Articles tagged with “cdisc”

What is a CRF Library? A Guide for Clinical Trials

Learn what a Case Report Form (CRF) library is and how it improves clinical trials. Covers CDASHIG v2.1, ODM-XML v2.0, Veeva Vault EDC, Medidata Designer AI, and the FDA Dataset-JSON RFC (Apr 2025).

45 min read

12/14/2025

case report form library crf design clinical trials data standardization electronic data capture (edc)cdisc clinical data management good clinical practice (gcp)

OpenStudyBuilder: Metadata-Driven Clinical Study Design

Explore OpenStudyBuilder, the open-source platform for clinical study specifications. Updated for 2026 with ICH M11 adoption, CDISC 360i launch, USDM 4.0, and growing multi-company collaboration.

35 min read

12/13/2025

openstudybuilder cdisc clinical study design metadata repository digital data flow sdtm open source clinical trial automation

A Guide to CDISC Standards: Understanding SDTM and ADaM

Learn the essential CDISC standards for clinical trial data. This guide explains SDTM and ADaM data models, their structure, regulatory requirements, and 2025-2026 updates including SDTM v3.0, Dataset-JSON, and ICH M11.

40 min read

11/19/2025

cdisc sdtm adam clinical data standards clinical trials regulatory submission data mapping fda

CDISC Standards: How They Work with SDTM & ADaM Examples

Learn about CDISC standards for clinical trial data. This guide explains SDTM, ADaM, CDASH, and Define-XML with concrete examples for regulatory submissions.

45 min read

11/14/2025

cdisc sdtm adam clinical trial data data standards regulatory submission cdash define-xml clinical data management

Clinical Trial Phases 1–3: A Comprehensive Guide for Pharmaceutical IT Professionals

A practical guide to clinical trial phases 1–3 for pharma IT: objectives, compliance, costs, and IT infrastructure for modern drug development.

20 min read

5/14/2025

clinical trial phases pharma IT regulatory compliance EDC CTMS FDA guidance GCP CDISC drug development