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Endocrinology Case Studies
Endocrinology: Type 2 Diabetes
INC Research was contracted to deliver project management and clinical monitoring services for a 530-patient, 7- site, global type 2 diabetes study in treatment naïve patients or patients on currently one or two anti-diabetic drugs to be washout prior to study start. Special challenges inherent for the study were changes in regulatory guidelines in most of the countries except in the U.S. causing delays to the study in most countries by two to four months, combined with aggressive enrollment timelines. Several approaches were used to bring success to this project. Approaches used to bring the project forward were focused in the areas of site management, outreach programs for recruitment and recommendations regarding pre-screening. By applying unique and proactive solutions INC Research met the first patient screened and first patient enrolled milestones on time and delivered the enrollment goal two months earlier than planned.


Endocrinology: Type 2 Diabetes

INC Research provided full services including project management, clinical monitoring, data management, safety, statistics and medical writing for a global Phase II, 354 subject, 53 site, Type 2 diabetes study. The study design included background metformin therapy and an optional rollover into an open-label extension protocol. Special challenges included requested regulatory changes in sites outside the US to lower the upper limit of HbA1c which resulted in an amendment to the protocol and regulatory delays in study start-up. Proactive planning, risk mitigation and innovative approaches to ensure on time enrollment and overall project success were focused on site management and outreach programs for recruitment.

Despite the delay in start-up for sites outside the US, INC Research enrolled the first subject into the study on time. Additionally, although the enrollment timeline was significantly shortened for non US sites, once regulatory approval had been received, subjects were queued up for screening within a short period. With the complete start-up of these sites, the overall enrollment milestone was met on time; final subject visits and database also closed on time. This successful study resulted in continued Phase III development of the compound.

Case Studies

Endocrinology: Type 2 Diabetes
Endocrinology: Type 2 Diabetes