EDETEK, the premier provider of digital clinical trial computer systems, today announced that the company’s cloud-based eClinical and clinical informatics platforms CONFORM™ are supporting multiple clinicals sponsors in research and development of emergent COVID-19 treatments and vaccines.
Jian Chen, EDETEK’s President and CEO, “Our customers use CONFORM ™ in Phase I, II and III COVID-19 clinical trials. In some trials our Platform is used entirely as an end to end clinical system. Customers also implemented selective CONFORM™ components to add efficiency to the existing development workflows. It is exciting to see how rapidly our team and the system can fit into the emergent research and development of the COVID-19 therapies and vaccines. We have invested years in development of the state of the art comprehensive and highly configurable clinical system and I am thrilled to see how it is helping scientists battle the global pandemic”.
The CONFORM™ eClinical suite of study conduct applications is utilized for patient randomization, clinical supply, trial and document management, drug safety monitoring and electronic data capture. CONFORM™ Informatics platform enables rapid ingestion of clinical structured and unstructured data from a variety of clinical data providers, data aggregation, validation, transformation, review and reporting in one system that quickly integrates with information consumers – processes and systems of study sponsors and sites. In the case of COVID-19, CONFORM™ studies were configured, tested, and deployed in a matter of days to meet the highly challenging timelines of clinical development teams.
CONFORM™ was architected to support modern clinical trials that concurrently use variety of systems to collect information. EDC, laboratory systems, instruments, IoT patient wearable devices, imaging, ePRO smart phones, EHR applications represent a typical set of digital sources in a trial. COVID-19 trials employ many of these data providers to study different safety and efficacy indicators in record time.
“Using the capabilities of our Information Hub and Clinical Data Lake to quickly connect and aggregate the data were keys in these implementations. Another main differentiator of CONFORM™ is the event driven model. CONFORM™ is fully event driven and it processes any business and scientific events as well as data loads in real time according to sponsors’ workflow and study configuration. The durability, near real time performance and quality of data collection, processing and analysis are instrumental in our daily operations and it is enormously important in the COVID-19 studies where we receive tens of thousands of data transmissions every day and run complete study data processing and reporting tasks several times a day. The era of a slow-going typical EDC study with a nightly processing batch is gone. COVID-19 has shown us that the traditional model is no longer working”, states Peter Smilansky, Senior Vice President of Product Development and Strategy of EDETEK.
CONFORM™ GxP–compliant technology platform is natively designed for scalable cloud computing. It runs on Amazon Web Services supporting COVID-19 and hundreds of other clinical trials on three continents.