Our Medical Monitoring services at AWINSA start before the study starts. The medical monitors help in reviewing some documents like IBs, protocols, CRF, DSMB charter and supporting documents. The medical monitors participate in the development of training materials to be used at the Investigator meeting and Site Initiation Visits (SlVs). They provide training in the therapeutic area, study indication, protocol, and safety reporting issues to the project team and Investigator sites. They review the safety monitoring plan and statistical analysis plan.
During the trial, the Medical monitors are available for any medical/scientific consultation and provide guidance and support to the sites and the study team for issues like patient eligibility and safety questions. They review.
After the end of the study, the Medical monitors:
The AWINSA medical monitoring team excels in providing comprehensive support throughout the clinical study process. Their expertise ensures meticulous review of study documents before the study commences, guaranteeing that all protocols are thoroughly vetted. During the study, they diligently analyze efficacy and safety listings, lab data, and adverse events, maintaining the highest standards of patient safety and data integrity. Post-study, their thorough review of safety reports ensures accurate and reliable outcomes. This holistic approach ensures the success and reliability of clinical trials, making AWINSA your trusted partner.
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