Clinical Database Transfer
The original CRO contracted a third party to build the study database in an electronic database platform not previously used by the Pharm-Olam study team. Since the clinical database is a critical component in subject data collection and analysis, we knew the shift of responsibilities to Pharm-Olam had to be managed carefully, be transparent, seamless, and have no impact on enrolment and site interactions.
Pharm-Olam's Data Management Team engaged with the original clinical database developer immediately upon notification of rescue award to understand the steps to transfer ‘ownership’ from the originally contracted CRO to Pharm-Olam as quickly and efficiently as possible. With prior experience in rescue study database administration, we outlined a detailed transition plan to the sponsor, the study team, and prepared our Data Systems Designers to assume administrative responsibilities. Within a very short span of time, our Data Manager completed system administrator workflow training, updated older documentation to Pharm-Olam’s robust DMP template to outline study processes, and transitioned the clinical database over the weekend to a new website link without any enrolment delay or site downtime.