Cardiovascular Case Studies |
Cardiovascular: Hypercholesterolemia Program
In a global program, INC Research managed four primary hypercholesterolemia studies across seven countries. Due to our ability to manage large pools of global resources (91 team members-26 in-house personnel and 65 field CRAs), to provide strong communication and consistency on a global stage, and to maintain oversight of overlapping timelines, we were able to successfully plan, execute and lock the entire program on-time. The INC Research team worked in tandem with our client and vendors to lock five databases (304 sites, 2419 subjects, 167,210 eCRFs) within six months.
Cardiovascular: Outcome Study
INC Research recently completed a large scale cardiovascular outcome study involving 300 sites in 16 countries. Approximately 9800 randomized patients (enrolled within the planned timelines) were followed for more than 5 years. The INC Research team built excellent relationships with all site personnel to ensure motivation and participation over the 5 year study period. Various strategies to retain patients were successfully implemented, resulting in an 81% retention rate. Creative operational initiatives included the development of a trigger system to plan monitoring visits according to actual work on site (i.e. not based on CRFs completed), thus achieving efficient use of budgeted site visits. Close collaboration between the clinical and safety team members ensured timely closure of 11,197 total SAEs and Outcome events. Final study visits for all patients were completed within a three month period, and data collection and query resolution were achieved on time due to advance planning and the efforts of the dedicated team.
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Case Studies
Cardiovascular: Hypercholesterolemia Program
Cardiovascular: Outcome Study
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