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In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority Voucher (CNPV) Program is accelerating operational timelines, tightening cross-functional workflows, and redefining what sponsors and CROs must deliver to secure and execute an ultra-compressed one-to-two-month review.

In today’s ACT Brief, we examine how the CRA role is transforming alongside modern clinical trial technology, review the FDA’s approval of Imfinzi plus FLOT as the first immunotherapy regimen for resectable gastric and GEJ cancers, and look at Novo Nordisk’s fast-tracked submission of its higher-dose Wegovy injectable under the Commissioner’s Priority Review Program.

The company submitted the new dosage for approval based on its Phase III trial results.

The approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

As clinical trials become more complex and decentralized, the role of the CRA is evolving from site monitor to strategic, digitally fluent partner, requiring expertise in hybrid oversight, risk-based monitoring, and multi-system data management.

In today’s ACT Brief, we examine how AI is being integrated into administrative workflows at investigative sites, highlight the FDA’s approval of the first gene therapy for adolescents and adults with SMA, and explore strategies for pharmaceutical companies to build high-performing hospital-based clinical trial programs.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

As AI adoption accelerates across clinical research, clear distinctions between AI agents, AI teammates, and integrated intelligence are essential for understanding how automation will reshape site operations, workforce roles, and end-to-end study processes.

In today’s ACT Brief, we examine how AI and functional service partners are reshaping global pharmacovigilance, look at new data on how investigative sites are investing in and integrating digital solutions, and explore how Trialbee assesses ROI across emerging multi-touch recruitment platforms.

A new global Tufts CSDD survey of 387 investigative site professionals reveals broad experience with digital and decentralized trial tools, growing site-driven technology investments, and strong support for remote data collection—while highlighting persistent burdens tied to fragmented systems, training demands, and financial strain.

How pharma–hospital partnerships can overcome operational, financial, and organizational barriers to build high-performing clinical trial programs that expand access, accelerate accrual, and strengthen research capacity across both academic and community settings.

Explore methods to evaluate recruitment performance across multiple platforms, including engagement tracking, conversion analysis, and data-driven optimization for emerging digital spaces.

New 48-week results from the Phase IIIb APEX trial show Tremfya delivers sustained radiographic protection and deeper clinical responses in active psoriatic arthritis, reinforcing its potential as an early, structural-sparing therapy.