Drug Safety &
Risk Management

Expertly navigate every aspect of risk mitigation and regulatory compliance, while prioritizing patient safety

End to end services for various pharmacovigilance aggregate reports for more than a decade across all regions including US, UK, EU, Japan, China and other APAC countries

>1100
DSURs
>550
PBRERs/ACOs
>290
RMPs
>2000+
SUSAR LL Brief Reports

Solutions

Targeted Safety Evaluation

Established Product Safety & Efficiency

Clinical Development Phase

Development Safety Update Reports (DSURs)
Semi Annual SUSAR Reports
Risk Management Plans (RMPs)
(EU & Core)
Safety Modules of eCTD: Addendum To Clinical Overview (ACO)

Regulatory Filing Strategy & Submission

Risk Management & Long-Term Safety

Marketing Phase

Periodic Benefit Risk Evaluation Reports/Periodic Safety Update Reports (PBRERs/PSURs)
Periodic Adverse Drug Experience Reports (PADERs)
Regional Periodic Reports: China-PSURs, 120-Day Safety Update Reports
United States Periodic Reports (USPRs)
Benefit-Risk Assessment (BRA)
European Public Assessment Reports (EPARs)
RMP Update
Preparation & Updates to Labelling Documents (e.g. CCDS, CCSI, SmPC, USPI, etc.)

Therapeutic Focus Areas in DSURs

Key Strengths

Global Pioneer in DSUR

  • First DSUR submitted by SIRO in 2011, within 30 days of ICH E2F guideline implementation
  • Over 1100 DSURs submitted with no queries from health authorities

Core Experts in Risk Management Plan

  • Specialized team for EU and Core RMP to leverage efficiencies in authoring, technical review and QC for all types of regulatory submissions

Innovation

  • Day minus 90 implementation of aggregate reports
  • Experience in SOPs and templates development for various safety reports adhering to regulatory guidelines

Dedicated Experts Across All Major Therapeutic Areas

  • Proficient across all major Therapeutic Areas, scientific review of aggregate reports by team of specialized physicians

Automation

  • SIRO is focused on integrating technology enablers, like Robotic Process Automation, to enhance our industry-leading solutions
  • We continuously monitor trends to adopt AI technologies when they become stable and effective for pharmacovigilance purposes
Case Studies
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RSI consolidation for a Vaccine DSUR

This pharmaceutical major that offers a wide range of therapeutics, read more

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Country specific DSUR

This pharmaceutical major that offers a wide range of therapeutics, read more

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DSUR for Co-developed product

This pharmaceutical major that offers a wide range of therapeutics, read more

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