05.22.25 -- What's New In Early-Phase Clinical Research?

A timely conversation on how to structure early-phase trials to address population variability and key factors influencing safe drug administration — both critical to developing a comprehensive, equitable drug development plan that reflects diverse patient subtypes.

Incorporating proof-of-concept arms into a Phase I protocol provides earlier access to critical data, supporting more informed go/no-go decisions. This approach can accelerate development, optimize resources, reduce costs, and keep timelines on track.

Did you know that conducting your trials in Canada can accelerate early-phase clinical research by six to nine weeks? Discover the unique advantages of running early-phase studies on novel compounds in Canada versus other regions.

From preclinical models and bioanalytical assays to clinical study design and manufacturing strategies, this issue of The Altascientist features exclusive case studies and expert insights on the complexities of GLP-1 RA development.

Here, we present an overview of the FDA's guidance and key considerations for the clinical development of psychedelics — including assessing abuse potential using the Eight Factor Analysis (8FA), and optimizing trials through effective blinding, active control selection, and the strategic use of facilitators.

In this short documentary, Altasciences leads the conversation on innovation in a traditionally slow-moving industry, examining the challenges of conventional CRO-sponsor relationships and presenting a new, alternative model.

Altasciences provides deep expertise in all clinical pharmacology studies required for successful regulatory submission across a wide range of therapeutic areas.

 

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