A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
This guide demonstrates how to plan, review, produce successful integrated summaries of safety and effectiveness (ISS & ISE) for regulatory submissions
This blog post reviews the Advantages of Parallel Processing on the reporting and analysis of clinical trial data using SAS/Connect. Learn more with Quanticate's programming experts.
This blog post reviews re-randomization tests in equivalence trials and superiority trials and if, when and how to use them.
This blog post reviews the FDA's guidance for Human Gene Therapy (GT) for Hemophilia A & B clinical trials and what is needed to support an accelerated approval approach. Learn More
This infographic presents survey data that indicates the increase in the use of risk-based monitoring and how data from trials using RBM solutions has risen
This Quanticate blog post examines the rise of Risk Based Monitoring in clinical trials and growing trends from industry data in the adoption of RBM
Quanticate blogs on the different phases of clinical trials that are classified into 4 phases, with each potentially lasting for several years.