by having Clinical Research Center or Single Point of Contact (SPOC) to liaise directly with the alliance managers. Thus moving away from a traditional transactional approach where there is interaction and learning between Site and CRO only during the course of the study but there is no continuity. This lack of continuity also results in loss of opportunity to build on further from the lessons learnt from one study to the other for both, the Site and the CRO. The Alliance managers maintain regular communication with assigned sites on project and non-project issues such as aggregate site performance and compliance with contracts, business strategy, mutual pipelines/planning, and initiatives to drive participation and productivity.
The outperformance of these alliance sites suggest that moving towards a transformational Site-CRO/Pharmaceutical partnership does provide optimal solutions to expedite global drug development.