Data Standards Archives

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

Blog

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

In this blog post, we explore the top 10 things you need to know about…

CertaraOctober 17, 2023

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

CertaraSeptember 21, 2023

Conference

CDISC China Interchange

CertaraAugust 17, 2023

Blog

SEND Dataset Quality Control: Best Practices & Recommendations

In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for…

CertaraApril 25, 2023

Data Standards

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

10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions

Maximizing Reusability for Drug Submissions to Different Health Authorities

CDISC China Interchange

SEND Dataset Quality Control: Best Practices & Recommendations

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