Jian Chen, CEO, Peter Smilansky, SVP Product StrategyData curation, standardization, and integration have traditionally been time and resource consuming tasks when clinical information originates from numerous research participants and systems. In recent years, global regulatory requirements, advances in medical technology, and focus on monitoring and patients’ safety have brought more patients and patient-bound devices into clinical trials greatly increasing data volume and frequency of transmissions as well as introducing requirements for real-time study and patient monitoring. Biopharmaceutical companies increasingly invest in processes and information technologies to ensure continuous clinical study quality.
“Our metadata-driven technology platform, CONFORM, has been a leading clinical informatics system for 2-3 years,” states Peter Smilansky, SVP, Product Strategy, EDETEK. “This year, we have taken CONFORM to the next level with support of additional clinical research standards, automated data exchange, and event-driven processing with actionable business workflows.” Princeton, NJ based EDETEK provides configurable end-to-end solutions around clinical trial compliance, information management, and analytics. “We save time, cost, and effort in harnessing information,” says Smilansky.
CONFORM, an affordable SaaS subscription-based system, operates in the EDETEK C3 (Compliant Clinical Cloud). C3, a GxP compliant cloud, was architected utilizing Amazon Web Services (AWS) technologies. “CONFORM aggregates information received from study sponsors, CROs, laboratories, EHR systems, and connected medical devices (IoTs). With the elastic processing engine CONFORM runs in real-time,” explains Smilansky. Optimized for AWS, CONFORM applications and databases adhere to the highest level of security, often exceeding the conformance level of corporate data centers.
The latest release of the platform exhibits industry-first comprehensive events management capabilities in clinical trials. Smilansky further elaborates, “An event can be anything in the life of a clinical trial: patient enrollment, adverse event, data discrepancy, fraud indication, etc. are examples of events that we collect. Our entire system is now driven and revolves around events that trigger various tasks and workflows.” The event-driven approach of CONFORM allows collection, processing, and analysis of clinical data in real-time.
Transforming Clinical Data into Assets
The platform includes real-time and bi-directional data integration hub that provides SOA-based application integration with external clinical systems, medical IoT devices as well as human and systems workflows of CONFORM’s subscribers.
CONFORM extends existing analytical capabilities by facilitating event-based rapid medical data aggregation. For example, heart rate monitors can be integrated with the system that contains real-time analytical rules that trigger physician, patient, and sponsor’s safety system notifications due to medical conditions.
By leveraging the CONFORM platform, clinical study managers can undertake a gamut of activities such as launching, continuing, and canceling studies based on calculated in real-time safety, efficacy, and quality metrics. They can also change the course of the studies by adjusting patient enrollment, visit schedules, and treatment probability parameters based on real-time incidents.
Today, enterprises operate in multiple geographies, and certain regulatory bodies across the globe mandate them to store data locally due to patient data privacy laws. Typically, clinical systems must be installed in different regions, multiplying expenses, but it is not the case with CONFORM. “Our new upgraded system will be geographically independent. Our clients can store region-specific databases in the U.S., Europe, and Japan and still be able to analyze data together,” adds Smilansky.
To highlight one of EDETEK’s recent implementations, a large pharmaceutical company deployed CONFORM for metadata-driven cleansing, standardization, and submission of clinical data to regulators in different countries. Implementation of the cloud-based solution was rapid and achieved expected time and budget savings.
“In summary, CONFORM’s support for metadata-based study engineering and adaptive study conduct coupled with seamless geographical distribution, scalability, global availability, and real-time aggregations enable EDETEK to change the paradigm of clinical information management,” concludes Smilansky.