EDETEK Launches BioStat.AI: The Industry's First Unified AI Platform for Clinical Data, Biostatistics, and Programming

Precision, Speed, and Insight—Redefined by BioStat.AI

PRINCETON, N.J., Sept. 2, 2025 /PRNewswire/ -- EDETEK Inc., a global leader in digital clinical platforms and services, proudly announces the launch of BioStat.AI, a groundbreaking AI-powered solution that unifies Clinical Data Management, Biostatistics, and Statistical Programming into a single, intelligent platform. BioStat.AI is the latest innovation within EDETEK's R&D Cloud ecosystem, designed to accelerate clinical development with unmatched precision, automation, and regulatory readiness.

A Strategic Leap in Clinical Data Science

BioStat.AI is built on the foundation of EDETEK's flagship platforms, CONFORM™ and eClinical, and leverages advanced AI technologies including large language models (LLMs), machine learning, and predictive analytics. Through agentic AI, the platform will enable seamless orchestration of data workflows, statistical analysis, and decision-making, all within a secure, scalable environment.

"BioStat.AI represents a major leap forward in how clinical data is managed, analyzed, and submitted," said Jian Chen, CEO of EDETEK. "By embedding AI across the entire statistical lifecycle, we're empowering sponsors and CROs to make faster, smarter, and more compliant decisions, without compromising quality or control."

BioStat.AI empowers clinical development teams with a comprehensive suite of advanced capabilities, including AI-driven, automated statistical analysis planning (SAP) and Submission-Ready Dataset and Statistical Analysis Generation & Validation. The platform also facilitates the creation of Clinical Study Reports (CSRs) and patient narratives enriched with regulatory intelligence. Additionally, BioStat.AI integrates real-world evidence (RWE) to support post-approval surveillance, ensuring a seamless and data-driven approach across the clinical trial lifecycle.

"BioStat.AI is more than a platform and it's a strategic enabler," added Dr. Shakthi Kumar, Chief Strategy & Business Officer at EDETEK. "It unifies three critical domains, clinical data, biostatistics, and programming, into a single AI-powered engine. This allows our clients to streamline operations, reduce cycle times, and elevate the quality of their regulatory submissions."

Modular, Scalable, and Ready for the Future

BioStat.AI is fully integrated with EDETEK's R&D Cloud, allowing clients to configure their environment with modular capabilities and third-party interoperability. It can also be seamlessly deployed on top of existing operational environments with other third-party platforms in a secure cloud environment, ensuring flexibility and rapid adoption across diverse enterprise infrastructures.

Proven Business Impact

For a wide range of use cases such as SAP development, SDTM and ADaM dataset creation, statistical programming, CSR assembly, and others, targeted benchmarks estimate that BioStat.AI when used along with EDETEK's R&D Cloud can deliver 40–90% improvements in operational efficiency and 40–60% reductions in overall reporting costs. These results highlight BioStat.AI's ability to significantly accelerate timelines, reduce manual effort, enhance submission quality, and improve predictability across the clinical development lifecycle.

For more information or to request a demo, visit www.edetek.com.

About EDETEK, Inc. Founded in 2009, EDETEK is an innovative clinical solutions company that provides high-quality Artificial Intelligence-powered technology platforms and related clinical services to pharmaceutical, biotechnology, and medical device companies. With a global presence across four continents and serving clinical development globally, EDETEK's commitment to excellence remains unwavering as it serves over one hundred biopharmaceutical companies.

SOURCE EDETEK, Inc.