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 enrolments rate and therefore successful planning of trial milestones is impossible. If your last trial was delayed by recruitment issues, you may wish to consider the level of detail you were provided with in the feasibility assessment.
Moreover, CROMSOURCE strongly believes in “Quality by Design”: a determination to review from the very beginning all aspects of operations, with a view to proactively identify and prevent quality issues and operational threats rather than relying solely on the ability to react to issues when they arise. A detailed and reliable feasibility analysis is one of the crucial first steps in the process.
For these reasons, CROMSOURCE have developed our unique Feasibility PlusTM approach which is provided without obligation at the RFP stage to potential sponsors. This stringent methodology is the foundation of our ability to deliver our End-to-End Guarantee.
Working closely with our sponsors, CROMSOURCE identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are then reviewed and timeliness developed for each country to ensure fast regulatory approvals.
CROMSOURCE then works directly with the most professional and productive sites in each geography. Sites are only considered if they have proven they can deliver a combination of high enrolment, high retention, and quality data.
Further, each site is requested to identify potential patients far in advance of study start-up, thus assuring there are no surprises during the enrolment phase.
With the accurate and detailed trial planning data provided by Feasibility PlusTM CROMSOURCE can offer Sponsors a comprehensive End-to-End guarantee, assuring them that their study will be completed on time and on budget with no CRO initiated changes in scope.
Our Feasibility Plus process is such a valuable tool that CROMSOURCE are often requested to assist clients with rescuing trials which are delayed due to poor recruitment. We implement Feasibility Plus as part of our Expert Trial Rescue service.