Pinnacle 21 Data Exchange: Transforming External Vendor Data Management
The volume and complexity of clinical data are growing at a faster pace than the…
Certara2022 年 9 月 19 日
Navigating the Biotech Funding Crunch: How to Achieve Your Next Value Inflection
For the past two years, the biotech sector saw a surge of venture funding and…
Certara2022 年 8 月 30 日
Using Clinical Pharmacology & Pharmacometrics to Accelerate Cell Therapy Development: A Patient’s CAR-T Journey
Cell therapies aim to treat, prevent, or potentially cure diseases. They are a relatively new…
Certara2022 年 7 月 8 日
eCTD Submission Challenges
Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges.…
Certara2022 年 6 月 1 日
Learn how to shorten the drug discovery design-make-test-analyze cycle with D360
Researchers use D360 to query research data efficiently across different data sources and to create…
Certara2022 年 5 月 25 日
Ask Me Anything: Career Opportunities in Regulatory & Medical Writing
Have you ever wondered what it would be like to be a Regulatory or Medical…
Certara2022 年 5 月 12 日
Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator
Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical…
Certara2022 年 5 月 9 日
Smarter Clinical Document Automation for Transparency and Disclosure Requirements
Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive…
Certara2022 年 4 月 14 日
eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus
Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…
Certara2022 年 3 月 22 日
Improved Workflow and Expanded functionality of RsNLME v1.1
R Speaks NLME (RsNLME) is a collection of R packages and companion RShiny apps that…
Certara2022 年 1 月 31 日
