As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...
Together, Risklick and Citeline deliver an integrated, intelligent protocol development experience that combines smart ...
Vielight Neuro RX Gamma device and irradiation configuration used in the randomized, double-blind, sham-controlled trial. The ...
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 ...
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.
Clinical trials continue to be a driving force in ophthalmology, propelling the development of innovative treatments and ...
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
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 ...
HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in ...
HIGHLIGHTSFollowing an interim data review of the Cohort Expansion Phase (Phase II) of the SECuRE trial, the Safety Review ...