What’s New for SEND 2023 On-Demand Webinar What’s New for SEND 2023 This webinar will focus on several changes to the CDISC SEND standard that became active…CertaraJune 12, 2023
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program Case Study 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…CertaraJune 1, 2023
SEND Dataset Quality Control: Best Practices & Recommendations 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
Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints Case Study Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints Repurposed data and advanced analytics can be used to validate a surrogate endpoint. A surrogate…CertaraApril 13, 2023
LABO: Data utilisation and data infrastructure in drug development: Data, Data, Data Press Coverage LABO: Data utilisation and data infrastructure in drug development: Data, Data, Data Published: April 12, 2023 This is the German article written by Dr. Fabian Rauscher, Scientific…CertaraApril 12, 2023
Data Visualization with SEND Data to See What Happened at the Preclinical Phase On-Demand Webinar 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…CertaraFebruary 9, 2023
The eCTD Submission Process: Tips and Tricks for Drug Development Success White Paper 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…CertaraNovember 22, 2022
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry Case Study 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…CertaraJune 3, 2022
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Case Study 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…CertaraJune 2, 2022