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Safety & Pharmacovigilance

Safety monitoring services tailored precisely to your needs

Biotech companies have specific and demanding clinical safety requirements. Because we’re Built for Biotech℠, our consultants and specialists design safety and pharmacovigilance services that exactly fit your product’s and study’s needs – and we’re agile and flexible enough to adapt as they do.

Study-Specific Services

We manage the clinical safety process from triage through case processing, narrative writing, and submission to competent authorities and ethics committees, supported by a comprehensive framework of standard operating procedures (SOPs) and study-specific safety plans. Our services include:

  • Medical triage of serious adverse events
  • Case processing
  • Narrative writing
  • Medical review and assessment
  • Risk/benefit assessments
  • Submissions to competent authorities, ethics committees, and sites
  • Development safety update report writing
  • Signal detection

Portfolio Services

Many of our biotech customers start with a safety database at the study level and later decide to invest in a global safety database. By pooling all the safety data into one safety database and one dataset, we can better optimize signal detection and risk/benefit assessments. The Premier Consulting team can manage the migration of all your portfolio safety data into a dedicated global safety database while maintaining and archiving your data for as long as needed.

Consulting Services

Even the best safety team can benefit from additional support, so Premier Consulting’s pharmacovigilance consultants and specialists work with our regulatory and medical writing teams to provide flexible solutions for short-term and limited-scope services, including:

  • Aggregate report writing
  • PV SOP and procedure writing
  • Risk management plans
  • Literature searches and reports
  • Inspection readiness audits
  • Preparation of reference safety information
  • Risk/benefit statements
  • Medical review of individual case study reports
  • Signal detection
  • General consulting and regulatory advice

Contact us to learn how you can benefit from our safety and pharmacovigilance expertise.