Insights On Clinical Technologies

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Custom Software Enhances Decision-Making

    AstraZeneca needed a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features.

  8. Solution For Independent Data Monitoring Committee Services

    Client turns to this CRO when they needed a team experienced with the full range of IDMC activities to provide a seamless solution.

  9. The Role Of The CRO In Effective Risk-Based Monitoring

    A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.

  10. The TMF Summit In Amsterdam: Integration, Inspection Readiness, And Avoidable Inspection Findings

    Once again, this year’s TMF Summit was an excellent opportunity to exchange thoughts and learn about the latest trends and practices around TMF management.