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Successful Site Selection Process for clinical trials
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Site Selection Process Confidentially agrreement feasibility questionnaire site selection visit First contact follow up site selection www.prorelixresearch.com
It is certainly not possible to mitigate all of the risk inherent in site selection. However, as in business and in life, past performance can often be indicative of future outcomes. Therefore, in the business of clinical trials, an examination of historic research site performance metrics data is an excellent starting point for sponsors and CROs to make more informed decisions on which sites have the capabilities to achieve success with a clinical trial. www.prorelixresearch.com
Access to historic and current site performance metrics trends drastically improves decision-making, allowing teams to narrow in on potential risks and hurdles sites and study teams may face. Instead of relying on assumptions or potentially over- inflated, hard-to-validate site feasibility survey responses, the research operations professionals responsible for site selection or trial delivery and execution can access reliable, tangible site performance metrics. www.prorelixresearch.com
Research professionals and executives can make more informed decisions when selecting sites for a particular study by leveraging key performance indicators such as: Start-up cycle times (“turnaround times”) Screening and enrolment performance Therapeutic expertise Physical site capabilities Patient recruitment techniques Protocol adherence www.prorelixresearch.com
Protocol Development in Clinical Trial Protocol Collectively, study-critical information which could be stored and then called up and viewed as a type of site scorecard would help in assessing potential sites in the protocol-development stage, well before the formal trial feasibility process even kicks off. www.prorelixresearch.com
Managing all this disparate site performance metrics data is clearly a challenge. If the sheer volume of data were not enough, a trove of site performance and capabilities data is often siloed in disparate systems and locations. A data-driven software as a service platform and technology acting as a centralized datahub when seamlessly integrated with other key components of a research organization’s technology stack such as clinical trial management system (CTMS) can help a research organization do the heavy lifting when it comes to storing, accessing, and displaying critical data to report and analyze site capabilities and performance metrics. Integrated, complimentary systems (CTMS) and combination allow clinical research operations professionals to capture, analyze, and share actionable data across their network or institutional footprint, including with decentralized site-based clinicians and study teams. www.prorelixresearch.com
Clinical trial protocols are only increasing in complexity. As a result, more scrutiny and pressure are placed on sponsors, CROs, and sites alike in terms of patient diversity, shortened timelines, and overall clinical trial performance and reliability. Luckily, the industry is responding to these demands with improved tools and insights to better align the right trials with the right sites. By leveraging the latest technology solutions and methods to better identify and manage site selection, feasibility, study start- up, and trial execution will also become more streamlined and efficient due to performance data transparency between the levels of clinical trial stakeholders. Ultimately, however, decreased trial cycle times and faster delivery of new therapies means patients are the real winners www.prorelixresearch.com
ProRelix Research is here for the timely execution of your projects! www.prorelixresearch.com
