We have a dedicated group of physicians comprising of various therapeutic area who handles queries related to patient selection and their safety concerns. They also look for the patients eligibility for the study and also ensure that while the study is ongoing, these subjects are safe and if atall any emergency happens these subjects can be taken care of promptly. The Medical Monitor in consultation with the sponsor helps in developing the study specific monitoring plan so that the trial can be conducted in compliance with the approved study protocol. The following are the main service which we provide under the Medical Monitoring Plan:
- Review the Protocol, Investigator Brochure and Case Record Forms as per the regulations
- Providing the inuts regarding any changes i to be incorporated in the
- Protocol and the Investigator Brochure along with the Case Record Form
- Review the SAE/ AE and provide suitable solutions
- Review the Lab Data as and when these are available.
- Providing Medical Reviews on the Clinical Study Reports.