The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...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 future of clinical research depends on people just as much as strong systems and processes. Learn what makes great ...

This page will provide some basic information about clinical trials. For more information about clinical trials in general, please go to www.clinicaltrials.gov. What is a Clinical Trial? A clinical ...

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 ...

Pharmaceutical executives are constantly looking for ways to cut down clinical development costs; listen to any pharma company’s earnings call for proof. And yet there are clinical development costs ...

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.

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The companies behind three major COVID-19 vaccines in development released the protocols of their ...

Industry experts have provided insight into how oncology clinical trials can be designed for success from the outset and rendered as patient-centric as possible. At the Clinical Trials in Oncology ...

The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to ...