Drug Safety & Pharmacovigilance

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

We have Medical Information Call Center support, E2E case processing and submissions, signal detection, aggregate reporting and automation consulting services and solutions. We leverage trained professionals (pharmacists, registered nurses, Medical Doctors, etc.) across the AE life cycle to ensure all safety concerns are identified, managed and reported in a compliant and quality manner.

Drug Safety Services

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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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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