Services
Pharmacovigilance consulting services
Senior drug safety support, scoped to your stage: from a defined piece of work to interim leadership of your safety function.
Safety strategy and interim leadership
For companies that need senior safety expertise before, or alongside, a full in-house team.
- Product safety strategies for development programmes, new indications and combinations
- Interim Head of Drug Safety or part-time safety leadership
- Assessment of current safety resources and capabilities, and team build-up plans
- Safety input to clinical development plans and study design
- Safety due diligence for in-licensing and acquisitions
Signal management and benefit-risk
Documented, reproducible evaluation of emerging safety information, from ongoing trials to the post-marketing setting.
- Set-up and review of signal detection and management processes in line with GVP Module IX
- Signal validation and medical evaluation of emerging safety profiles
- Benefit-risk assessments and review of competitor safety profiles
- Toxicity management guidance and combination safety assessments
- Safety input to independent data monitoring committees (IDMCs)
Risk management
Risk management that is proportionate, regulator-ready and workable in practice.
- EU Risk Management Plans: safety specifications and RMP updates
- US REMS strategy and design
- EU additional risk minimisation measures, including pregnancy prevention programmes
- Effectiveness evaluation planning for risk minimisation
Regulatory filings, aggregate reports and Health Authority interactions
Safety leadership for global submissions and the documents that support them.
- Safety strategy and integrated safety analyses for filings in the EU, US, China and the rest of the world
- Strategy and medical review of aggregate reports (DSUR, PSUR/PBRER)
- Reference safety information and Core Data Sheet input
- Responses to safety questions from Health Authorities, Ethics Committees and IRBs
PV system, quality and inspection readiness
Keep your pharmacovigilance system compliant, documented and inspection-ready.
- PV system gap assessments against GVP requirements
- Pharmacovigilance System Master File (PSMF) set-up, improvement and maintenance
- PV QA support: audit preparation, CAPA follow-up and inspection readiness
- Mock inspections and inspection-day support
- Review of PV agreements and vendor oversight
PV training and education
Training that helps teams make better-documented safety decisions.
- In-house workshops for safety, clinical and medical teams
- Training on signal management, risk management and appraisal of safety evidence
- Self-paced courses, slide decks and templates in the online shop
Not sure where to start
A short call is usually the quickest way to scope what you need.