Safety & Pharmacovigilance
Our experienced global pharmacovigilance professionals help you ensure safety through all stages of clinical development.
Safety monitoring services tailored precisely to your needs
Biotech companies have specific and demanding clinical safety requirements. Because we’re Built for Biotech℠, we design safety and pharmacovigilance services that exactly fit the needs of both your product and study – and we’re agile and flexible enough to adapt as they do.
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
Many of our biotech customers start with a safety database at the study level and later make the decision to invest in a global safety database. By pooling all of the safety data into one safety database and one dataset, we’re able to better optimize signal detection and risk/benefit assessments. Premier Research 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 you need.
Even the best safety team can benefit from additional support, so Premier Research’s pharmacovigilance experts 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
Safety considerations for emerging therapies
Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies.
Special considerations for medical device trials
To ensure the safety and efficacy of these devices, regulators expect device manufacturers to provide data that accurately reflect the risk profile of the device. As such, the regulatory guidelines for devices are distinct from those governing drugs, particularly in the area of safety.