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. This guide covers benefits like data standardization and faster CRF design.

40 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. This deep dive explains its metadata-driven architecture and use of CDISC

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 the SDTM and ADaM data models, their structure, and use in regulatory submissio

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.

40 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