Navigating drug safety in the era of innovation-driven medicine
The focus on drug safety has never been more intense. Patient safety remains paramount throughout a product's lifecycle, even as sponsors and marketing authorization holders (MAHs) face increasing complexity in managing safety data. This complexity stems from huge volumes of data generated from scores of diverse sources, much of it rapidly expanding unstructured data. Innovation-driven medicine is a key factor. These dynamics are reshaping the landscape of drug safety, presenting both challenges and opportunities for innovation in pharmacovigilance practices.
The Parexel advantage
Unmatched expertise, an integrated approach
With nearly 40 years of experience in drug safety, Parexel provides the full spectrum of pharmacovigilance services, supporting product safety and patient health globally. Our team has worked on more than 3,000 pharmacovigilance projects in the past five years alone across more than 5,000 products, encompassing a multitude of therapeutic areas, including oncology, vaccines, rare diseases, and cell and gene therapies.
36+Years of experience
Our in-house experts and extensive alliance network offer tailored support to meet your specific market needs, with an integrated approach that ensures regulatory adherence and unwavering commitment to patient safety.
Cutting-edge technology and AI-powered solutions
We leverage advanced analytics and AI-enabled technology to deliver rich insights that improve patient safety outcomes and automate time-intensive processes. Our pharmacovigilance solutions are scalable and tech-platform agnostic, ensuring adaptability to evolving IT landscapes. Parexel’s in-house safety technology team continually evaluates and implements cutting-edge automation solutions to adapt to evolving landscapes and empower you to meet future challenges head-on.
Our capabilities include:
- AI-driven case intake with multi-lingual processing
- Advanced case management with cloud-based Oracle Argus Safety Database
- AI-empowered global and local literature surveillance
- Real-time analytics with customizable dashboards
- Cutting-edge signal management and risk assessment tools
- AI-powered periodic reporting and authoring solutions
- Automated reconciliation for clinical and marketed studies
Our pharmacovigilance solutions have yielded remarkable outcomes, including up to 25% gain in authoring several aggregate report sections, 34% gain in ICSR narrative compilation, and 20 to 50% efficiencies in global and local literature reviews.
Global reach
Our global safety expert team includes more than 3,000 safety professionals, with well over 250 safety physicians and 350+ medical writers, across 12 operational safety hubs in strategic locations, including Europe, the United States, Latin America, and Asia.
> 5,000products supported
We have longstanding relationships with 8 of the top 10 pharma companies globally, supporting diverse pharmacovigilance solutions for over 5,000 products in more than 3,000 studies and completing over 2,000 post-marketing engagements.
Comprehensive services
Parexel provides comprehensive services including safety program oversight, risk management, and regulatory compliance. Our drug safety physicians excel in medical review of Individual Case Safety Reports (ICSRs), aggregate reports, and signal management, as well as extensive support of Safety Medical Sciences, instilling rigorous product stewardship. Our expert team of safety medical writers author high-quality safety documents and reports encompassing aggregate, signal management, risk management, and health authority responses. We also offer clinical endpoint adjudication (CEA) and data monitoring committee (DMC) services as a critical component of clinical trials.
Our complete range of drug safety and pharmacovigilance services include:
- ICSR management from case intake to submissions for all types and sources and across a range of safety databases
- Aggregate report authoring for all types and complexities
- Global and local literature search and review
- Signal detection and surveillance
- Local affiliate support
- Safety Medical Sciences risk management and benefit-risk assessments
- Safety/brand physician product stewardship
- Consulting services, including safety strategy development, training support and technology roadmap support and implementation
- Robust and cost-effective pharmacovigilance solutions for Japan and China
- Safety database hosting, implementation and migration
- Medical information call center services
- Qualified Person for Pharmacovigilance (QPPV) and signal evaluation services
- Clinical endpoint adjudication (CEA) and data monitoring committee (DMC) services
36 years of experience in safety services
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products supported
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million ICSRs in the last four years
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studies
Our experts in safety and pharmacovigilance
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