Project management

All COREX operations are governed by a process-based approach to project management that is guided by the Project Management Institute (PMI) guidelines. Each COREX project manager has 4+ years of industry experience who, as part of the on-boarding process, is required to undergo a vigorous multistep training on the Project Management Book of Knowledge (PMBok), Good Clinical Practices (GCP), Good Distribution Practices (GDP) and Standard Operating Procedures (SOPs). Having deep understanding of the entire lifecycle of a clinical trial, our COREXPERTS are able to address every logistical challenge and offer our clients comprehensive support at any stage of the project.

At COREX we understand how all components of a clinical trial are intricately interwoven and thus strive to adopt our project management activities to the entire R&D cycle. This includes:

Project initiation. At COREX each project begins with our Business Development Department where the scope of services is carefully determined, analyzed and documented. With the help of historical data, dynamic algorithms, and based on available study-specific assumptions a budget proposal is created. It then passes through our supply optimization and risk assessment process where clients are given detailed consultations on budget optimization options (patient kit size adjustment, resupply management, local sourcing options, etc.). A final budget proposal approved by the allocated project-manager is then negotiated with the client to meet both parties’ requirements.

Study supply planning. Prior to any project launch the responsible project manager gathers detailed information on the study (including drug stability data, exact site location, contact details of all parties involved, etc.) and with the help of intricate forecasting modeling creates a project plan timeline. As the next step a start-up session is organized to set up the needed report forms, cost-containment mechanisms and communication strategy. And finally, right before the project launch, a kick-off meeting with the project team is organized where project-specific training is given to everyone involved in IMP handling.

Clinical supply. When the project is officially launched it is the project manager who assures that the needed quality is constantly maintained. Project managers oversee the timelines, project cost and duration deviations and updating the client on key-project events. We pay extra attention to temperature and humidity control and thus treat the temperature records and printouts as the core elements of COREX`s monitoring and control processes.

Project close-out and archiving. Our continuous improvement plan analyzes both project’s successes and pitfalls, with a detailed after-study “post mortem” which is used for better planning and management of future clinical supply projects. Having a client-oriented focus we finish the project with an official closeout meeting, where the client’s feedback is requested and analyzed and an improvement action plan is created. Our services are not limited to the formal study closure date and we are always ready to provide subsequent “after-trial” support by providing access to primary documentation and track records.

Contact us to learn more about COREX Project Management!

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