Newsletter | May 22, 2025

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

 

 

This collection features a range of resources on key topics in early-phase clinical development, reflecting current challenges and considerations in the field.

Assessing Diversity In Early-Phase Clinical Trials In A Rapidly Changing Regulatory Environment

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.

 

Flexibility In Phase 1 Study Timing

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.

 

The Advantages Of Conducting Early-Phase Clinical Research In Canada

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.

 

Managing The Complexities Of Glucagon-Like Peptide-1 Receptor Agonist Drug Development

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.

 

Navigating The Unique Attributes Of Psychedelic Drug 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.

 

Flipping The Drug Development Industry On Its Head

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.

 

SOLUTIONS

Clinical Solutions For Early-Phase Drug Development

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

 

View the complete resource library.

 

Contact an Altasciences expert to learn more about their comprehensive clinical solution.