Service Page: Study Setup
The study set-up phase can be considered to start from the Clinical Trial Application (CTA) to the recruitment of the first patient.
Close collaboration between the medical monitor and the various members of the cross-functional study team members is essential in this phase to build a medical management platform for the duration of the course of the trial.
Development and Review of documents and procedures related to the medical management of the study:
- Protocol, IB, ICF, SAP, DMP
- Medical Management Plan
- Protocol Deviations Guidance
- Safety Management Plan
Provide Regulatory support with responses to CA and IRB/EC
Ensuring the clinical study team are fully trained in all medical-related aspects of the project:
- Protocol Training
- Therapeutic Area and Disease Indication training
- Safety reporting and Deviation Management training