Just as the endocrine system is complex, so is the conduct of clinical research to develop drugs to treat the broad range of diseases and disorders of the endocrine system. Let us make it easier for you.

We have a dedicated endocrinology group and clinical operations team. Together they have years of experience working on global trials across this diverse spectrum of endocrine indications. With this wealth of therapeutic and regulatory experience, we are able to take a strategic approach to full clinical plan development. And that means the scientific rigor of a specific program is always front of mind. 

Our use of web-based electronic endpoint adjudication systems and innovative monitoring techniques, along with our strong links to academia and access to huge patient populations, means we can help your product achieve the success it deserves. 

Our endocrinology clinical study experience includes:

  • Diabetes and diabetic complications
  • Obesity
  • Metabolic syndrome
  • Growth disorders
  • Dyslipidemia
  • Hypogonadism
  • Rare metabolic diseases

Our endocrinology work in practice

Background

Requested regulatory changes in sites outside the US resulted in an amendment to the protocol and regulatory delays in study start-up for a global, Phase II, 354 subject, 53 site, Type 2 diabetes study, including background metformin therapy and an optional rollover into an open-label extension protocol.

Solution

We provided full services including project management, clinical monitoring, data management, safety, statistics and medical writing.

Result

Despite the delay in start-up sites outside the US, we enrolled the first subject into the study on time. The overall enrollment milestone was met on time and final subject visits and database lock were completed on time. This successful diabetes study resulted in continued Phase III development of the compound.

Let us help your product achieve the success it deserves.

 

a This is an estimate of INC Research studies from the last five years that are completed or scheduled to complete for this therapy area.