Additional Services

Sitero provides wide range of other drug safety support services. We provide best-in-class one-stop solutions to our clients.

Be it accessing Eudravigilance restricted area for update and maintenance of critical information regarding client’s PV system or providing globally complaint regulatory inputs, our Eudravigilance trained staff is available to support such offerings.

Additional Services

  • REGULATORY INTELLIGENCE

    • Periodic review of existing global PV regulations
    • Preparation of safety reporting rules matrix based on the global requirements of case submissions
    • Providing review, assessment, and recommendations on the impact of changing regulations on client’s PV Systems
  • PHARMACOVIGILANCE MASTER FILE (PSMF) CREATING & MAINTENANCE

    • Generation of PSMF number from Article 57 Database
    • PSMF SOP authoring support
    • Preparation of PSMF maintenance plan
    • Collaboration with client and other relevant departments for collection of PSMF data
    • Periodic review and maintenance of PSMF body & Annexes
    • Preparation of summary of PV system
  • PV QUALITY & COMPLIANCE MANAGEMENT

    • Conducting PV audits
    • Ensuring suitably skilled and adequately trained staff assigned for respective activities
    • Setting-up Key Performance Indicators
    • Placing adequate effective checks and balances in place
    • Periodic Quality & Compliance metrics generation
    • Thorough analysis of the data & root cause analysis of any non-conformances
    • Preparation of Quality improvement plans
    • Mock audits and preparatory sessions

  • SAFETY DATA EXCHANGE AGREEMENTS (SDEAs) / PHARMACOVIGILANCE AGREEMENTS (PVAs)

    • 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

  • xEVMPD / ARTICLE 57 DATABASE MAINTENANCE

    • Updating the product profiles in xEVMPD
    • Updating other information such as PSMF location, EU QPPV details, etc.

  • PV SOPs AUTHORING & MAINTENANCE SUPPORT

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.