Information Library
Results for: Regulatory
To learn more about Quintiles’ services, you may broaden or narrow your search by selecting the topics at left.
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Sustainable Compliance Begins with a Strong Foundation
Brochure — December 8, 2011
The urgency of a problem often entices people to quickly focus on finding a solution and repairing the problem in order to immediately remedy the situation. -
Clinical Evaluation Medical Devices
Brochure — October 6, 2011
A Clinical Evaluation Report (CER) is a living document required for all classes of new and existing products within the EU, detailing the clinical evaluation of a product throughout its life-cycle. Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. A renewed focus by Notified Bodies on clinical evaluations, against the updated legislation, has led to a number of audit observations against manufacturers with regard to CER’s containing insufficient clinical data, or manufacturers not holding product CER’s. -
Energizing Enrollment
Case Study — October 4, 2011
The rapid recruitment for this Phase III, open, randomized, controlled, multi-center study in adjuvant triple-negative breast cancer (TNBC) was completed two months earlier than planned. -
Quintiles Names Rick Sax New Head of Integrated Clinical Services
Press Release — May 23, 2011 – Quintiles announced the appointment of Frederic “Rick” Sax as Senior Vice President and Global Head of its Integrated Clinical Services division.rograms.
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Asia-Pacific Expertise
Case Study — May 11, 2011
Quintiles' experience and flexibility to understand cultural and communication differences across Asia Pacific provided an integrated solution which exceeded recruitment targets. -
Advancing Vaccine Development in Australia and New Zealand
Case Study — April 11, 2011
Quintiles rose to the challenge of a very aggressive vaccine recruitment timeline during the holiday period - and recruited 3,000+ subjects from 18-90 years of age within just 17 days - 25 days ahead of schedule. -
Clinical Endpoint Committees
White Paper — February 22, 2011
As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs. -
Clinical – Smarter Trials, Accelerated Outcomes
Brochure — February 16, 2011
Quintiles will work with you to plan and execute the smartest clinical trials and post-marketing studies, informed by a holistic view of strategic, operational, regulatory and marketplace issues. -
Competitive Edge - Ulcerative Colitis
Case Study — February 2, 2011
Although faced with the challenge of recruiting for this small patient population, enrollment was completed two months ahead of schedule. -
Proven Precision
Brochure — February 2, 2011
Quintiles brings together – under a dedicated project manager – incredibly talented regulatory strategists, medical writers, biostatisticians, and medical, publishing and clinical pharmacology specialists who work closely together to design and implement efficient, effective submissions from beginning to end.
