Drug and device developers have to meet specific and demanding clinical safety requirements. With an understanding of these demands, our specialists and consultants design drug/device safety and pharmacovigilance services to exactly fit the specific and unique needs of your individual product or study —with an agile and flexible approach that allows us to adapt as a development program or project evolves.

Full-Service Clinical Study Support

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 programs start with a safety database at the study level and decide later in development to invest in a global safety database. Take the steps to pool all safety data into one safety database and dataset, you can better optimize signal detection and risk/benefit assessments.

The Premier 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’s pharmacovigilance specialists work with our regulatory and medical writing teams to provide flexible consulting support for short-term and limited-scope projects, including:

• Qualified Person for Pharmacovigilance (EU)
• Aggregate report writing
• PV SOP and procedure writing
• Authoring 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 PV and Device Safety advice

At Premier, our materiovigilance and pharmacovigilance services can be seamlessly integrated as part of a full-service clinical trial or provided as a standalone solution. Contact Premier today to discuss your clinical program and we’ll tailor a strategy that best suits your unique needs.