Blog Archives

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Maximizing Oligonucleotide Therapeutic Development: How They Work

This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest…

CertaraMay 7, 2021

Blog

Planning a Health Canada PRCI Compliant Submission

How to set yourself up for a successful Health Canada PRCI submission

CertaraApril 26, 2021

Blog

Controlled Terminology Best Practices

Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve…

CertaraMarch 3, 2021

Blog

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy…

CertaraFebruary 22, 2021

Blog

Why Consistency in Patient Safety Narratives is Crucial

“You would not be able to tell 40 different writers were authoring these. It looked…

CertaraFebruary 9, 2021

Blog

8 Tips for Successfully Developing Oligonucleotide Therapies

By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of…

CertaraFebruary 1, 2021

Blog

Be Honest, Be Reliable, Be Human: Insights from a Global Drug Development Expert

One of the most exciting things about working in the pharmaceutical industry is the ability…

CertaraDecember 16, 2020

Blog

Formatting Annotated Case Report Forms (aCRFs): Not Submitted Annotations and SDRG

Simplify aCRFs with insights on “Not Submitted” annotations, reviewer’s guide tips, and define origin column…

CertaraNovember 13, 2020

Blog

Preparing CDISC Submissions for China’s NMPA

China’s NMPA now accepts CDISC submissions. To support this initiative, Pinnacle 21 has released a…

CertaraOctober 30, 2020

Blog

Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms

Streamline aCRF formatting by mastering versions, repeated pages, and compliance essentials. Read the third blog…

CertaraOctober 9, 2020

Blog

Maximizing Oligonucleotide Therapeutic Development: How They Work

Planning a Health Canada PRCI Compliant Submission

Controlled Terminology Best Practices

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

Why Consistency in Patient Safety Narratives is Crucial

8 Tips for Successfully Developing Oligonucleotide Therapies

Be Honest, Be Reliable, Be Human: Insights from a Global Drug Development Expert

Formatting Annotated Case Report Forms (aCRFs): Not Submitted Annotations and SDRG

Preparing CDISC Submissions for China’s NMPA

Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms

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