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.

Read More

Global Literature Search & Management

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

Read More

Aggregate Safety Report Authoring

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

Read More

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.

Read More

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.

Read More

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.

Read More