Data Standards Archives

Blog

Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?

June 27, 2024 Advances in technology and changes to the regulatory environment have resulted in…

CertaraJune 27, 2024

Guide

A Best Practice Guide to CRF Design

Design quality, effective and reusable case report forms with our CRF Design Guide. Download the…

CertaraJune 7, 2024

Blog

Demystifying CDISC, SDTM, and ADaM

Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…

CertaraMay 22, 2024

Blog

Leveling Up SDTM Validation with the Magic of Data Managers

In this abstract, Julie Ann Hood and Jennifer Manzi look at how you can improve…

CertaraMay 19, 2024

Case Study

How one university overcame practical and cultural challenges to implement CDISC compliance

A US-based university with a nationally recognized academic health center implemented Clinical Data Interchange Standards…

CertaraMay 8, 2024

Blog

What Should a Clinical Metadata Repository Do?

April 4, 2024 As the clinical research industry moves towards more efficient and automated processes, clinical…

CertaraApril 4, 2024

Blog

What’s Driving the Increased Demand for SEND Dataset Services?

Gain an understanding of CDISC SEND dataset creation challenges impacting the biopharma industry, and how…

CertaraMarch 29, 2024

Blog

Everything You Need to Know About CRFs in Clinical Trials

Read about the basics of CRFs and eCRF design, why annotated CRFs should be standardized…

CertaraMarch 26, 2024

Blog

Everything You Need to Know About SDTM

Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…

CertaraMarch 12, 2024

Blog

Best Practices for a Successful eCTD Submission

Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…

CertaraMarch 5, 2024

Data Standards

Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?

A Best Practice Guide to CRF Design

Demystifying CDISC, SDTM, and ADaM

Leveling Up SDTM Validation with the Magic of Data Managers

How one university overcame practical and cultural challenges to implement CDISC compliance

What Should a Clinical Metadata Repository Do?

What’s Driving the Increased Demand for SEND Dataset Services?

Everything You Need to Know About CRFs in Clinical Trials

Everything You Need to Know About SDTM

Best Practices for a Successful eCTD Submission

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