Clinical Leader Webinar

  1. eSource Data Capture Simplified — Uncover Time and Cost Saving Possibilities

    This webinar will discuss some of the benefits of an eSource approach, which include eliminating double entry of data and the need for source data verification, reducing the need for data queries, and optimizing monitoring time. 

  2. Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

    Presenting the FDA with a coherent and clear integration of the data from your product development program is imperative and requires a sound strategy and a skillful approach.

  3. Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

     In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency’s guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection.

  4. Trial Master File (TMF) Reference Model

    In this webinar, Kristen Snipes, Project Director and Missy Lavinder, Senior Project Manager share tips and tricks for making the process manageable based on their own recent experience implementing the model.

  5. Leverage Your EDC Solution to Mitigate Risk in Clinical Research

    Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals.

  6. New FDA Guidance On Regulatory Submissions in Electronic Format

    In December 2014, FDA released the finalized Guidance for Industry “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” In this webinar, Rob Woolson and Ben Vaughn will review key points in the guidance followed by a discussion of the implications for Sponsors currently conducting studies as well as those who will be starting new studies soon.

  7. Advancing Research In Skin Biology with Metabolomics

    This 30-minute webinar demonstrates how metabolomics can be a powerful tool in dermatological and skincare research.

  8. Leveraging Metabolite Biomarkers For Clinical Trials

    This 30-minute webinar will introduce a robust, highly sensitive biomarker development program that leverages a revolutionary metabolomics discovery platform to improve the range of analytes that can be measured routinely and reliably.

  9. Tapping The Metabolome For Answers- A State Of The Art Approach

    This 30-minute webinar provides a brief overview of recent advances in metabolomics technology and methodology, which together have advanced the field of metabolomics.

  10. Strategic Considerations For Implementing A Regulatory Document Management System

    Regulatory content across a product lifecycle is abundant, cumbersome, and absolutely critical to both the product and organization's success.  It ensures both corporate and agency compliance and proves accountability.