Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs)

Maintenance of multiple SDEAs across different Licensing partners, business partners and distributors can be a cumbersome task.

Our skillfully trained team members are responsible for handling the preparation of SDEAs and ensuring the compliance.

Safety Data Exchange Agreements (SDEAs) / Pharmacovigilance Agreements (PVAs) Services

  • Preparation of SDEA or Pharmacovigilance Agreements (PVAs) templates
  • Authoring of SDEAs
  • Periodic review and timely updates of the established PVAs
  • Maintenance of comprehensive safety data exchange matrix
  • Deriving safety data exchange compliance
  • Monitoring any non-conformances or deviations to the respective PVAs
  • Providing complete oversight to the client and adequately documenting any delays, deviations and non-conformances and implementing CAPAs to prevent future occurrences
  • Performing record keeping activities

Other Drug Safety Services

E2E Case Processing

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

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Clinical Safety

We understand the criticality of maintaining Investigational Medicinal Product & Patient information in clinical trials.

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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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PV Quality & Compliance Management

Sitero ensures quality-driven PV services which are curated to the needs of our clients envisaging the compliance to the current global regulations.

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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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