On August 2, 2019, India's Tata Consultancy Services (TCS) has launched Advanced Drug Development (ADD) Site Feasibility Platform, which will provide 'life sciences companies with a single, integrated platform that digitizes the site selection and activation processes, and facilitates data-driven decision-making while assessing site feasibility for multi-site clinical trials.' Performing a thorough assessment of clinical trial feasibility is an important early step in initiating global clinical trials, particularly in rare disease or pediatric studies where country selection, site selection and patient recruitment each represent a significant challenge to successful clinical trial conduct. Feasibility Analysis. The purpose of Feasibility Analysis is to evaluate studies involving human subjects for feasibility. If required by your Division, Department, or Organization, PIs, Sub-Investigators, or Study Coordinators may conduct a Feasibility Analysis using the UCSF Clinical Trial Feasibility Checklist tool. For industry trials, you may complete the “Sponsor Expectations” section of the checklist and include any additional information as appropriate.

• Feasibility In Clinical Research
• Site Feasibility Questionnaire Clinical Trial
• Conducting Feasibility In Clinical Trials

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).

Selection of the right investigator sites and the target patient population are key to conducting smarter clinical trials. Clariness has developed two clinical trial feasibility assessment tools which are used to better predict investigator performance and understand patient response for studies, before they start.

Feasibility In Clinical Research

Site Feasibility Questionnaire Clinical Trial

Patient surveys are often used to pre-identify prospective trial participants and test draft protocols. Questionnaires address:. Inclusion/exclusion criteria. Therapy schedules. Treatment. Willingness to participate in clinical trials Responses can also be used to better understand a “day in the life of” patients with specific condition or diseases to optimize patient care or compliance support needs over the course of a trial.

Conducting Feasibility In Clinical Trials

Clariness’ feasibility screener assesses investigator sites’ suitability for a given trial, based on protocol inclusion and exclusion criteria. Insights gained from the feasibility screener provide:. Recognition of critical inclusion/exclusion criteria. Predictions of screening failure and drop out rates, based on patient feedback to protocol/therapy. Prediction of recruitment rates.

Identification of non-performing and high performing sites prior to initiation. Calculation of the number of sites required to complete the study on time, or more accurate calculation of study duration Select Clariness to get a head start on your study planning with our clinical trial feasibility assessment tools.