News

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.

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.

With more common cancers now increasingly broken down by specific genomic defects, the future of research for any cancer is entirely, and unequivocally, molecular.

Outlining the unique pharmacokinetic factors that should be considered when designing and running early stage clinical trials for monoclonal antibodies.

Sobering statistics collected on clinical trial execution point to the eventual convergence of healthcare and clinical research operating environments.

Click the title above to open the Applied Clinical Trials June 2018 issue in an interactive PDF format.

As international outsourcing continues to drive the parties contributing to clinical trials farther apart, technology will increasingly serve as a means of bringing them closer together.

John Reites, THREAD’s Chief Product Officer, will discuss eDROs and the FocalView App in this interview.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

Artificial intelligence is a "new weapon" in healthcare research.

From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.