Exploring Common CDISC ADaM Conformance Findings
March 27, 2025 ADaM data are required by the FDA and PMDA and accepted by…
CertaraMarch 27, 2025
Introducing the new Certara.com: Transforming drug development for good, together.
March 26, 2025 We’re thrilled to introduce the launch of our revamped website and refreshed…
CertaraMarch 26, 2025
Centers of Excellence in Pharma: Driving Efficiency and Innovation
March 25, 2025 In today's fast-paced pharmaceutical industry, Centers of Excellence (CoEs) have become vital…
CertaraMarch 25, 2025
Protect Confidential Information in Investigational Drug Submissions
March 20, 2025 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…
CertaraMarch 20, 2025
FDA Requirements for Providing Datasets for Nonclinical Studies in SEND Format
March 19, 2025 The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the…
CertaraMarch 19, 2025
Machine Learning for PK/PD Modeling in Drug Development
Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…
CertaraMarch 4, 2025
How the US FDA MIDD paired pilot program helps sponsors
February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…
CertaraFebruary 28, 2025
Scientific Software in Light of the European Accessibility Act
Explore how the European Accessibility Act impacts scientific software, and what life sciences teams must…
CertaraFebruary 26, 2025
Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis
February 24, 2025 Efficient drug development relies on informed decision-making. For toxicologists, having timely access…
CertaraFebruary 24, 2025
The History of Pinnacle 21
February 21, 2025 It was late 2007. Mad Men was the hottest show on TV.…
CertaraFebruary 21, 2025
