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Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Author(s): Alice Ke, Andrzej Kierzek, Angela Colbers, Barry Mangum, Behtash Bahador, David Turner, Ellen Leinfuss, Graham Scott, Iain Gardner, Julie Bullock, Leon Bax, Lora Killian, Maria Saluta, Nathan Teuscher, Nirpal Singh Virdee, Oliver Hatley, Peter Bonate, Rob Connelly, Ronette Gehring, Shriram Pathak, Shuhua Hu, Stacey Tannenbaum, Steve Sibley, Suzanne Minton, Tom Snowden
Solution: Clinical Pharmacology Strategy, Clinical Transparency & Disclosure, Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Scientific Informatics, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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How AI Tech Is Changing Regulatory Writing

Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with […]

Author(s): Nirpal Virdee
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

Author(s): Behtash Bahador, Bernd Wendt, Chris Lovejoy, Christine Yuying Gao, Craig Rayner, Ellen Leinfuss, Karen Rowland Yeo, Lora Killian, Manoranjenni Chetty, Neil Benson, Nirpal Singh Virdee, Patrick Smith, Rik de Greef, Serge Guzy, Steve Sibley, Suzanne Minton, Tatyana Wanderer, Thomas Peyret, Venkateswari Muthukrishnan
Solution: Clinical Trials Simulation, Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Systems Pharmacology
Therapeutic Area: Central Nervous System, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease
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How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. […]

Solution: Clinical Transparency & Disclosure
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