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The clinical development landscape for endocrinology and diabetes drugs is changing as new regulatory guidance continues to evolve.
Trial requirements are increasing timelines, development cost and data complexity. Now more than ever, it is critical to have an ally who understands these implications and can take your product through development to market success.
Track record in global diabetes research studies and endocrinology research.
In the past five years, Quintiles has provided services for more than 165 diabetes clinical research studies involving more than 148,800 subjects and more than 19,200 investigator sites in 61 countries.
In the past three years, we have worked on close to 90 endocrinology research studies involving approximately 29,000 patients in 52 countries. The wide variety of indications in this therapeutic area include obesity, calcium disorders (osteoporosis), growth hormone disorders (including acromegaly) and pituitary hormone disorders (including hyperprolactinemia and hyperthyroidism).
Diabetes and Biomarkers
In clinical studies, there is often uncertainty in how much weight to place on biomarker results versus clinical outcomes. This article discusses how the judicious use of biomarkers in the drug development process can bring all the goals of drug approval process into alignment. Read journal article
New FDA Guidance on Antidiabetic Therapies
The new emphasis on assessing cardiovascular risk for diabetes patients is the latest turn in the FDA’s focus on diabetes drug development. To help you identify the full implications of the 2008 FDA Guidance on antidiabetic therapies on your development plans, two of our top experts in diabetes and cardiac safety have teamed up to take a closer look at the FDA’s recommendations. Read white paper