The challenge
An industry pioneer and veteran biotech, Roche, like other complex pharmaceutical organizations, struggled with complexity and consistency in its approach to clinical trial feasibility—leading to challenges for both site stakeholders and internal study teams. Roche’s use of multiple systems to conduct feasibility highlighted a lack of standardization and added to the inconsistency. Lack of system standardization resulted in the same questions sometimes being repeatedly asked of the same principal investigators (PIs), complicating an already time-consuming feasibility process. Internal study teams also suffered from not having a consistent, efficient process. Given that feasibility is performed infrequently on an as-needed basis, only when a new study is initiated, global and local study teams across different therapeutic areas often had no clear guidance on the process to follow or systems to use. To standardize its feasibility process, Roche implemented the Cognizant Shared Investigator Platform (SIP).
Our approach
As one of the original sponsors that helped design the platform, Roche was already on the path to transforming its clinical trial collaboration with research sites on Cognizant SIP. Roche was also one of the early adopters of the Cognizant SIP Feasibility module, having recognized the need to harmonize the feasibility process for both external site stakeholders and internal study teams.
Site staff entered the necessary data about their facility set-up and equipment (in a feasibility questionnaire) so that they could access and register to use Cognizant SIP. With all core information in the platform, Roche could focus its feasibility questionnaires on protocol-specific questions to solicit high-value information, eliminating the need to ask sites to spend time and effort providing redundant information about their facilities. Similarly, for Roche’s internal teams, establishing a streamlined process would help them reach the ultimate goal of shaving time off the feasibility process to bring medicines to patients faster.
