Expert Pharmacovigilance & Drug Safety Analytics

Patient safety is at the heart of everything we do. Our pharmacovigilance services help pharmaceutical companies and regulators monitor, detect and assess adverse drug reactions using real-world data from both primary and secondary care, ensuring medicines remain safe for patients across the UK, USA and globally.

What We Do
  • Adverse event detection and signal identification from real-world data
  • Post-market safety surveillance using EHR, GP and hospital claims data
  • Risk-benefit analysis and safety reporting
  • Support for regulatory submissions (MHRA, EMA, FDA)
  • Disproportionality analysis and data mining
  • Integrate primary care prescribing data with secondary care outcomes for complete safety monitoring

Data Sources We Use
  • GP prescribing and clinical records: primary care adverse event monitoring via EMIS, SystmOne and Vision
  • Hospital Episode Statistics (HES): secondary care outcomes and adverse event identification
  • Linked primary and secondary care data: connecting prescribing with outcomes for complete safety surveillance
  • CPRD Aurum & Gold: gold-standard pharmacoepidemiology data
  • US health data: for international drug safety studies
  • Yellow Card and spontaneous reporting databases: regulatory signal detection

Who We Support
  • Pharmaceutical and biotech companies
  • Contract Research Organisations (CROs)
  • Regulatory affairs teams
  • Academic pharmacovigilance researchers
  • US and international pharma partners

What You Get
  • Signal detection reports
  • Regulatory-grade safety documentation (MHRA, EMA, FDA)
  • Risk management recommendations
  • Publication-ready safety analyses
  • Integrated primary and secondary care safety reports