Insights On Trial Design

  1. A Build Vs. Buy Look At Study Activation

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

  2. Message To ClinOps Leaders: The Organizational Planning Textbook Wasn’t Written For This!

    Five considerations to help organizations make better planning and forecasting decisions in an environment with such strict parameters.

  3. Solution Provider Submits Periodic Adverse Drug Experience Reports (PADERs) For A Multinational Specialty Pharmaceutical Company

    Submission of PADERs to the FDA is required during post-marketing drug safety surveillance. Instill confidence in your results and regulatory submissions by partnering with an experienced partner.

  4. Pharmacovigilance As-A-Service (PVaaS) Provides Key End-To-End Support To Meet Pharmacovigilance Needs For A Specialty Pharmaceutical Company

    PV activities will continue to grow in volume and complexity. Trusting an experienced partner to help manage PV requirements can free your team to concentrate on patient efficacy outcomes.

  5. Clinical Services Company Eliminates Drug Supply Waste

    How the use of tools can enable your objective of ensuring patient safety by having the right amount of material available with an appropriate investment in inventory cost.

  6. The Treacherous Study Startup Journey

    With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start.

  7. Disassembling Endemic Silos In Pharma Pivotal To Improving The Clinical Trial Continuum

    Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.

  8. Proactive Planning Is Key To Process And Quality Improvements In Clinical Trials

    How to employ processes that take an upfront approach to preventing or mitigating problems associated with document completion.

  9. Gene Expression For Keeping Pace With Immuno-Oncology Breakthroughs And Biomarker Identification

    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.

  10. Pediatric Clinical Trials: The Need for Regulation

    An overview of the progress that has been made in pediatric drug development.