Insights On Clinical Technologies

  1. Learnings On Bring Your Own Device Uptake For eCOA Implementation

    In this poster, we cover research designed to understand site and subject behavior towards the use of “bring-your-own-device” (BYOD) and provisioned handsets, including usage and access behavior, with reference to two large clinical trials.

  2. What Makes A Good Data Manager?

    In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved.

  3. 10 Things We’ve Learned In 10 Years Of E-Clinical Innovation: Part 1

    Trial Interactive turns 10 this year and we could not be more proud—from an early eTMFinnovator to an end-to-end e-clinical platform, we’ve grown tremendously. Part of that growth was in realizing early that effective e-clinical innovation is powered by partnership and collaboration, which has been possible with 25+ years’ experience in the life sciences industry and 10 years of experience in e-clinical innovation.

  4. In The Midst Of This: The Data Management Perspective On The Interim Analysis

    Patti Arsenault, Cytel's Global Head of Data Management, shares her thoughts on the three core elements important for the success from the data management standpoint - effective timeline management, thoughtful database design, and a proactive approach to data cleaning.

  5. Central Laboratory Interlaboratory Comparison Program To Assess The Comparability Of Data Of Tests From Four Regional Laboratories Involved In Global Clinical Trials

    The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.

  6. Critical Operational Considerations For Interim Analyses

    Highlights from Adam Hamm, Director Biostatistics at Cytel, presentation on best practices and operational considerations for adaptive designs and interim analyses.

  7. Addressing The Problem Of Feature Selection Using Genetic Algorithms

    In the new era of big and complex data, conventional methods of solving search problems are sometimes ineffective.Genetic algorithms provide a highly effective solution to many such problems, and therefore their popularity and adoption are on the rise.

  8. 5 Reasons To Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy

    An important trend in clinical development involves integrating strategic pharmacometric analysis with program-level decision making to make the most use of available data. This article highlights five reasons why you should consider utilizing model-based meta-analyses (MBMAs) for your program or portfolio development.

  9. Non-Compartmental Analysis And The Early Phase Regulatory Environment

    NCAs are an integral part of establishing an early phase audit trail, it is important to use NCA software that streamlines a detailed and complex workflow.

  10. Novel immunotherapies Lean On Old Methods For Statistical Challenges

    Many drugs in the IO arena do not follow well understood traditions so the standard statistical approaches to evaluating safety and efficacy may not always be optimal or efficient. As it turns out, as is often the case with methodological research, that alternative methods are available, have been for a long time.