EDETEK

EDETEK Inc. is a premier provider of digital clinical trial computer systems, offering innovative technology platforms and related clinical services to pharmaceutical, biotechnology, and medical device companies. Headquartered in Princeton, New Jersey, EDETEK delivers a next-generation R&D Cloud ecosystem designed to revolutionize clinical development by fostering interoperability, enhancing collaboration, improving data quality, and accelerating regulatory submissions.

With a proven track record spanning 763+ global clinical trials supported, more than 120 active customers, and partnerships with over 50% of top pharmaceutical companies, EDETEK has established itself as a global leader in clinical development informatics. The company has supported more than 50 regulatory submissions to agencies including the FDA, EMA, PMDA, CFDA, Health Canada, and Australia's regulatory authority.

R&D Cloud Ecosystem

• EDETEK's R&D Cloud provides a scalable, flexible, and reliable environment for clinical development, built upon two core platforms: CONFORM™ and eClinical Suite.
• Clients can select specific services they need, including integrations with third-party products, to create a tailored enterprise R&D Cloud solution.
• The ecosystem enables seamless integration of end-to-end capabilities with secure collaboration and workflow among internal and external stakeholders.

CONFORM™ Platform

• Orchestration and Collaboration Manager
• SSO Manager
• Data Integration Gateway
• Intelligent Metadata Hub
• Clinical Data Lake
• Statistical Computing Environment
• Study Analysis and Submission
• Clinical Data Pipeline
• Clinical Study Quality Management, Review and Analytics (Information Quality – IQ)

eClinical Suite

• Clinical Trial Management System (CTMS)
• Electronic Data Capture (EDC)
• eDiary / ePRO / eCOA
• Risk Based Quality Management (RBQM)
• Randomization & Trial Supply Management (RTSM)

Clinical Services

• Biostatistics and Programming: High-quality statistical analysis and data programming solutions supporting clinical trials from design through regulatory submission.
• Study Development: End-to-end support for the planning, design, and execution of clinical trials, including development of scientifically sound and regulatory-compliant study protocols to accelerate drug development.
• Medical Writing: Clear, accurate, and regulatory-compliant documentation to support clinical development and regulatory submissions, helping companies effectively communicate study results with precision.
• Clinical Data Management (CDM): End-to-end solutions ensuring the integrity, accuracy, and compliance of clinical trial data from start to finish, optimizing efficiency while meeting regulatory standards.
• eClinical Operations: Seamless execution and management of clinical trials, ensuring efficiency, compliance, and data integrity with end-to-end operational solutions for smooth study conduct.

AI and Innovation

• EDETEK has launched Ensemble, an AI Managed Services offering designed to simplify the adoption of artificial intelligence and accelerate clinical development.
• The company has developed an AI-driven Clinical Development Ecosystem, reflecting its commitment to automating and innovating clinical development informatics.
• EDETEK has presented at major industry events, including the 44th Annual J.P. Morgan Healthcare Conference, underscoring its prominence in the life sciences technology sector.

EDETEK's best-in-class, modular approach allows life sciences organizations to build a customized R&D Cloud tailored to their specific enterprise needs, combining powerful technology platforms with deep clinical expertise to simplify, innovate, and automate the delivery of new treatments to patients.