INSIGHTS ON CLINICAL TRIAL DESIGN

  • Three Key Critical Considerations Before Embarking On Decentralized Trials
    4/11/2020

    Trying to incorporate data collected from new patient-facing technology into a traditional protocol design and operational practices just won’t work. Join Kathy Vandebelt, Global Head of Clinical Innovation at Oracle Health Sciences to learn ways to optimize data flow in hybrid and decentralized trials to improve patient experience, data quality, and expedite the clinical trial process.

  • Factoring The “What Ifs” Into Supply Forecasting
    8/24/2020

    Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.

  • When It Comes To Your Patient Adherence (Compliance) Strategy, Think Training
    7/18/2019

    Sponsors deal with myriad considerations in how to reduce overall risk and costs across a study, but managing the complexity of patient behavior must always stay in focus. The challenge of patient treatment adherence and retention can do a lot more than create delays and increase expenses during a clinical trial. When a patient does not comply with the treatment regimen, the integrity of the clinical trial data is at stake, and patient safety is at risk. Read how a compliance-focused LMS can positively impact patient compliance during a clinical trial.

  • The Case For Patient Diversity In Clinical Trials
    2/25/2021

    Two of America’s greatest assets are its diverse demographics and its relentless pursuit of new medicines and treatments to improve patient lives worldwide. Unfortunately, it’s a widely known (but little discussed) challenge that the two do not go hand in hand. Minority participation in clinical trials is staggeringly deficient.

  • Patient Reported Outcomes And The Common Terminology Criteria For Adverse Events (CTCAE)
    8/5/2019

    The Common Terminology Criteria for Adverse Events (CTCAE) was developed to standardize reporting of adverse events (AEs). Originally developed for oncology trials by the National Cancer Institute (NCI), the CTCAE is now used widely across all types of clinical trials, and as a result has become an essential tool for evaluating trial safety. The CTCAE provides a library of over 800 AEs with guidelines for grading event severity. However, it fails to capture the day to day effects a patient might experience. In order to integrate the patient’s perspective into AE reporting, the NCI developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

CLINICAL TRIAL DESIGN SOLUTIONS

  • Veeva Vault Study Startup accelerates time to site activation by connecting global teams and enabling best practices for managing country and site start-up processes. Document-intensive start-up processes and milestone maintenance activities are managed in a single system, providing unparalleled insight and efficiency. And because Veeva Vault Study Startup works with Veeva Vault eTMF within the Veeva Vault Clinical Suite, study start-up and TMF content and data are seamlessly accessed across teams, systems, and studies.

  • Bringing real-world data to protocol design

    How can IBM Study Advance help clinical development?

    Recruitment challenges and protocol amendments can lead to study delays and failures. These can often be traced back to the protocol design stage.  Poorly conceived protocols can create problems at the study level, the program level and across the full development and commercialization lifecycle.

    IBM Study Advance can help overcome these problems. It’s built to optimize the protocol development process by providing the power of data insights to make informed decisions and a collaboration platform to improve efficiency. IBM Study Advance helps you build study protocols that facilitate an effective and efficient clinical trial.

  • Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data. Our team supports biomarker discovery and diagnostic test development based on biomedical signals and images, and real world evidence analysis.

  • Successful studies begin with the right design. East is the industry standard for designing adequate and well-controlled clinical trials as per FDA and EMA guidance. Since its introduction in 1994, East has reliably and continuously enabled drug and medical device trial sponsors of all sizes to optimize their trial planning and monitoring efforts.

  • Cytel’s dedicated team of professionals is here to help you address an array of challenges when conducting drug development. Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial implementation, Cytel has skilled professionals available when you need them.