The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
CertaraSeptember 23, 2021
Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
CertaraSeptember 10, 2021
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…
CertaraSeptember 10, 2021
What does the Clinical Pharmacology Plan for a Biologic Look Like?
Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…
CertaraAugust 6, 2021
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
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
Three Pathways have emerged in Innovative Access Agreements
The days of simply determining the market demand for a new drug as a function…
CertaraJune 11, 2021
Outcomes Based Agreements
The days of simply determining the market demand for a new drug as a function…
CertaraJune 11, 2021
De-risk your program with evidence-based secondary pharmacology insights
Safety issues account for about a quarter of the attrition in drug projects and can…
CertaraMay 28, 2021
Stakeholder perspectives: current and potential benefits
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…
CertaraMay 26, 2021
