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PHARMACOVIGILANCE

Successful pharmaceutical development, achieving safety results that protect both your investment and your patients requires perceptive management of Serious Adverse Event (SAE)/Adverse Event (AE) monitoring, analysis, and reporting. The key to reliable Adverse Event Processing is strict adherence to regulatory directives and guidance, consistency of data retrieval and documentation, and the high index of suspicion required to identify and assess critical safety signals.

Pharmacovigilance safety database is the central repository for individual case safety reports or ‘ICSRs collected for a company’s medicinal product(s) from all sources globally. Our safety and pharmacovigilance teams support clinical trial and post-marketing safety surveillance. With patient safety as the critical component in product development, our quality focus aligns us to partner with our customers to provide both standalone and integrated services throughout the life cycle of a product. Our seasoned healthcare professionals deliver expertise in tracking and investigating Serious Adverse Event (SAE)/Adverse Event (AE). Our services include but not limited to:

  • Case Processing

    • Receipt

    • Triage

    • Data Entry

    • Assessment

    • Medical Review

    • Quality Control

    • Regulatory Authority Distribution

    • Regulatory Submission

  • Medical Coding

  • Safety Narrative Writing

  • Safety Signal Management

  • SAE Reconciliation

  • Safety Database

  • Submission-ready Individual Reports

  • Aggregate Reporting

  • Annual Safety Reports

People, processes, and systems that ensure reliability. 
Automates document distribution, improving speed, accuracy, and patient safety.