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.

Clinical Safety

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

Global Literature Search & Management

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

Aggregate Safety Report Authoring

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

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.

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.

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.

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.