As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
In this free webinar, understand the key benefits of master protocols. Attendees will identify the key challenges of master protocols and strategies to address them. The featured speakers will discuss ...
Together, Risklick and Citeline deliver an integrated, intelligent protocol development experience that combines smart ...
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
When we think of a clinical trial we often imagine the global breakthroughs the headlines announcing a new cure or a revolutionary vaccine however the true work happens in the trenches at the clinical ...
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 ...
Dyne Therapeutics has announced a revised protocol for its ACHIEVE trial, elevating video hand opening time (vHOT) to the primary endpoint for U.S. Accelerated Approval of DYNE-101, a treatment for ...
Vielight Neuro RX Gamma device and irradiation configuration used in the randomized, double-blind, sham-controlled trial. The ...
A clinical trial protocol is the foundation of clinical research, detailing objectives, study design, eligibility, safety oversight, and data analysis. Its structure ensures consistency and ...
A controversial hepatitis B vaccine safety trial will go on as planned in Africa, amid concerns over its ethics and design from medical experts. In December 2025 the U.S. Centers for Disease Control ...
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