# EDETEK

> EDETEK is a privately held clinical technology and services company serving pharmaceutical, biotechnology, medical device, and clinical research organizations. Its R&D Cloud combines CONFORM data processing and analytics with eClinical trial applications, supported by biometrics, data management, programming, and managed AI services.

- **Founded:** 2009
- **Headquarters:** Princeton, United States
- **Founders:** Jian Chen (Founder, President and CEO)
- **Products:** CONFORM, R&D Cloud, eClinical Suite, BioStat.AI, Ensemble
- **Notable:** CONFORM platform released in 2016., January 2026 company announcement reports support for over 50 successful regulatory filings., January 2026 announcement reports ISO 27001:2022, ISO 27701:2019, ISO 27017:2015, and ISO 42001:2023 certifications.

## Products & services

- **CONFORM** — Metadata-driven clinical informatics platform covering ingestion, storage, standardization, review, analytics, statistical computing, and submission.
- **R&D Cloud** — Configurable ecosystem combining CONFORM, eClinical, collaboration, and third-party integrations.
- **eClinical Suite** — Trial applications including EDC, CTMS, patient-reported outcomes and assessments, RBQM, and randomization and trial supply management.
- **BioStat.AI** — Announced AI platform combining clinical data management, biostatistics, and statistical programming, including planning and reporting capabilities.
- **Ensemble** — Managed AI services with domain experts, validation controls, model orchestration, and human approval of outputs.
- **Clinical and biometrics services** — Clinical data management, biostatistics, programming, standards development, medical writing, study development, and eClinical operations.

## Achievements

- CONFORM platform released in 2016.
- January 2026 company announcement reports support for over 50 successful regulatory filings.
- January 2026 announcement reports ISO 27001:2022, ISO 27701:2019, ISO 27017:2015, and ISO 42001:2023 certifications.
- Medidata enterprise partnership announced in November 2023.

## Latest updates

- **2026-07** — Announced sponsor partnership program supporting preparation for the FDA real-time clinical trials initiative; FDA alone determines participation.
- **2026-01** — Launched Ensemble managed AI services with validation and human supervision.
- **2025-09** — Announced BioStat.AI for clinical data, biostatistics, and programming.
- **2025-06** — Engaged Capgemini for transformation and AI engineering.

## Links

- Website: https://edetek.com/
- LinkedIn: https://www.linkedin.com/company/edetek/
- Twitter/X: https://twitter.com/EDETEK_INC

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Profile page: https://yespress.io/edetek
Published by YesPress — https://yespress.io
Last updated: 2026-10-02