• FDA Issues Draft Guidance On Reporting Real-World Evidence Use

    Clinical Research News Brief | Last week, FDA released a draft guidance on submitting documents using real-world data and real-world evidence to FDA for drugs and biologics.

    May 17, 2019

  • Duke's Big-Bang CTMS Deployment For Clinical Research

    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.

    May 16, 2019

  • The Digital Trial: How Technology Is Changing Trial Design, Start-Up And Close-Out

    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.

    May 15, 2019

  • Use Case Factory And 'Interoperability Land' For Data Sharing At Scale

    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."

    May 14, 2019

  • Getting Real With AI

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

    May 13, 2019

  • Industry Representatives Release Call-To-Action On Patient Insight Compensation

    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.

    May 7, 2019

  • Applying Machine Learning To Everyday Medicine

    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.

    May 7, 2019