Clinical Trial Technology Editorial

  1. Janssen’s Lessons Learned From Digital Health Implementation
    6/21/2019

    In his role as product line owner for digital health at Janssen, Mark Sapp leads a team that works directly with different therapeutic areas inside the company. “Our focus is helping our clinical teams get from point A to point B,” says Sapp. “We assist them with taking their idea and scaling it up, identifying the clinical endpoints they hope to achieve, and helping them stay focused on the results they need to generate.”

  2. Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back
    6/20/2019

    Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.

  3. Lessons Learned From An RBM Implementation
    6/13/2019

    In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience.

  4. Leveraging AI To Assess Clinical Trial Technologies
    6/13/2019

    As part of our ongoing series detailing an approach for the rapid assessment and prototyping of digital and other clinical trial technologies, we introduce here the use of artificial intelligence (AI) and machine learning (ML) to optimize clinical study design and execution. 

  5. The Challenges And Opportunities Of RBM Implementation
    6/11/2019

    In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience.

  6. A Platform Approach Simplifies Clinical Workflow For Idorsia Pharma
    6/6/2019

    Idorsia Pharmaceuticals Ltd was founded in June 2017 and came about as a result of the acquisition of Actelion Pharmaceuticals by Johnson & Johnson. Transition agreements allowed the company to use legacy systems from the prior company for a period of 18 months. By the time the agreements expired, Idorsia would have to design its own systems landscape.

  7. What Is Taking So Long For Meaningful Interoperability In Clinical Research?
    6/6/2019

    Three decades ago when I entered the profession of clinical research, our workplace equipment extended to typewriters, white-out, mimeographs, hand-written documents, rubber erasers, pens, label makers, and fax and copy machines. Rows of massive, locked, fire-proof filing cabinets storing millions of papers for a nationally funded research program lined record rooms, hallways, and every spare corner of the offices. Most of us felt rewarded when we could use a typewriter with a correction key despite one’s typing skills being firmly judged by the illegible mistakes in the carbon copies.

  8. Humans And Machines Will Partner For Better Outcomes
    6/3/2019

    Dr. Emmanuel Fombu spends a lot of time thinking about healthcare. He’s a trained physician and currently leads global strategy and digital innovation at Johnson & Johnson. He would like to see better roadmaps in healthcare that lead us to determining a patient’s level of health. Currently, your doctor asks a question, you supply an answer, and this begins the process of trying to figure out what might be wrong with you.  

  9. AI And Blockchain Will Take Center Stage At DIA 2019
    5/30/2019

    A Q&A with Sudip Parikh, PhD, senior VP and managing director, DIA Americas

  10. Talking The Talk: How AI-Informed Virtual Assistants Are Changing Clinical Development
    5/23/2019

    The pharmaceutical industry as we know it today has roots that reach back to the apothecaries and pharmacies of the Middle Ages, when drug discovery largely involved sourcing plants and herbs for natural remedies and drug development and testing was an unstructured concept that relied on the hit-or-miss reactions patients experienced.1 Failure was arguably more common than success and, unfortunately for the patients, treatment courses often did not yield optimal results.