Clinical Research News Brief | Last week, FDA released a draft guidance on submitting documents using real-world data and real-world evidence to FDA for drugs and biologics.

Clinical Research News | Last May, Duke went live with a new set of information systems designed to create a standardized clinical research experience for all biomedical researchers across the life cycle of their studies. All told, the migration took well over two years to stage.

Clinical Research News Contributed Commentary | Digital Health is emerging as a solution to poor trial design. By incorporating technologies such as AI, big data, wearables, sensors, and smartphone apps, Digital Health has the potential to improve trial design from start-up to close-out, increase R&D productivity, and provide the data that sponsors need for better decision-making.

Clinical Research News | A nonprofit public-private collaboration has developed a successful and repeatable methodology to "mass produce data sharing by figuring out what not to do."

Clinical Research News | Thinking about artificial intelligence (AI) has changed dramatically over time and has become about as hard to describe as art.

• Novartis, IQVIA, Syneos Health, UK Office for Life Sciences, NIHR, Deloitte and more keynote speakers to share unique insights 
• Conference breakouts offer attendees interactive, hands-on learning opportunities to design, conduct, manage, and monitor the next generation of clinical research studies

Clinical Research News | A group of pharmaceutical representatives, patient advocates, and researchers—including AstraZeneca, HealthiVibe, Janssen, and others—have released a call-to-action, advancing the conversation around fair compensation for patient insight.

Clinical Research News | Clinicians have largely overcome initial fears and doubts about the use of artificial intelligence (AI), and are now wanting to know what real-world clinical problems it can solve and how to trust it.