Easing the Challenges of Global Feasibility: Strategies to Balance Priorities, Manage Disparate Data Sources and Mitigate Risk

Life Sciences, Clinical Trials, Patient Recruitment & Retention,
  • Tuesday, December 05, 2023

In this informative webinar, explore the challenges of global feasibility and gain insights into strategies for successful study start-ups, including protocol optimization, geostrategy and site selection. Global feasibility is the linchpin of successful study start-ups, but it is not a cut-and-dry process. Successful feasibility goes beyond choosing the right countries and the right sites with proximity to the target patient population. It also requires the careful balance of competing organizational priorities from different stakeholders with the potential risks that each presents.

How do clinical experts find a compromise between stakeholders when evaluating protocol optimization, geostrategy, site selection and delivery performance? In this webinar, global feasibility and clinical operations experts from Regeneron and Parexel will share their insights, best practices and case studies on global feasibility strategies.

The panel of experts will share insights on:

  • The complexity of modeling modern protocols, incorporating assumptions that are meaningful for operational delivery
  • Managing disparate data sources to drive data-rich conclusions about the best strategies, study and country performance and optimal solutions to balance risk and ambition
  • Creating a viable site universe to prepare for future studies, optimize engagement and thereby fast-track site selection
  • Encompassing patient experiences and understanding their standard of care alternatives in understanding the motivation for clinical trial participation
  • Training teams on what data are most relevant to assess future risk

Join this webinar to explore strategies including protocol optimization, geostrategy and site selection to strike a balance between risk and ambition.

Speakers

Amy Froment, Senior Director, Head of Global Trial Optimization, Regeneron

Info coming soon.

Message Presenter
Denis McMillan, Parexel

Denis McMillan, Vice President, Global Feasibility, Parexel

Denis McMillan is responsible for the management and leadership of the Phase II/III solution consultant team and global strategic feasibility group encompassing 50 dedicated staff worldwide.

Denis is an expert in bid management, clinical strategy development and strategic feasibility. He has headed departments of varying sizes for over 15 years and consistently delivered innovation and results while fostering a positive team environment. Denis was specifically brought into ICON and then PPD to change the paradigm in business development and feasibility respectively to deliver expert, value-orientated products. He has rare insight into the challenges of delivering trials at research sites from five years of working in a site management organization.

Message Presenter
Camilla Ramdeen, Parexel

Camilla Ramdeen, PhD, Executive Director, Strategic Feasibility, Parexel

Dr. Camilla Ramdeen has led the global strategic feasibility team at Parexel since 2015 and has 16 years of CRO-based clinical research experience in feasibility and strategy, study start-up leadership, project management, investigator relationships and patient recruitment roles. Prior to joining the industry, she worked as an Oncology Dietitian and Academic Researcher at the Royal Marsden Hospital in London.

Message Presenter

Who Should Attend?

This program will be beneficial for pharmaceutical, medical device and biotechnology professionals working in the following areas:

  • Global feasibility
  • Trial optimization
  • Site identification
  • Site selection
  • Clinical operations
  • Procurement/outsourcing
  • Quality/compliance

What You Will Learn

Attendees will gain insights into:

  • The complexity of modeling modern protocols, incorporating assumptions that are meaningful for operational delivery
  • Managing disparate data sources to drive data-rich conclusions about the best strategies, study and country performance and optimal solutions to balance risk and ambition
  • Creating a viable site universe to prepare for future studies, optimize engagement and thereby fast-track site selection
  • Encompassing patient experiences and understanding their standard of care alternatives in understanding the motivation for clinical trial participation
  • Training teams on what data are most relevant to assess future risk

Xtalks Partner

Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com and follow us on LinkedInTwitter, Facebook and Instagram.

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