E2E Case Processing

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

Our experienced and technically skilled team is engaged in performing end-to-end case processing for all case types (spontaneous, clinical, literature, legal, patient support programs, etc.) with activities ranging from global safety inbox management until regulatory submissions to applicable world-wide regulatory authorities.

Our team is trained to perform data-entry in established global safety databases as well as Regulatory Authority portals such as EV-WEB and FDA SRP.

E2E Case Processing Services

  • Global Safety Mailbox Monitoring
  • Intake & Triage
  • Complete data-entry
  • Writing comprehensive narratives
  • Quality Review
  • Medical review
  • Case Distributions to Ethics Committees, IRBs, Licensee Partners
  • Distributions of Other Manufacturer Letters
  • Expedited reporting to WW RAs

Other Drug Safety Services

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.

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.