03.26.26 -- Engage Early With The FDA On AI … Or Expect Problems

You've heard it before; sponsors must engage FDA early when using AI in clinical development. Hilary Marston warns that late engagement can cause irreparable damage to your regulatory strategy.

The FDA’s CSA framework replaces traditional CSV with a risk-based approach, reducing inefficiencies and enabling faster innovation. Learn why this shift matters for your organization.

The initial IRB submission process can involve common challenges. To help you overcome these obstacles, discover seven fundamentals you should know about a successful initial IRB submission.

Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.

The long-awaited ICH E6(R3) guideline is here and will reshape clinical trial standards. Get ahead of the transition with a detailed comparison and strategic insights designed for sponsors and CROs.

Many U.S. oncology sponsors are expanding their late-phase trials into Asia to secure access to rich patient pools, leverage efficient regulatory pathways, and save time and money in the clinic.

Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.

Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.

By improving convenience, ensuring precise dosing, and reducing dependency on healthcare facilities, autoinjectors enhance patient outcomes and quality of life.

 Learn practical steps to make smarter vendor decisions, including how you can simplify CRO selection, improve transparency, and ensure the right operational fit.

Uncover how we're able to bring integrated services and trusted scientific insight to every program.

Despite its challenges, advancements in screening and new therapies offer hope for better outcomes.