As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
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 ...
Pilot studies and feasibility trials form a critical component of the clinical research process by enabling investigators to assess the practicality of study protocols on a smaller scale prior to ...
List of terms commonly used in clinical trial research. Glossary of Medical Terms in Lay Language Helpful list of medical terms described in lay language. Sample Study Startup Checklist Use this ...
A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...
With the rise of biologics, precision medicine and AI-driven drug discovery, clinical research has entered a new and complex ...
Roughly 70 to 80% of ovarian cancer cases are diagnosed at an advanced stage, 1 where treatment options are limited and eligibility criteria for clinical trial participation become more difficult to ...
In 2026, clinical trial teams market uncertainty and identify high-impact areas for AI adoption to remain competitive.
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