CROMSOURCE believes that a rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrollment rate and therefore successful planning of trial milestones is impossible, which in turn compromises the success of the trial.
For these reasons, CROMSOURCE developed our unique Feasibility PlusTM approach.
Working closely with our clients, CROMSOURCE identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are then reviewed and timelines developed for each country to ensure that regulatory approvals will permit adherence to the project timelines. CROMSOURCE then works directly with the most suitable sites in each geography. Sites are only considered if they have proven they can deliver a combination of acceptable enrollment, high subject retention, and data quality. Further, each site is requested to identify potential patients in advance of study start-up, thus increasing the likelihood of meeting enrollment targets.
Our Feasibility PlusTM process is such a valuable tool that CROMSOURCE is often requested to assist clients with rescuing trials that are delayed due to poor recruitment.