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While the Biopharma market continues to face increased regulatory and cost pressures, patient safety remains top priority.
At Quintiles, our Lifecycle Safety organization has evolved with the changing safety, regulatory, and development landscape to help meet new Pharmacovigilance needs across the lifecycle from clinical through post-approval.
Capture Process Efficiencies: Between March 2011 and March 2012, our team processed 267K+ safety cases with 99% on time, and reported 59K+ cases to regulatory authorities with 99.8% on-time compliance. Learn more about the processes, expertise and technology that help us deliver high quality, timely, safety reports:
Meet PV Regulatory Expectations: At Quintiles, former regulatory agency staff and Qualified Persons for Pharmacovigilance (QPPVs) can help you manage changing global regulations and post-approval safety deliverables while gaining a deeper understanding of your benefit-risk profile. Learn more:
The result? Bring together regulatory insights and PV process expertise to deliver high quality, timely, safety and regulatory reports, ultimately saving time and costs.
At a Glance: Integrated Lifecycle Safety
At Quintiles, our Lifecycle Safety group has evolved to meet the current needs of the market to not only address these new pressures, but to help you turn them into a competitive advantage.
Post-Authorisation Safety Study (PASS)
Quintiles is a trusted partner in helping life sciences companies run PASS that meet regulatory requirements. Our experts prepare you to meet global regulatory requirements with quality cost-effective approaches and to keep apace of global regulatory reporting requirements, including the European Union Pharmacovigilance Requirements.
Podcast: An Update on Pharmacovigilance Regulations in the European Union
Deirdre McCarthy, Director of Customer Delivery with Quintiles, based in Dublin, Ireland discusses the top 5 areas of focus as you update your PV system to become compliant under the new EU Pharmacovigilance requirements.
EU and US Regulations for PV Benefit-Risk Assessments
This helpful video provides an outline of EU and US regulations on how to conduct PV benefit-risk assessments and these regulations impact your assessment framework.
Watch video/webinar excerpt
Safety Aggregate Reporting and Analytics
Quintiles' comprehensive aggregate reporting and analytics solutions, which are fully scalable and customizable, will empower you to meet increasing regulatory demands and make informed decisions about your product sooner.
Changes to the PSUR Format in the EU
In this excerpt from our full webinar “Adjusting Effectively to Meeting New European Union Pharmacovigilance Requirements,” Deirdre McCarthy will provide a summary of some of the major changes to the Periodic Safety Update Reports (PSUR) format as a result of the new regulations.
Developing Evidence for Medical Breakthroughs: Real-World & Late Phase Expertise in Rare Diseases
With the list of rare diseases across the globe expanding to nearly 7,000,1 it is critical to make new treatments available for these uncommon conditions.