EDETEK Unveils Innovative Platform for Clinical Trial Oversight
EDETEK Introduces a New Era in Clinical Trial Data Management
EDETEK Inc. is setting the stage to revolutionize clinical trial data oversight with its advanced CONFORM™ Bioinformatics Digital Platform. As a leader in delivering specialized software and services to the biopharma, medical device, and diagnostics industries, EDETEK is gearing up to showcase its innovative approach at a prominent conference.
Showcasing at the Society for Clinical Data Management Conference
During the 2024 Society for Clinical Data Management conference, EDETEK will present an engaging session entitled "360-Degree Continuous Study Monitoring." This comprises part of The Product Showcase Program, where attendees will witness first-hand the capabilities of the CONFORM™ platform.
Peter Smilansky, Senior Vice President at EDETEK, emphasizes the technology's cutting-edge features: "Our platform constantly monitors data quality and conformance, leading to proactive risk management and quick anomaly detection." This service is vital not only for maintaining data integrity but also for facilitating faster and more efficient submissions to regulatory authorities.
Understanding the CONFORM™ Platform
CONFORM™ stands out as a comprehensive solution tailored for the nuanced needs of clinical trials. This platform unifies the process of connecting, collecting, and analyzing clinical data while adhering to state-of-the-art industry standards. Such integration enhances both the speed and quality of trial execution, paving the way for the future of clinical trials.
Michele Cherry, Vice President of Product Support at EDETEK, underlines the significance of the platform in transforming clinical trial experiences. She states, "Our CONFORM Informatics platform equips sponsors with a dynamic overview of trial activities, boosting decision-making processes and improving operational efficiency." Through this information flow, EDETEK aims to minimize risks and maximize trial success rates.
Benefits for Sponsors and Clients
One of the most compelling features of the CONFORM™ platform is its versatility, capable of supporting clients at every stage of clinical data development. From preclinical data gathering to assisting in submissions to global regulatory authorities, the platform can adapt its functionality according to the needs of various sponsors.
Jian Chen, CEO of EDETEK, expresses a strong commitment to data integrity when he says, "We focus on delivering protocol-required patient data with the utmost quality. Our esteemed teams ensure that real-time data access is seamlessly orchestrated across multiple trials." This dedication underlines EDETEK's stance as a reliable partner in the biopharma sector.
Enhancing Data Management Efficiency
CONFORM™ offers sponsors an efficient solution to manage substantial volumes of data almost instantaneously. Its expandable storage capabilities, coupled with flexible workflows for transformation and validation, enable a comprehensive approach to data handling. The proactive monitoring features ensure stakeholders can quickly access, review, and respond to data changes.
Moreover, CONFORM™ adheres to stringent compliance requirements, including HIPAA, 21 CFR Part 11, and GDPR. This focus on security plays a crucial role in today's data-sensitive environment.
About EDETEK
Since its inception in 2009, EDETEK has been at the forefront of providing cutting-edge clinical solutions to a diverse clientele in the pharmaceutical and biotechnology spaces. With a robust workforce of over 450 employees across four continents, the company's unwavering commitment to quality and efficiency means it has gained the trust of over 100 biopharmaceutical companies worldwide.
Engaging with the Community
If you're attending the Society for Clinical Data Management conference, be sure to connect with EDETEK at booth #500. The EDETEK team welcomes the opportunity to discuss how its advanced platforms can benefit your clinical data management needs.
Frequently Asked Questions
What is the focus of EDETEK's CONFORM™ platform?
The CONFORM™ platform focuses on real-time oversight of clinical trial data management, enhancing data quality and ensuring compliance with regulatory standards.
When and where will EDETEK present its new platform?
EDETEK will present at the Society for Clinical Data Management conference, showcasing the CONFORM™ platform during The Product Showcase Program.
What are the key benefits of using CONFORM™?
CONFORM™ offers improved data monitoring, proactive risk management, and swift anomaly identification, significantly enhancing the efficiency of clinical trial processes.
Who can benefit from EDETEK's services?
EDETEK's services are tailored for biopharma companies, medical device manufacturers, and any organization involved in drug development, from preclinical phases to regulatory submissions.
What compliance standards does CONFORM™ meet?
CONFORM™ is designed to ensure compliance with HIPAA, 21 CFR Part 11, and GDPR, facilitating secure data management in clinical trials.
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