The new eDiary solution optimizes data quality and simplifies epilepsy trial participation
Signant Health, the leader in evidence generation for modern clinical trials, introduced today a novel electronic diary (eDiary) data capture solution designed to simplify the experience for patients and research sites participating in epilepsy trials while ensuring robust outcome assessment data to support trial endpoints. Developed in collaboration with The Epilepsy Study Consortium (TESC), the new patient-reported outcome measure offers clinical research sponsors and organizations a standardized solution to capture common seizure-data elements with high-quality data.
Epilepsy-related protocols often require study teams to collect data about patients’ daily and episodic seizure events, typically captured using paper-based or non-standardized electronic diaries. The new electronic seizure diary solution, consisting of two pre-designed, configurable eDiaries, enables sponsors to harness the benefits of electronic data collection and standardize their measurement approach to the assessment of seizure events.
For example, research teams can adapt the eDiary’s features to accommodate specific study requirements while maintaining a common data set structure, thus ensuring full adherence to protocol and regulatory requirements as well as promoting participant adherence and retention.
“We chose Signant as a partner based on their considerable experience developing complex eDiaries and conducting epilepsy trials,” said Jacqueline French, President and Founder of The Epilepsy Study Consortium. “This new electronic seizure diary combines scientific best practice with clinical requirements to ensure capture of robust and relevant clinical outcome assessments.”
In its mission statement for the diary development initiative, The Epilepsy Study Consortium outlined several unique challenges associated with clinical data capture in epilepsy trials that it sought to address, including differing needs for pediatric and adult populations, questions about the frequency of data collection, and methods for addressing data changes or corrections.
“Until now, there hasn’t been a standardized seizure diary,” noted Lew Fredane, M.D., Signant’s Clinical Vice President, Neurology, and therapeutic-area leader. “We have deployed electronic data capture solutions for more than 50 epilepsy trials, so we knew that it would be critical to accommodate the unique needs of epilepsy trial participants who include not just adult and pediatric patients, but their caregivers and study partners as well.”
Signant’s scientific experts and software development architects worked closely with TESC and partners for over a year to ensure the resulting eDiary solution streamlines the participation experience for everyone involved in epilepsy trials, offers a link between at-home patients’ experience and clinical monitoring to facilitate prompt intervention as needed, and generates high-quality data essential for meeting regulatory requirements.
The electronic seizure diary, available now, can be deployed on the company’s flagship Signant SmartSignals eCOA platform.
About the Epilepsy Study Consortium
The Epilepsy Study Consortium (TESC) is a group of scientific investigators from academic medical research centers who are dedicated to accelerating the development of new therapies in epilepsy to improve patient care. The organization’s goals include building a partnership between academics, industry and regulatory agencies and optimizing clinical trial methodology in order to responsibly speed new treatments to patients. Visit www.epilepsyconsortium.org to learn more.
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 capture, aggregate, and reveal 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 Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.
Source: prnewswire.com, Signant Health