High performing sites in cardiovascular study

Four studies were awarded by a pharma organisation over a period of less than two years, with overlapping start-up through close out timelines. Indications included Hyperlipidemia, CAD, and Type 2 Diabetes, which meant that sites could be used across multiple studies within the program, allowing for greater efficiency and consistency in approach.

Milestone expectations were aggressive, requiring an innovative approach and rapid start-up.

ICON made the decision to appoint multiple sites in Accellacare to benefit from access to streamlined and established processes. This also enabled greater ability to access potential patients through the electronic health records of two million active patient lives as a result of the site network’s unique partnerships with healthcare systems and community physician practices. Both pre-screening and patient enrollment were quicker because of this unique access.

To further compress start-up timelines, ICON conducted face-to-face central SIVs for multiple sites located in the same vicinity for all four studies, to enhance communication and collaboration.

The study achieved all study milestones on or ahead of schedule, and Accellacare performed better than industry and study level average.

Measurable outcomes included:

• Decreased costs (direct and pass through) of onsite initiation visits
• Increased engagement of sites as a result of in person meetings
• Reduced timelines in site activation: Mean timeline from final protocol to site activation ranged from 14-32 days less for Accellacare vs. non-owned sites across the study program

Consistency in delivery and milestone achievement across the program

• Study 1: Represented 22% of the total screening sites on this trial, achieved the first 15 screened and first 10 randomised subjects
• Study 2: Represented 29% of the total screening sites on this trial, achieved first patient in, and 8 subjects screened in the first recruitment week came from 4 different sites
• Study 3: Represented 70% of the total screening sites on this trial, achieved the first 69 subjects screened across 8 sites
• Study 4: Represented 35% of the total screening sites on this trial, achieved the first 4 subjects screened on the trial, the 2nd-5th first randomised subjects