Reduced timeline in large pivotal phase III study
Study phase: Phase III
Type of Client: Top 10 Pharma
Therapeutic area: Obesity and drug naïve type II diabetes
Delivered: 540 randomized at 20 sites in Sweden during 10 weeks.
With all sites in one country, a centrally controlled, large scale media campaign could be utilized, and strict scheduling and follow up made it possible to reach the target with high precision within the agreed timelines.
In total 35,280 subjects with a high likelihood of type II diabetes were centrally scheduled for screening. Screening was performed by evaluation of capillary HbA1c and through a web based recruitment control system each site received immediate support regarding future scheduling of the screened subjects. By using centralized and protocol specific process solutions for recruitment of study subjects with type 2 diabetes we were able to reduce the recruitment period in this critical clinical trial significantly.
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