Clinical Operations
The TFS Clinical Operations Unit has extensive experience in managing all aspects of national and international Phase I to Phase IV clinical trials. The unit is capable of running all the necessary stages from the study outline to the final clinical study report and its publication; including the outline, planning, coordination, management, performance, termination and reporting of the trials. Our in-depth knowledge of the local regulatory requirements and our network of investigators help to ensure that the trial objectives will be met on time and that costs will be kept within the budget.
The Clinical Operations Unit can provide the following services:
- Coordination and total project management
- Writing essential study documents such as:
- Investigator's brochure
- Clinical outline
- Clinical study protocol
- Clinical study report
- Regulatory authorities and ethics committee submissions
- Conducting feasibility studies
- Investigator recruitment
- Financial contract management
- GCP monitoring
- Management of drug supplies
- Study administration
- Medical writing.
