Clinical Safety

We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials. Accurate evaluation of safety data is the key to bring a potential drug into market for human benefit.

We offer a wide range of distinguished services for effective analysis of safety data originating from clinical trials.

Clinical Safety Services

  • Unblinding of SUSAR reports
  • Expedited reporting of cases to WW RAs
  • Setting up Adjudication Review, Safety Review, Drug Safety Monitoring Board Committees

  • Arranging and managing safety review meetings with blinded and unblinded data

  • 24 X 7 Medical Monitoring services

  • Safety Management Plans

    • Medical Monitoring Plans
    • Blinding / Unblinding Plans
    • Data Reconciliation Plans
    • DSMB Charters
    • Clinical Trial ProtocolsSafety
    • Committee Review Charters
    • Clinical Study Reports

Other Drug Safety Services

Case Processing

We provide end to end (E2E) Pharmacovigilance and Clinical Safety services to Pharmaceutical, Biotechnology and Medical Device companies.

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Global Literature Search & Management

Sitero offers medical literature monitoring services by well trained and highly experienced literature experts.

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Aggregate Safety Report Authoring

Sitero offers comprehensive, concise and critical analysis of the risk-benefit balance of the medicinal products.

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EU & UK QPPV and/or Responsible Person (RP) Services

To be compliant with GVP Module-I, Sitero can offer to its customers EU & UK QPPV & RP services by duly experienced and qualified personnel with 24X7 availability to comply with EU & MHRA regulations.

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Safety Evaluation & Risk Management

Our medically qualified team with hands-on experience on signal management and risk minimization activities provides strategic medical support across various therapeutic areas.

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Additional Services

Sitero provides wider range of other support services. We provide best-in-class one-stop solutions to our clients: regulatory intelligence, pharmacovigilance master file (PSMF) Creation & Maintenance, XEVMPD / Article 57 Database Maintenance and PV SOPs Authoring & Maintenance Support.

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