Study investigators are a critical component of every clinical study. We at DSP maintain a database of over 20,000 investigators in a variety of therapeutic areas. Additionally, we grade every investigator on performance and follow-up during each study.
Our site management services focus on key elements during the life of your project to ensure the investigator site is successful. We maintain metrics at each stage, evaluating the site on qualification, performance, and communication.
Site Management services include:
- Investigator confidentiality agreement and contract management.
- Trial Master File (TMF) setup and management.
- Investigator contract negotiation and management.
- Continual communication and training with investigators and site staff.
During study startup, a number of tools and metrics are utilized to ensure only the best investigative sites are selected. Site setup and management during the study startup phase is done quickly and efficiently.
Superior site management during the active phase of a project is achieved through a teamwork mentality. In-house staff, project management, and monitors work closely with investigators and site staff to provide study oversight, document management, effective communication, and assurance that we’ll always “tie up loose ends.”
Study closeout activities ensure all sites have a final “audit-ready” status and the TMF is complete. Site files are audited prior to closeout visits and a second review of all study documents, including study logs and drug accountability, are completed.
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