Drug Safety and Pharmacovigilance
Focusing on quality in global drug safety and pharmacovigilance services
Our safety and pharmacovigilance teams support clinical trial and post-marketing safety surveillance across the globe. With patient safety as the critical component in clinical development, our quality focus aligns us to partner with our customers to provide both standalone and integrated services throughout the lifecycle of a product.
What sets us apart is our people: highly qualified drug safety scientists and skilled healthcare professionals with experience in direct patient care, industry-specific pharmacovigilance services and a deep knowledge of regulatory legislation and dedication to providing quality safety services.
…Your meticulous record-keeping and knowledge of our pharmacovigilance processes and systems afforded us the time and flexibility to widen our bandwidth to provide drug safety and support to other areas and groups in the company and the industry.
Midsize Biopharmaceutical company
How do we meet the challenges of global drug safety and pharmacovigilance?
We forge a long-term, trusting relationship and provide a personalized service customized to your needs. No two customers are alike, and our philosophy is to shape our support to best fit your needs and structure. Across the board, we’re focused on offering effective solutions for compliant and accurate global pre- and post-approval pharmacovigilance.
Whether you’re looking for full safety services or standalone elements, we can implement innovative solutions in global drug safety and pharmacovigilance.
Syneos Health offers the following safety and pharmacovigilance services to support Phase I, through product authorization to post-marketing to ensure quality and compliance:
Clinical Trial Safety: Phase I-IV, full processing from data entry to case closure, including aggregate report writing and submissions.
Post-Marketing Safety: Case processing, reporting, signal detection, literature search and review, safety writing (e.g. PBRER, PADER, RMP), EU QPPV, PSMF creation and maintenance, risk management strategy and minimization, local safety support.
Safety Submissions: Dedicated subject matter experts in safety regulatory legislation and submissions with access to a regulatory intelligence database.
Safety Physician: Dedicated/trained physicians in all aspects of the life cycle of safety and pharmacovigilance, including risk-management expertise.
Safety Database: Dedicated support team with in-house Oracle Argus expertise and experience with client safety systems.
Safety Call Center: Provides services for ADR intake, product quality complaint intake, medical information request handling and outbound phone call follow-up.
We have one of the largest Safety and Pharmacovigilance teams in the industry, working across the globe, for you.
Each project is supported by a team of pharmacovigilance professionals located strategically to support specific requirements. Local staff support regulatory reporting as required, to ensure compliance. We follow global processes for consistency across the team, regardless of location.
Our people possess strong academic backgrounds, comprising pharmacists, medical doctors, nurses and life-science graduates. During the 25+ years of our safety operations, our teams have developed a deep knowledge of legislation and broad industry experience.
We achieve a compliance rate of >99% in on-time safety reporting in a constantly evolving regulatory environment.
In recent years, pharmacovigilance legislation has become more stringent than ever, dramatically changing the game for compliance. Reporting needs to be significantly more robust and specialized, and as a result customers are increasingly outsourcing safety and pharmacovigilance services. We can provide:
- Automated safety report distribution system with pre-programmed regulatory reporting requirements. Adaptable, secure and controlled delivery of expedited and periodic reports to regulatory authorities, ethics committees and investigator sites with full tracking and audit trail
- A multi-tenant, fully validated, 21-CFR part 11 and E2B compliant safety database system, generating standard regulatory reports, with the flexibility to be customized to meet your specific requirements
- Dedicated regulatory safety intelligence team with access to a regulatory intelligence database allows for continuous monitoring of regulatory requirements across the globe
