Data Mapper transforms study metadata into draft SDTM and ADaM specifications, accelerating one of the most time‑consuming steps in clinical reporting. Once specifications are finalized, Data Mapper's ...
A universal skills package for querying CDISC clinical data standards (SDTM, ADaM, CDASH, Controlled Terminology) directly from the CDISC Library API. Works with any AI agent that supports the ...
本記事は、PhUSE EU Connect (2025)の資料の一つ、From Standards to Strategy: Customizing CDISC Open Rules for TMF Reference Modelの紹介です。 COREの用途は主としてSDTMやADaMデータセットのチェックです。しかし ...
임상시험 수탁기관(CRO) 업무 현장에서 목격되는 현실은 신약 개발 과정 개선의 필요성을 깊이 있게 통찰하게 한다. 규제기관의 복잡한 요구사항과 현장의 현실적인 한계 사이에서 균형을 ...
Read how patient-centric care models and pharma innovation are ushering new trends in life sciences to improve patient outcomes and enrich lives. TCS ADD™ is a suite of modern and open technology ...
CDISCが主導するオープンソースプロジェクトの一つにCORE(CDISC Open Rules Engine)があります。このテキストでは、COREとは何か？その意義について考えてみます。 CORE＝バリデーター？ 最も単純で ...
Continuous medical and safety monitoring of subject data during a clinical trial is a critical part of evaluating the safety of trial participants and as such is governed by protocol procedures and ...
The conect4children (c4c) project aims to facilitate efficient planning and delivery of paediatric clinical trials. One objective of c4c is data standardization and reuse. Interoperability and ...
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