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
Pinnacle 21 has evolved and knowledge of its software has become an indispensable skill of every statistical programmer who works with CDISC standards.
RTOR can reduce the approval time for Oncology Clinical Trials without affecting the safety and effectiveness of the treatment.
Regulatory Writing is used to create a variety of clinical documents. Such clinical trial documentation includes clinical study reports. Learn more
Remote monitoring in clinical trials has never been so popular. This article explains a risk-based approach to remote monitoring and remote SDV
Stay up to date with the latest statistics and scientific resources on the novel coronavirus (covid-19) pandemic
Quanticate explores the rise, the issues, and challenges of Adaptive Clinical Trials and the ways to adapt your study, with examples of oncology study design.
Quanticate analyze whether having a Dose Expansion Phase in Phase I Oncology Trials is beneficial and provides information about Efficacy, Safety, Toxicity and Pharmacokinetics prior to jumping into a Phase II Study
Review the use of Multiple Imputation (MI) for handling missing data in clinical trials and ask yourself if it's really worth the effort.
This blog describes the evolution of patient centricity in clinical trials and data collection, and the benefits of working in the biometric industry.