News

Praxis Precision Medicines’ Essential3 program met all primary and key secondary endpoints, with ulixacaltamide showing significant improvements in tremor control and daily functioning in patients with essential tremor.

As pharma wrestles with whether to trust fully autonomous AI, semi-autonomous agents are emerging as a safer middle ground that reduces manual work, eliminates white space in clinical development, and accelerates trial timelines without compromising patient safety.

The quest to turn patient retention from a chronic challenge into a competitive strength—and one that benefits all stakeholders.

Understand how intelligent study design, focused data collection, and faster analytics can help clinical teams deliver meaningful results that sustain investor momentum.

Eli Lilly’s oral GLP-1 therapy, orforglipron, met all primary and key secondary endpoints in the Phase III ACHIEVE-2 and ACHIEVE-5 studies, showing significant A1C reduction, weight loss, and cardiovascular benefits compared to both dapagliflozin and placebo.

With global supply chains inherently vulnerable to trade policy shifts, the consequences for clinical research can be significant without proactive planning. The eight core elements of a tariff contingency plan are outlined.

Gain insight into why early toxicology readiness and strong scientific collaboration with CRO partners are critical to accelerating trial startup and regulatory approval.

How a strategic approach to the pre-investigational and investigational new drug application process can be used as a business and clinical catalyst.

Uncover how improving data accuracy and leveraging synthetic control arms can optimize trial efficiency, reduce costs, and generate stronger real-world insights.

Although DEI remains a core tenet in pharma, strategies and goals have been reframed to align with the evolving political climate.

To maximize the impact of signal detection, KRI frameworks should follow a few guiding principles.

Examine strategies for validating, monitoring, and safely deploying configurable AI agents to ensure compliance and performance in clinical trials.

Capturing insights from clinical research professionals on the key trends and challenges shaping drug development today, from those in clinical trial operations and site relationships, to technology and AI, and the evolving regulatory and policy terrain.

An analysis of primary Phase II protocols paired with their Phase III pivotal trials spotlights the need to balance scientific curiosity with participant and site burden.

Why discussions with patients should go deeper than data-centered dialogues—and emphasize trust, personal connections, and community engagement to foster informed choices in public health.

Last week’s top stories explored how NIH’s shutdown plan is testing research resilience, why data infrastructure must precede AI adoption in 2025, and how sponsors are redefining outsourcing with hybrid resourcing models focused on flexibility, quality, and collaboration.

Ways to identify false certainty, or "errogance," during the clinical site start-up-to-launch process—and better ensure site readiness and prevention of costly errors.

Take a closer look at how agentic AI can automate repetitive monitoring tasks while keeping human oversight central to critical decision-making in clinical research.

Regulatory inspections of interactive response technology systems have surged 140% since 2022, signaling intensified global scrutiny of data integrity, randomization, and system validation in clinical trials.

In this episode of the ACT Podcast, we highlight a recent Q&A featuring Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk; and a feature article by Chris Driver, senior director of product management, Patient Suite at IQVIA, in which they both highlight how sponsors are adopting automation to streamline operations.

Gain perspective on how agentic AI can bridge eCOA, EDC, IRT, and CTMS platforms to reduce manual effort and improve operational efficiency.

Understand how adaptive human-in-the-loop frameworks can maintain safety and decision quality as AI becomes more embedded in trial monitoring and data review.

Learn how streamlined confidentiality agreements and consistent workflows can speed site activation and improve sponsor-site transparency.

Gain insight into how listening to site feedback and prioritizing engagement, training, and local patient understanding can drive smoother startups and stronger study outcomes.

The convergence of AI, decentralized technologies, behavioral science, and real-world evidence opens the door to a new era in which the clinical trial industry proactively addresses participation barriers, integrates social determinants of health, and reimagines patient centricity.

Gain insight into how AI-powered agents can eliminate inefficiencies, shorten development timelines, and free clinical teams to focus on strategic decision-making.

Explore ways to reduce redundancy in site training by applying adult learning principles and focusing on enrollment and randomization essentials.

The latest federal shutdown leaves the NIH operating with just one-quarter of its staff to maintain patient care at its Clinical Center, while broader funding cuts and proposed agency consolidations threaten the future stability of US biomedical research.