Learn more about Endocrinology

Endocrinology

Navigating the challenges as an ally to drive your development

We can be your partner to mitigate the effects of longer timelines, additional costs, and higher risk in your clinical development program. Coupling our deep experience with therapeutic expertise across our commercial, consulting and capital groups, our focus goes beyond the clinical trial to ensure your product gains market access and reaches physicians and patients worldwide.

Since 2000, our endocrinology team has conducted more than 350 trials, enrolling more than 225,000 patients with conditions including:

  • Diabetes
  • Obesity
  • Calcium disorders (Osteoporosis)
  • Growth hormone disorders (including acromegaly)
  • Pituitary hormone disorders (including hyperprolactinemia and hyperthyroidism)

Our medical and clinical experts understand the clinical development challenges in these areas and can work with you to ensure your plan is strategic, efficient, and effective.

Experts in diabetes clinical development in a new regulatory environment

New regulatory guidance has altered the clinical development landscape for anti-diabetic therapies. Length and trial requirements have extended, increasing the cost of development and complexity of data requirements. It is critical, now more than ever, to have an ally who understands the implications throughout the product lifecycle to:

White Paper

New FDA Guidance on Antidiabetic Therapies

Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program.

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Peer-Reviewed Article

Journal for Clinical Studies

In the January 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the FDA Guidance on diabetes drugs and cardiovascular risk.

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White Paper

EMA’s Guidance on New Antidiabetic Drug Development

Assessing the EMA’s Guidance on New Antidiabetic Drug Development In January 2010, the European Medicines Agency (EMA) issued a draft guideline on antidiabetic drug development

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Peer-Reviewed Article

Regulatory Landscapes for Future Antidiabetic Drug Development

In the March 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the EMA Guidance on diabetes drugs and cardiovascular risk.

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Position Paper

Diabetes Proactive Proposal

New FDA Guidances On Antidiabetic Therapies Change the Landscape of Drug Development. How Quintiles Can Help You Navigate the Guidances and Successfully Develop Pipeline Drug Candidates.

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