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Pharmacovigilance Services

We at JSTL offers comprehensive Pharmacovigilance and safety monitoring services from early development support through post-approval initiatives. We have experienced and skilled medical professionals with first-hand knowledge of regulatory requirements.

ICSR Management

Our case processing team can serve as an extension of your team, following your standard operating procedures, so that you can always manage fluctuation in case volume. Our Specialists have expertise in case processing from clinical trials to post-marketing sources, literature and observational studies. Our focus is on quality of data entered into the safety database in order to ensure that your safety data set is processed consistently and according to international standards.

  1. Case intake and Triage
  2. Data entry
  3. Case Coding
  4. Narrative preparation
  5. Quality control and medical review
  6. Reporting

Aggregate Safety Reports

We offer support in monitoring the lifecycle of companies’ products and safeguard their benefit/risk profile through periodic safety reports and risk management plans, to ensure that safe and effective medicines are delivered to patients worldwide. Our experts have an in-depth knowledge of both the technical and regulatory aspects and they can assist you with the preparation of necessary safety documents, scientifically based documents where the amount of information provided is proportionate to the risk, to optimize the continued safe use of the medicinal products.

  1. Periodic Safety Update Reports (PSUR)
  2. Benefit-risk evaluation report (PBRER)
  3. Periodic Adverse Drug Experience Report (PADER)
  4. Developmental Safety Update Report (DSUR)
  5. ACO reports – Addendum to clinical overviews

Risk Management Plan

  1. Risk management planning
  2. Risk management plan development
  3. Development of risk minimization
  4. Assessment of risk minimization
  5. Risk management studies

Signal Detection

The evaluation of safety signals is part of routine pharmacovigilance and is essential to greater patient safety and improved public health through better detection, assessment, understanding, and prevention of adverse reactions. Through our experienced team we make sure your Safety Signals Management activities are comprehensive and your actions always timely, accurate and compliant.

  1. Signal Detection, Prioritization
  2. Statistical Analysis in Large
  3. Adverse Event Databases
  4. Active Surveillance
  5. Signal Assessment using pharmacovigilance database

Medical Information Call Centre

  1. Adverse events
  2. Product complaints
  3. Medical information
  4. 24 X 7 Support

Other Integrated Services

  1. QPPV Services
  2. Literature search and medical information
  3. Complete Pharmacovigilance system set-up
  4. SOP development
  5. Inspection and Audit support
  6. Training to the staff