Conducting Clinical Trials in

Project Management Clinical trials

The Project Management Group acts as the main point of contact with the Sponsor throughout the clinical trials process. A dedicated Project Manager is assigned to a specific study, and leads all the stages of the trial. These include protocol development and review, oversight of the regulatory applications, preparation and submission of ethics committee applications, planning and scheduling of the studies and monitoring through to clinical completion and study close-out.

The group is responsible for overseeing the issue and update of standard operating procedures (SOPs), ensuring that the studies are conducted in accordance with internal SOPs, the EU Directive (2001/20/EC), ICH GCP guidelines, and UK regulatory requirements. Other responsibilities include ensuring that all staff members receive the appropriate training, audit preparation and archiving of the documentation in accordance with UK regulatory requirements.

BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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