Cliantha Research provides sponsors with a cost effective, experienced group of Medical Monitors. They are available 24 hours a day, 365 days a year and are familiar with clinical research on a global scale. Our team of experienced Medical monitors ensures competent study medical guidance, medical safety and monitoring. Each clinical trial is assigned a medical monitor from the start of the project. The medical executive reviews the protocol, assists the medical writing team, discusses the practical implications with the Investigators, KOLS and ensures the protocol meets regulatory requirements as well as practical issues that are usually faced during execution.
The medical team is involved in training the CRAs on the therapeutic training prior to start of any study.
With a strong medical team in place we ensure that the clinical operations team is supported with a scientific background.
The medical team ensures safety reporting as per the regulatory requirements. Safety reporting includes:
- SAE case reporting of Initial/Follow up reports
- MedDRA coding
- Case narratives
- Global expedited case reporting
- Signal detection and evaluation
- DSUR preparation and submission
- Reconciliation of SAE