Catalyzing DMTA Information into Insights Blog Post
Drug discovery is a data-driven research process that requires accurate data capture, ample and reliable data storage, and real-time data analysis. Timely access to all compound data is essential for…
Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model? Blog Post
Jeffrey Abolafia June 27, 2024 Advances in technology and changes to the regulatory environment have resulted in a change in drug applications, from being comprised of a collection of randomized...
Generative AI Tools for Regulatory Writing Blog Post
Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand scientific concepts and the latest regulations and guidelines to produce compliant regulatory documents. As a...
RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind Blog Post
EMA Policy 0070 is a main driver for clinical trial data anonymization. This regulation requires publishing clinical data in regulatory submissions of investigational drugs. This policy aims to increase the…
ICH M12 Guidelines & Your Drug-Drug Interaction Package Blog Post
We have provided an overview of the key changes to the ICH M12 drug-drug interaction guideline and a summary table for quick reference.
Case Study. Enhancing HEOR Global Knowledge Sharing Blog Post
The Global Health Economics and Outcomes Research (HEOR) team of a leading global healthcare company in the pharmaceutical industry was facing significant challenges in distributing extensive training materials across various...Celebrating Certara’s 10th Annual Kraków HTA Symposium Page
Celebrating Certara’s 10th Annual Kraków HTA Symposium With over 100 attendees, the 10th Annual HTA Symposium, held in Kraków May 20-21, brought together a diverse group of stakeholders, including representatives...
How a top 10 pharma fought the rising tide of non-CRF data Blog Post
Discover how a top pharma company used Pinnacle 21 Data Exchange to automate non-CRF data management, cut resource use by 80%, and speed up submission timelines.
