The conduct of clinical research is undergoing a paradigm shift towards more streamlined and cost-effective collation of the right high-quality data to answer the critical questions. In this brave new world, Quality Assurance is becoming ever more important, moving from a focus on detecting and fixing problems to a new focus on preventing them. Wider Perspectives has the breadth and depth of experience to help you navigate these changes at a strategic or tactical level. See our Services page for details.
Since 2002 we have provided expert Quality Assurance consulting services to pharmaceutical, biotechnology and medical device companies and implemented effective assessments of processes for auditees in over 50 countries around the world. We have supported the successful registration of multiple pharmaceutical products by enabling sponsors to clear the hurdle of regulatory authority inspections. We were privileged to be involved in the inspection readiness preparations that resulted in CHMP approval of the Western World's first gene therapy product.
Our Principals’ experience in Good Clinical Practice, gained during more than 30 years each in the pharmaceutical industry, ranges from first-in-human studies to product registration trials and post-marketing surveillance, and spans a wide variety of therapeutic areas.
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