Orchestrated AI delivered as a service for measurable impact

PRINCETON, N.J., Jan. 14, 2026 /PRNewswire/ -- EDETEK Inc., a global leader in digital clinical platforms and AI powered solutions, today announced Ensemble, a comprehensive AI Managed Services offering designed to help sponsors operationalize validated, human supervised AI across clinical development. This launch coincides with EDETEK's presentation at the 44th J.P. Morgan Healthcare Conference, underscoring the company's commitment to driving innovation in clinical development.

Ensemble by EDETEK delivers production grade AI that is validated, integrated, human supervised, and easy to consume. It brings together best fit models, agentic automation, and domain experts across biometrics, data management, medical monitoring, and regulatory affairs, all delivered as an inspection ready managed environment with SLAs. Outputs at scale include SAPs, SDTM and ADaM datasets, TLFs, CSRs, protocol adherence alerts, and audit trail reviews, supported by a risk-based Computer Software Assurance approach and 21 CFR Part 11–compliant controls.

"Our clients do not need another pilot; they need results," added Dr. Shakthi Kumar, Chief Strategy & Business Officer. "Ensemble brings together the entire AI stack with dynamic model orchestration, secure hosting, and agentic workflows, all supported by our biometrics and regulatory expertise. This means clients can adopt and scale AI without worrying about managing multiple technologies, compliance requirements, or operational complexity."

"With Ensemble, sponsors can finally consume AI as a managed capability that blends technology with deep functional expertise," said Jian Chen, Chief Executive Officer of EDETEK. "It is a practical path to measurable impact that accelerates timelines, strengthens compliance, and improves quality from first study to portfolio scale."

What makes Ensemble different

• Full stack AI, orchestrated for clinical workflows: Best fit LLMs, LMMs, and micro models are optimally chosen, with RAG retrieval and end to end evaluations to balance correctness, safety, latency, and cost. Human-in-the-loop workflows across Data Management, Statistics, Medical Monitoring, and Regulatory Affairs approve outputs before use.
• Managed, sovereign deployments: Delivered in the cloud or private AI region/factory patterns, including on premises and air gapped options to preserve data residency and IP while enabling modern AI services and hardware.
• Validation and compliance built in: CSA aligned validation kits and policy guardrails, with auditability and change control to support inspections and global regulatory expectations.
• Biometrics and functional services at the core: Deterministic, Human-in-the-loop workflows produce SAPs, SDTM/ADaM, TLFs, and CSRs at scale turning AI into tangible deliverables sponsors can trust.

Industry Certifications

EDETEK's platforms and services meet the highest level of industry certifications, including:

• ISO 27001:2022 – Information Security Management Systems (ISMS)
• ISO 27701:2019 – Privacy Information Management System (PIMS)
• ISO 27017:2015 – Code of Practice for Information Security Controls for Cloud Services
• ISO 42001:2023 – Artificial Intelligence Management System (AIMS)

These certifications underscore EDETEK's commitment to security, privacy, compliance, and responsible AI management.

Why sponsors need it now

Clinical development faces data fragmentation, interoperability gaps, model credibility and validation needs, and clinician burden when tools do not fit real SOPs. Ensemble addresses these barriers by unifying standards-based data pipelines such as CDISC, prebuilt adapters for ingestion to analytics and reporting, context of use documentation, and role specific human in the loop checkpoints, all packaged as a consumable service with SLAs.

EDETEK is keen to engage in discussions with client sponsors and CROs about how Ensemble can accelerate their clinical development.

About EDETEK

Founded in 2009, EDETEK provides AI powered platforms and clinical services to pharmaceutical, biotechnology, and medical device companies worldwide. The company serves more than one hundred and twenty biopharma clients across four continents with a focus on innovation, interoperability, and quality in clinical development. EDETEK's platforms and services have supported over fifty successful regulatory filings.

Disclaimer: This release may include statements regarding future plans, strategies, and anticipated benefits of EDETEK's platforms and services. These statements are based on current expectations and are subject to change without notice.

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SOURCE EDETEK, Inc.