Expert Insights On Data Management & Analysis

  1. 9 Ways Unified Clinical Data Cloud Platforms Solve Data Challenges In Rare Disease 2/8/2024

    A unified clinical data cloud platform is a data and analytics platform that contains a data hub to aggregate clinical data from multiple data sources and in multiple formats — and it could be the cure for disordered rare disease data.

  2. Digitizing The Clinical Protocol: Small Steps For Seismic Change 1/30/2024

    A proliferation of clinical trial platform systems has meant increased friction for data exchange. Discover how TransCelerate is tackling this problem with small steps that yield big results.

  3. Objectively Evaluating Innovative Therapies And Making Sense Of Emerging Data 1/22/2024

    Poseida Therapeutics' President and CEO, Kristin Yarema, Ph.D., details why allogenic CAR-T compares favorably with autologous CAR-T, and why, in many ways, allo has advantages that auto cannot hope to match.

  4. AI In Drug Discovery And Development — Will It Live Up To The Hype? 1/5/2024

    While AI may soon transform the drug discovery and development process, there are still several barriers, both technical and ethical, to the rise of AI in biopharma.

  5. What Clinical Trial Experts Think Will Happen With AI In 2024 12/26/2023

    In part one of this preview of clinical trials trends for 2024, experts discuss the applications of AI in clinical research.

  6. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

  7. Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement 12/12/2023

    The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.

  8. Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply 11/30/2023

    While it is challenging to make precise predictions for clinical trial supplies, applying Bayesian statistics will help. This article shares steps to plan your Bayesian approach and how it helps to reduce waste and prevent shortages.

  9. 5 Habits For Ship-Shape Source Data 11/28/2023

    ALCOA+ — or Attributable, Legible, Contemporaneous, Original, and Accurate + Complete, Consistent, Enduring, and Available — is the basis for these must-follow tips from Moderna Senior Manager of R&D Quality Kaitlin Bova.

  10. An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development 10/30/2023

    The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.