Moving Beyond 10 Steps to Clinical Study Startup, Upcoming Webinar Hosted by Xtalks

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In this free webinar, attendees will gain an understanding of the operationalization of ICH E6(R1) and the limitations of only 10 steps in multi-site and multi-country trials. The featured speakers will discuss the benefits of proactive upfront planning in the clinical development plan prior to financially approving the protocol. The presentation will also explore how new techniques and technology can help improve the operational efficiencies of study startup.

Today, study startup functions and job roles are more commonplace at sponsor and CRO organizations, but despite this, clinical operations teams are drowning in data but starving for information at a time of intense pressure to speed up clinical trials and restrain costs.

Until recently, the study startup portion of clinical trials has not benefited from innovation, essentially remaining manual or heavily rooted in Excel spreadsheets, causing this complex process to seriously underperform. The 10 steps to clinical study startup eBook, based on the directives in ICH E6(R1), helped define the site-specific activities at the outset of a clinical trial and to this day remains a very popular download.

Today, study startup functions and job roles are more commonplace at sponsor and CRO organizations, but despite this, clinical operations teams are drowning in data but starving for information at a time of intense pressure to speed up clinical trials and restrain costs.

The average cost of drug R&D is now estimated to be $2.9B by Tufts CSDD — this is unsustainable. Globalization (multi-country studies), the changing regulatory landscape (ICH E6(R2)/(R3), EU 536/2014, etc.), matrix organizational changes and non-traditional trial designs (e.g., decentralized clinical trials) have forced the industry to rethink their approach to study startup. These traditional steps need to be expanded upon, collapsed and fit for purpose. But, how?

Register for this live webinar on Tuesday, November 30, 2021 at 10am EST (3pm GMT/UK) to learn about a modern approach to study startup that addresses today’s drug development challenges.

The webinar will feature the following expert speakers:

  • Gareth Milborrow, SVP of Feasibility, Site ID & Start-Up, ICON; ACRO member company;
  • Lorena Gomez, Senior Director, Global Study Start Up, PRO Management, and Digital Implementation, AbbVie;
  • Andrea Ochoa, VP of Global Study Start Up, Premier Research; CRO Forum member company;
  • Kirill S. Soldatov, Director of Process Improvement, PSI CRO;
  • Tina Karunaratne, Head of Global Clinical Operations, Orum Therapeutics;
  • Jennifer Peterson, Executive Director, SSU & Regulatory, Syneos Health; ACRO member company; and
  • Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences, ACRO member company

For more information, or to register for this event, visit Moving Beyond 10 Steps to Clinical Study Startup.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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