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.
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.
This 30-minute webinar demonstrates how metabolomics can be a powerful tool in dermatological and skincare research.
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.
This 30-minute webinar provides a brief overview of recent advances in metabolomics technology and methodology, which together have advanced the field of metabolomics.
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.
Adaptive trial design is critical in all phases of oncology drug development and helps overcome many hurdles of traditional study design. In a recent webinar, PPD’s Dirk Reitsma, M.D., vice president, global product development, and Niklas Morton, vice president, global biostatistics, programming and medical writing, analyzed the incorporation of adaptive trial design in oncology trials. They were joined by Scott Berry, Ph.D., president and senior statistical scientist with Berry Consultants, to assess the early decision making benefits that are critical to the decreasing drug development time and providing increased benefit to patients.
Will BRIC be the Savior for the Life Sciences and Medical Devices Sector? Discover key lessons from the field and best practices vital to reap rewards from these countries during Frost & Sullivan’s complimentary webinar. The briefing will benefit any senior manager in the corporate strategy or global marketing areas that focuses on emerging markets, as well as any healthcare company looking to explore BRIC countries.
Get your trials up and running faster and your products to market more quickly. Learn how Startup InSite™ technology and the CFS Clinical Contract and Regulatory Services team speeds up the process.
In this webinar, experts will discuss the benefits of using mHealth technology in clinical trials and take a deep dive into the data quality and regulatory considerations that must be evaluated when choosing a medical vs. consumer-grade sensor.
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