Delays in research have significant time and cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning.
Delays in research have significant time and cost implications and negatively impact an organization, regardless of size or financial stability. The potential for delays can be decreased or mitigated through comprehensive planning. Clinical Trial Feasibility is the best means we have for predicting the speed at which Investigators will enroll patients and how the data flow will occur over time. RDP Clinical Outsourcing routinely conducts feasibility as a stand-alone service or as part of our larger service offerings. Our Feasibility Teams are comprised of our Medical Monitor(s), Director of Operations, Feasibility Coordinator(s), and our Technical Writer(s).
Our feasibility assessments include but are not limited to:
• Investigator/Site interest
• Patient population to determine capacity and speed of enrollment
• Possible confounding factors in patient recruitment
• Availability of referral networks
• Investigator/Site experience in conducting similar trials
• Successful patient recruitment techniques
• Retrospective assessment of enrollment and retention in similar studies
• Availability of qualified site personnel
• Availability of equipment/facilities required to successfully conduct the trial
• Impact of study procedures on Standard of Care
• Additional sponsor requirements
Our critically thinking team will work with the experts within the sponsor organization to perform a thorough review of these factors. We believe this approach can yield more strategic and more productive outcomes.
At the conclusion of each feasibility assessment, a customized formal report is produced by our feasibility team that can provide insight into which sites are predicted to be the highest enrollers, how to best utilize resources, and what costs can be expected. The formal report generally contains an:
• Executive Summary
• Methods of Data Collection
• Summary of Results
• Attachment of Raw Data
While we are confident that this report can stand on its own, we also arrange for a follow-up meeting in which the sponsor team can ask questions of our team members about the findings, interactions with site personnel, and recommendations.