What’s New for SEND 2023
This webinar will focus on several changes to the CDISC SEND standard that became active…
Danielle Pillsbury2023 年 6 月 12 日
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program
Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…
Danielle Pillsbury2023 年 6 月 1 日
SEND Dataset Quality Control: Best Practices & Recommendations
In this blog, Senior Product Management Director Peggy Zorn explores best practices & recommendations for…
Certara2023 年 4 月 25 日
Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints
可以使用再利用的数据和高级分析来验证替代终点。A surrogate…
Jim Gallagher2023 年 4 月 13 日
LABO: Data utilisation and data infrastructure in drug development: Data, Data, Data
Published: 2023 年 4 月 12 日 This is the German article written by Dr. Fabian Rauscher, Scientific…
Certara2023 年 4 月 12 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…
Danielle Pillsbury2023 年 2 月 9 日
The eCTD Submission Process: Tips and Tricks for Drug Development Success
Our experts compiled the tips and best practices you need to know for a successful…
Jim Gallagher2022 年 11 月 22 日
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
Becca Bucci2022 年 6 月 3 日
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
Becca Bucci2022 年 6 月 2 日
P21 Adds Support for CDISC Open Rules Engine (CORE)
P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available…
Certara2022 年 4 月 25 日
