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Pharmacovigilance PDF Print E-mail

G7 Synergon provides Pharmacovigilance services for product safety as part of pre- marketing and post-marketing of drugs. We have a dedicated team of trained Pharmacovigilance specialists and physicians

 who are experts in recognizing, processing, analyzing and reporting adverse events to provide high quality safety surveillance services during all phases of clinical development. Our team is highly familiar and up to date with local safety reporting requirements of different countries and are in compliance with 21 CFR part 11 and GCP standards for Pharmacovigilance.

The team brings expertise and proven tools to support your Pharmacovigilance program. Working closely with clients, our safety experts help organize, coordinate, and facilitate your surveillance activities. In every case, we work closely with epidemiologists to review the data to identify new trends and signals or to follow up on theoretical or actual safety concerns that have been previously identified.

Pharmacovigilance Services include:

• Analyzing and reporting Serious Adverse Events (SAEs)and Unexpected Suspected SAEs
• Assessing the benefits and risks on an ongoing basis
• Trend analyses for safety parameters during the trials
• Signal detection and data mining
• Classification and triage of cases
• Quality check of data entry
• Coding of event/ Drug information
• Medical review of case reports
• Narrative writing of case reports and submissions to regulatory
• Follow up of case reports
• Safety monitoring visits
• 24/7 medical consulting services
• Verification of case information and case lock
• Periodic, annual and aggregate report writing
• Patient data management
• Retention of patient relations
• Ongoing data capture
• Capturing patient reported outcome
• Letters to Investigators
• CIOMS preparations
• Post-marketing surveillance services

IVRS/IWRS Service includes:

• Centralized Logistical Data Repository
• Seamless co-ordination between stakeholders
• Serious unexpected adverse reaction
• Periodic monitoring visits
• Update patient status
• Electronic Data Capture
• Real time Reports
• Clinical Trial Management System (CTMS)



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