News

In this article, we will discuss trends and challenges with medical monitoring clinical analytics, analyze the alignment of existing medical monitoring tools and technologies with ICH-E6 (R2) addendum guidelines, and discuss trends in medical monitoring insourcing and outsourcing models.

To manage the growing scope and complexity of global disclosure regulations and trial transparency initiatives, companies are advised to create a cross-functional clinical transparency committee.

Companies can utilize the following five tools to set themselves up for a successful trial.

The Office for Human Research Protections at the US Department of Health and Human Services and the US Food and Drug Administration issued a final guidance on May 17 on Institutional Review Board written procedures, which are required under both OHRP and FDA regulations.

During an audit, the FDA investigates six areas to determine whether a site is in compliance with federal drug accountability regulations-can sponsors answer them?

A look at home and dosing site considerations.

Editor-in-Chief Lisa Henderson speak about therapeutic needs, rare diseases in children, and the SCORR Marketing survey on innovative or flexible trial designs.

Findings from a new ACT and SCORR Marketing survey reveal the most actively used flexible design approaches in clinical research-many with application in rare disease.