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Medical monitoring

At G7 Synergon we understand that safety is of primary concern during all phases of clinical research. Our medical monitors provide medical review and management of clinical trial activities for our clients.All our

 monitors are physicians and therapeutic specialists having extensive training and experience across a wide range of therapeutic areas and technological platforms. Our medical monitors can work independently or become fully embedded into sponsor’s teams.

Medical Monitoring Services include:

• Generation of medical queries
•  Study decisions regarding inclusion/exclusion deviations, dosing queries, concomitant medication requests, emergencies, etc.
•  Evaluating study protocols and informed consents
•  Analyzing and reporting Serious Adverse Events (SAEs) and Unexpected suspected SAEs
•  Tracking participant’s safety throughout the trial
•  Assessing the benefits and risks on an ongoing basis
•  Identifying safety signals and safety trends
•  Trend analyses for safety parameters during the trial
•  Medical reconciliation of the clinical database
•  24/7 medical consulting services
•  SAE narrative writing and submissions to regulatory
•  Literature evaluations (scientific, efficacy, safety and competitive analyses)
•  Post marketing safety narratives.



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