As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
Clinical trials are increasing in complexity at the same time as clinical development teams are being tasked with doing more with less. This panel of experts address why and how protocol complexity ...
The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...
Integrity of clinical evidence matters as AI tools integrate into care, ensuring transparency and trust in medical decision support.
A Swiss startup called Risklick has launched artificial intelligence software for clinical trials that the company claims can reduce development time and costs by as much as 35%, according to an April ...
Most pharmaceutical manufacturers utilize the gold standard of clinical trial design: randomized, controlled trials (RCTs) executed in four phases. Any protocols used must be approved by the FDA under ...
In the first of a two-parter, lawyers at Santarelli analyse the patentability of therapeutic inventions where publication of clinical trial protocols occurs before the application's filing date The ...
High-quality evidence is what we use to guide medical practice. The standard approach to generating this evidence — a series of clinical trials, each investigating one or two interventions in a single ...
The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...