G7 Synergon provides pharmacovigilance services for product safety for 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 pharmacovigilance group has their own SOPs and develops trial-specific SAE data bases. The team is highly familiar and up to date with local safety reporting requirements of different regulated countries.

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

Pharmacovigilance Services include:

• Receipt of Adverse Events
• Literature Review
• Data entry of Adverse Event information
• Quality check of Data Entry
• Classification & Triage of cases
• Coding of Event / Drug Information
• Medical Review
• Writing of Case Narratives
• Safety Data Reconciliation
• Verification of Case Information & Case Lock
• Aggregate Report Writing
• Periodic Safety Update reports (PSUR)
• Annual Safety reports
• Patient Registration
• Patient Data Management
• Retention of Patient Relations
• On-going data capture
• Capturing Patient Reported Outcome

IVRS/IWRS Service includes:

• Centralized Logistical Data Repository
• Seamless co-ordination between stakeholders
• Serious unexpected adverse reaction
• Update patient status
• Electronic Data Capture
• Real time Reports