Safety Management

We deliver end-to-end safety management services throughout the clinical development lifecycle, ensuring regulatory compliance, patient safety, and operational efficiency.

Safety Database Expertise

  • Proficient in global pharmacovigilance platforms including Oracle Argus and ArisG
  • Guidance on database selection, setup, and optimization based on evolving sponsor requirements
  • Integration support with clinical data management systems and safety workflows
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Case Processing & Safety Reporting

Comprehensive management of Adverse Event (AE) and Serious Adverse Event (SAE) cases from all sources:
  • Interventional & Non-Interventional Studies
  • Safety signals reporting

Literature Search & Screening

  • Experienced Literature Review Specialists with over 15 years
  • Execution of systematic searches to identify ICSRs and relevant safety data
  • Local PV teams screen non-indexed regional journals to meet global and local regulatory obligations

Regulatory Submissions

  • Regulatory compliance with CDSCO, EMA, FDA, and other health regulators
  • Coordination with investigator sites, IRBs, and ethics committees

Signal Detection & Risk Management

  • Signal detection and management in accordance with Good Pharmacovigilance Practices (GVP) Module IX
  • Structured approach to signal validation, prioritization, escalation, and regulatory communication

Aggregate Safety Reporting

Full-cycle development of:
  • Development Safety Update Reports (DSURs)
  • Periodic Safety Update Reports (PSURs / PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)

Medical Monitoring

Ensure subject safety, regulatory compliance, and clinical integrity

Key services:
  • Continuous medical oversight from study start-up to close-out
  • Data review and subject eligibility confirmation
  • Proactive communication with sites
  • 24/7 clinical support for safety events
  • Input on protocols, CRFs, informed consent forms, and safety plans
  • Therapeutic expertise across a wide range of clinical indications
  • Training and guidance to clinical and investigator site teams

We deliver high-quality, reliable, and responsive pharmacovigilance and safety management solutions tailored to your clinical program's needs.