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
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
How to Navigate the FDA Landscape for an Orphan Drug
Rare diseases are a public health priority. FDA has launched several programs and a final…
CertaraFebruary 21, 2024
Dose Optimization Considerations for Targeted Radiation Therapies
The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio…
CertaraFebruary 16, 2024
Navigating Market Access for Healthcare Products: The Power of the Global Value Dossier
This blog defines the global value dossiers and explains how BaseCase can support creating interactive…
CertaraJanuary 24, 2024
Understanding the Role of Your Discovery Asset’s Target Product Profile
If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly…
CertaraJanuary 19, 2024
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…
CertaraDecember 12, 2023
Key Lessons from the 2nd Annual FDA ASCO WORKSHOP on Getting the Dosage Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies
Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and…
CertaraNovember 17, 2023
The “Animal Rule” – What if a clinical trial simply isn’t ethical?
Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy. Sometimes, the…
CertaraNovember 10, 2023
Can’t ChatGPT Do That? Practical Applications for AI in Drug Discovery & Development
Explore how Certara.AI tackles the limits of generalized GPTs like ChatGPT to transform drug discovery,…
CertaraOctober 31, 2023
