White Papers

  1. MHRA’s GCP Findings: It’s About Oversight
    9/25/2018

    Hone in on the critical findings around the TMF and recording/keeping of essential documents.

  2. A Build Vs. Buy Look At Study Activation
    9/12/2018

    How  a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.

  3. Getting to True Agile IRT: 5 Questions To Ask Your IRT Vendor
    9/4/2018

    While many vendors are claiming agile IRT capabilities, it is important to dig deeply and examine these claims – as well as a company’s proven ability to provide predictable, consistent delivery of project timelines and quality.

  4. Making eSource Work: Beyond The Hype
    9/4/2018

    Implementing eSource can mean operating differently from the norm, with potentially an initial layer of complexity before things become simpler.

  5. A Survival Guide To Temperature Data In Life Sciences
    8/22/2018

    Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.

  6. Gene Expression For Keeping Pace With Immuno-Oncology Breakthroughs And Biomarker Identification
    8/9/2018

    A summary of the clinical relevance of RNA-Seq as well as when and how to use gene expression profiling for biomarker discovery for immunotherapy trials.

  7. On A Technology–Enabled Collision Course: Clinical Research And Clinical Practice Converge Through Real World Evidence
    8/6/2018

    Late Phase Research in the Life Sciences segment is undergoing a rapid transformation due to the digitalisation of healthcare and the greater availability of, and access to, Real World Data (RWD). This transformation is arriving not a moment too soon, given the changes anticipated from the Twenty-first Century Cures Act, EMA’s Adaptive Pathways approach, and the increased demand for Real World Evidence (RWE) generated from these RWD. In addition to supporting regulatory decisions, RWE is playing an ever expanding role in developing the product value propositions that are driving reimbursement decisions globally.

  8. New Opportunities For Immuno-oncology Clinical Development Programs Through T Cell/B Cell Repertoire Profiling
    7/26/2018

    Immune repertoire profiling provides better outcomes for immuno-oncology development programs .

  9. Analytics And Metrics Help Pinpoint Costs Of Study Startup
    7/20/2018

    Learn how by embracing a systematic, data-driven approach, it is possible for metrics to identify more accurately the best sites, steps causing delays, the associated costs, and why this is happening.

  10. More Collaboration With Investigative Sites: Less Technology Overload Delivers Transparency And Efficiencies
    7/20/2018

    Learn about how sites struggling under the weight of too much technology, yet looking for a more robust collaboration and transparency process can benefit from automated workflows in the initiation of clinical trials.