Critical timeline shortened

Study phase: Phase II

Type of Client: Biotech Company

Therapeutic area: Hypercholesterolemia

Delivered: 180 randomized at 12 sites in Sweden during 2 months.

The study was on the critical timeline for the drug development, which made a very fast recruitment essential.  Protocol and patient feasibility was performed, revealing that the recruitment could be performed in one country alone. As a single country setup would reduce the complexity with logistics, monitoring, etc, this was selected as the preferred method. Due to the short calendar time-lines and a long run-in phase before randomization, enrolment needed to be completed before the first patient was randomized.  With detailed scheduling and follow-up of the recruitment progress, the strict timelines were held and study result was delivered on time.

For this study, mass-media recruitment was used and sites were selected based on patient availability in the site geographic area. Centralized booking to site schedule with continuous follow-up made it possible to make necessary adjustments to recruitment activities during execution. Before recruitment started, a detailed protocol and patient feasibility was performed to make it possible to prognosticate number of enrolled patients to reach the required number of randomized patients.

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