Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data Press Release Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton,…CertaraAugust 5, 2021
Succeeding in Value Communication: Introduction Blog Succeeding in Value Communication: Introduction Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…CertaraAugust 5, 2021
Takeover of lifecycle maintenance of investigational new drug applications Case Study Takeover of lifecycle maintenance of investigational new drug applications A Tier 3 Sponsor with active clinical investigations and multiple active, existing Investigational New Drug Applications (INDs) was unhappy with their current vendor’s support. The Sponsor selected Certara as its new vendor for…CertaraAugust 2, 2021
Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines Publication Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines Optimal use and distribution of coronavirus disease 2019 (COVID-19) vaccines involves adjustments of dosing. Due…CertaraJuly 31, 2021
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study In this case study, the sponsor’s closing of a manufacturing site required that one of…CertaraJuly 29, 2021
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…CertaraJuly 29, 2021
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking On-Demand Webinar PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics,…CertaraJuly 26, 2021
What is BaseCase? Video What is BaseCase? Developing interactive and easy-to-use stakeholder engagement content market access, medical affairs, and sales field teams…CertaraJuly 20, 2021
Strategic Planning and technology to support a rolling BLA submission under tight timelines Case Study Strategic Planning and technology to support a rolling BLA submission under tight timelines A Tier 3 Sponsor called upon Certara to support its rolling BLA submission, the second…CertaraJuly 19, 2021
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate On-Demand Webinar Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…CertaraJuly 15, 2021