— Presentation Demonstrates the CONFORM™ Bioinformatics Digital Platform —
EDETEK Inc., a leading global provider of specialized software and services for the biopharma, devices, and diagnostics industries, announced today that it will present at the 2024 The Society for Clinical Data Management (#SCDM24) conference. This presentation, entitled “360-Degree Continuous Study Monitoring,” takes place during The Product Showcase Program in Room G, on Tuesday, October 1, 2024, at 2:15pm EDT at the OMNI Boston Hotel at the Seaport.
“Our technology provides an innovative digital platform that continuously monitors data quality, conformance, safety, and efficacy,” said Peter Smilansky, Senior Vice President, Product Development and Strategy, EDETEK, Inc. “This unprecedented level of data orchestration ensures proactive risk management and swift identification of anomalies. EDETEK, then, can help ensure quality submissions, lower development costs, and a faster track to revenue.”
This presentation will provide attendees with a comprehensive overview and demonstration of the power of CONFORM™. CONFORM is a powerful, purpose-built software platform that positively impacts the speed and quality of clinical trial execution by providing the ability to connect, collect, and consume clinical trial data while conforming to state-of-the industry standards and regulations all in one, seamless, integrated solution. CONFORM delivers a comprehensive, fully integrated end-to-end platform for the clinical trials of the future.
“This robust and intelligent approach provides real-time oversight of clinical data and operational aspects of trials,” explains Michele Cherry, Vice President, Product Support, and Implementation, EDETEK, Inc. “Our CONFORM Informatics digital platform offers a dynamic view of trial activities, enhancing decision-making and operational efficiency. It’s the next level in transforming clinical data oversight, minimizing risks, and maximizing trial success.”
CONFORM is designed to support clients from preclinical data development, through all regulatory phases of drug development, up to and including supporting data submission to all global regulatory authorities (e.g., FDA, EMA, PMDA, Health Canada, etc.). CONFORM features can be customized and tailored for any size client. Some sponsors need all the myriad of elements that CONFORM has to offer. And larger clients can choose those services and integrate them into their in-house systems.
“EDETEK is laser-focused on delivering protocol required patient data with the highest quality and integrity,” said Jian Chen, CEO, EDETEK, Inc. “EDETEK delivers world-class technology efficiencies and process best practices, and our expert teams orchestrate real time data access across multiple trials.”
CONFORM provides sponsors the ability to transfer large volumes of data in near real-time and delivers expandable storage capacity, flexible workflows with transformations, mappings, validation, search, and flagging capabilities. CONFORM also ensures full data lineage and improved quality, due to proactive monitoring of data acquisitions and the ability for multiple stakeholders to quickly access and review data. It performs secure data exchange while maintaining HIPPA, 21 CFR Part 11 and GDPR compliance.
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