Medical Monitoring

Our Medical Monitoring team comprises of experienced clinical research physicians who handle queries related to patient eligibility, patient safety, protocol deviations and waivers. They are the primary contact for medical queries to investigative sites, sponsors and study team members to ensure quick resolution of medical issues. The Medical Monitors in consultation with Sponsors develop study-specific medical monitoring plan and ensure that the trials are conducted in compliance with the study protocol and approved medical monitoring plan.

The Medical Monitoring services include:

• Review of study documents – Protocol, Investigational brochure, Case Report Forms and Informed Consent Forms
• Handling protocol deviations
• Providing protocol waivers, wherever acceptable
• Medical review of statistical and clinical reports
• Providing inputs during study feasibility assessments
• Review AEs and lab reports

Safety Management

Through a team of dedicated and experienced Safety Physicians, we provide- highly credible inputs for the design of comprehensive study specific safety management plans, to ensure SAEs are reported and processed accurately as per the regulatory guidelines. The safety management service portfolio includes:

• AE and SAE case receipt, coordination and processing
• Medical review of AEs and SAEs
• Verification of AE coding
• Preparation of safety narratives
• Perform expedited safety reporting
• Reconciliation of SAEs
• Reconciliation of safety database with CRFs

Clinigene offers dedicated phone and fax lines to ensure 24/7 medical oversight of clinical studies.