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Women's Health Case Studies

Women's Health: Oral Contraceptive

INC Research managed an oral contraceptive study for a major pharmaceutical company that included 63 U.S. sites and 1,356 subjects. The INC team completed 33 on-site selection visits in four weeks and 63 site initiation visits in 10 weeks. The time of protocol approval to first patient in was 60 days, while the industry average is 131 days. Site contracts, IVRS, and regulatory document collection were completed within 12 weeks of project award. Enrollment was met in five months (one month before the target date). Sixty-one of 63 sites successfully enrolled with a data query rate of only 4.2%. INC Research is in the process of enrolling an additional 400 subjects for the amended protocol.
 

Women's Health: Oral Contraceptive Trial

INC Research Women’s Health unit’s outstanding performance in completing a Phase II endometrial safety study for a large pharmaceutical company led to the award of a Phase III oral contraceptive trial. 1,756 subjects at 84 sites, in a 3 arm protocol were enrolled. Time from protocol approval to first patient enrolled was 60 days, exceeding the industry average of 131 days. Site contracts and regulatory document collection were completed within 12 weeks of project award. Enrollment was completed 1.5 months early, and all sites were closed on time. The team processed over 160,680 paper diaries and CRF pages in meeting the database lock date.
 

Women's Health: Symptoms Associated With Menopause Trial

INC Research Women’s Health unit’s outstanding performance in completing a Phase II study led to the award of 2 Phase III trials with the same sponsor. In the Phase II, women were required to follow a stringent protocol including both observation and run-in periods, weekly visits, and two sets of daily diaries. All timelines were met or exceeded, including having the first patient, first visit early. Due to the quality performance of the study team and deliverables, the sponsor awarded 2 Phase III trials as a non-compete award. The Phase III trials are ongoing, and will enroll 1068 subjects in 12 months at 70 sites. 

Case Studies

Women's Health: Oral Contraceptive
Women's Health: Oral Contraceptive Trial
Women's Health: Symptoms Associated With Menopause Trial