We care

In line with adjusting their operational model for executing clinical studies internally and with external partners, a pharmaceutical company chose to reduce technical liability by implementing a new clinical data repository (CDR). The legacy system was highly customized and increasingly difficult to maintain. Systems supporting the execution and analysis of clinical studies underly Good Clinical Practice (GCP) regulatory requirements with the associated need for thorough change control. The system replacement was affecting a central component of the customer's value chain with the according management visibility and impact on project participants' targets.

We act

As IT project leader we were managing a global team across the US, UK, Germany, China and India, with technical and business resources spread across all involved locations. The project was divided into 12 work streams, each co-led by a business and technical representative. The successful execution of the project required a high level of transparency and coordination across workstreams, particularly regarding development, documentation and deployment milestones and the organizational change management. The IT project lead was responsible for maintaining the project finances and oversee supplier contracts and related reporting and invoicing. Regular steering meetings with higher management were prepared and executed to share updates on project progress and seek guidance on critical questions to align department strategy with the project implementation.

We deliver

The project went live with a first release including a pilot set of active studies that will be executed within the new system and ready to host any newly initiated studies. Migration of locked and active studies from the legacy system to the new will be addressed in a second release, together with functional enhancements.