Project Management

Our study managers have extensive experience in the set up, budgeting and conduct of phase I through phase III international trials. Over the years, we have developed excellent professional relationships with key thought leaders in the field of medicine. This has proven valuable to sponsors of clinical trials, especially in critical situations, when drawing on these relationships has helped spur recruitment, thus allowing important study timelines to be met.

Services include:

• Site selection
• Study protocol proofreading and/or translation
• Study budget set-up and management (investigator payments)
• Creation of study operations guide / monitor manual
• CRF design consultation
• Compilation of EC trial submission package
• Study newsletters
• Supervision, coordination and follow-up of SAEs during the study
• Coordination with data management, laboratories and other partners
• Clinical study report and review