CRO – Pharmacovigilance (PV)

Pharmacovigilance (PV)

At BICS, we bring together scientific excellence, ethical integrity, and advanced regulatory understanding to offer end-to-end CRO and Pharmacovigilance (PV) services that ensure safety, quality, and compliance at every step of your product's lifecycle.

With India emerging as a global hub for clinical trials and drug development, our CRO division stands as a reliable partner for pharmaceutical, biotech, and medical device companies across the globe. Whether you are in the early phase of drug discovery or post-marketing surveillance, we ensure every trial is accurate, timely, and aligned with international regulatory guidelines.

Pharmacovigilance (PV) Services

  • Adverse Event (AE) Reporting & Monitoring - 24x7 AE intake, processing, and follow-up with robust safety database support.
  • Signal Detection & Risk Assessment - Proactive identification of patterns to ensure early detection of safety signals.
  • Periodic Safety Update Reports (PSURs) / PADERs - Timely preparation and submission as per regional regulatory timelines.
  • Post-Marketing Surveillance (PMS) - Real-world monitoring for long-term safety and efficacy.
  • Literature Surveillance & Case Evaluation - In-depth medical review of published data for continuous vigilance.
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