Pharmacovigilance

 We are committed to provide our expert service for pharmacovigilance to monitor, assess and report on the safety of investigational products and detect any change to their risk-benefit profile. We work closely with sponsors, sites and regulators to assure compliance against all relevant reporting requirements.

Mediclin provides flexible solutions to meet the needs of regulators. Our systems and processes have been specifically designed to meet the needs of the full gamut of sponsors.

Our services include:

  1. Individual Case Study Report (ICSR)
  2. Signal detection
  3. Periodic reporting
  4. Risk-benefit assessment
  5. Medical monitoring

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