A study-specific eCOA library and supporting quality management program significantly reduces clinical trial startup timelines

PHILADELPHIA, June 29, 2021 /PRNewswire/ -- Signant Health, the leader in evidence generation for modern clinical trials, today announced a new acceleration program that reduces study setup timelines by 50% or more without compromising the quality of clinical data generated or the scientific impact of Signant's in-house therapeutic area expertise on study outcomes.

Developed and validated with client feedback for a series of CNS studies, the program builds on Signant's rich, 20-year heritage in evidence generation for neurology research, including the first-ever use of eCOA in an Alzheimer's disease trial. While validated in CNS studies, the acceleration program can be applied to any therapeutic area to maximize efficiency in study startup processes for traditional, hybrid, or decentralized trials.  

At the core of the program is the creation and maintenance of a library of electronic clinician-rated outcome assessments that have undergone Signant's robust equivalence testing and clinical user acceptance testing processes. Using a "front-loaded" approach to planning and design during the study setup phase, Signant leverages its eCOA science expertise to develop a protocol-specific library of translated and validated eCOA scales which can be administered on site or remotely, as well as a standardized data management plan for each scale, an enduring rater training plan with a special focus on remote assessments, and a central rater network.

To maintain the highest quality standards for complex clinician-reported outcomes, the program includes two crucial considerations. First, it is overseen by Signant's industry-leading science and medicine team who guide the clinical trial set up phase and remain closely involved in all phases of trial administration, ensuring continuity in quality from planning to study launch through closeout. Secondly, Signant's proprietary Blinded Data Analytics solution proactively and objectively monitors study outcomes in real time, offering a means to identify and mitigate quality concerns that could compromise study data reliability if left unaddressed.

"This latest development represents a paradigm shift in our industry," said Sanjiv Waghmare, Signant's chief product officer. "By developing a robust eCOA library up front and supporting it through a comprehensive clinical rater and data quality management program, we can improve efficiency and reduce startup timelines without compromising quality, especially for decentralized trials which are now widely accepted and normalized since the COVID pandemic. In launching this program, we are reinforcing Signant's commitment to serving sponsors, patients, families, and sites by accelerating the clinical development process while generating highly accurate, reliable data to help sponsors deliver life-improving treatments and therapies faster."

Since the introduction of the industry's first eCOA solution for Alzheimer's in 2013, it has been Signant's mission to ensure that measures of cognition and function in dementia clinical studies are scored and administered to the highest standards. At the 2021 Alzheimer's Association International Conference (AAIC), Signant Health will be presenting information and posters demonstrating how its eCOA and Endpoint Reliability solutions positively impact the quality of data in multiple pivotal studies. AAIC will be held on July 26-30, 2021, both virtually and on site in Denver, Colorado.

About Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.

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