S.C.MONITORIS offers a wide range of services for the conduct of clinical research:
In Clinical Research Management:
- Clinical training for CTAs / CRAs (in-house training, and on the job training)
- Feasibility studies
- Site selection and pre-study assessments
- Site initiation
- Organisation of investigator's meetings
- Submission to ethics committees
- Submission to Competent Authorities
- Project tracking /status reporting
- Budget negotiation
- Auditing assistance
- Translation of study related documents
- Trial & Site management
- Monitoring of clinical trials (Phase II to Phase IV, PMS, NIS)
In Clinical Research Trial Site Coordination:
- Clinical training for study site personnel / trial site coordinator
- Site management
- Patient Screening and Enrollment
- Schedule follow up visits
- Maintain and dispense drug and other study supplies
- Timely and accurate CRF transcription
- Ensure GCP adherence and compliance
- Data entry and data management as per global regulatory and audit standards
- Prepare site for audit visits and respond quickly to any queries