Learn how to create CDISC domains in minutes with PK Submit
Creating CDISC domains as part of the pharmacokinetic (PK) deliverable for regulatory submissions can be…
Certara2023 年 3 月 1 日
Understanding Europe’s New Clinical Trial Regulations (EU-CTR)
While the new EU-CTR will help to streamline clinical trials, which will benefit both patients…
Certara2023 年 2 月 27 日
Common Clinical Trial Disclosure Challenges & Potential Solutions
Pharmaceutical companies are being required to be more transparent through the timely disclosure of more…
Certara2023 年 2 月 24 日
RAPS Sponsored: How Drug Developers Can Navigate the Inflation Reduction Act
The Inflation Reduction Act (enacted in August 2022) contains profound changes for the healthcare and…
Certara2023 年 2 月 10 日
Data Visualization with SEND Data to See What Happened at the Preclinical Phase
SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation…
Certara2023 年 2 月 9 日
Podcast interview with Dr. Elvira Müller. EU joint HTA – decided, but how will it be executed and how should companies prepare
In Europe, there are at least as many reimbursement assessment processes in place as European…
Certara2023 年 2 月 7 日
FDA awards new grants to support developing & assessing complex generic drugs
Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) Simulator is being used to verify and expand biosimulation models…
Certara2023 年 2 月 7 日
Artificial Intelligence: What is it & how can it accelerate rare disease drug development?
Large & complex information streams present opportunities for the AI data scientist to aid in…
Certara2023 年 2 月 3 日
