From Past to Future: Using Experience to Enhance Clinical Trial Protocols

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Tuesday, July 09, 2024

This webinar explores the intricate dynamics between sponsors and vendors and how experience allows for adaptation based on past experiences and how best to support change based on new regulatory frameworks and changes to International Conference on Harmonization Good Clinical Practice (ICH GCP).

In this webinar, the speakers will explore the collaborative approach possible and how both sponsors and vendors can leverage lessons learned on past studies to influence future clinical trial protocol implementation to achieve more successful outcomes.

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When the pressure is on to reduce medicinal product wastage, decrease implementation time but not compromise on patient safety and data integrity, experience is key. The expert speakers will share insights on effective communication, risk management and quality assurance within the sponsor–vendor partnership.

The expert speakers will also delve into various facets of the sponsor–vendor relationship, emphasizing the development of trust to foster enhanced collaboration and leveraging vendor expertise to meet project requirements. They will address the influence of regulatory frameworks and offer strategies on adapting to new clinical trial protocols, as well as discuss the importance of protocol optimization by designing strategic endpoints.

Moreover, they will cover risk management and contingency planning by proactively identifying and mitigating risks, as well as the crucial roles of quality assurance and compliance in ensuring regulatory alignment and data integrity. Finally, the importance of effective communication strategies will be highlighted, underscoring their significance in successful project execution.

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Register for this webinar to learn how you can adapt clinical trial protocols to new regulatory frameworks like the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines and optimize protocol implementation to achieve successful outcomes.

Speakers

Peter Craig, Senior RTSM coordinator, Novo Nordisk

Peter Craig is an RTSM coordinator for Novo Nordisk for more than 15 years. He is a veteran of setting up RTSM systems with a variety of vendors, for a multitude of different study designs from phase 1 to 4. He has a wealth of experience in Study set-up, testing, end user training and stakeholder management.

Message Presenter
Siobhan McKenna-Power, 4G Clinical

Siobhan McKenna-Power, Principle Client Services Lead, 4G Clinical

Siobhan McKenna-Power has over 20 years of experience designing and delivering regulated systems, with over 8 years of experience in designing and delivering RTSM systems for clinical trials. She first developed an interest in clinical trials when her father took part in multiple Phase III drug and device trials due to his progressive chronic obstructive pulmonary disease.

She was eager to contribute in her own way when the opportunity presented herself. Siobhan is a strong believer in first-time quality and works with sponsors to understand complex protocols. Siobhan has a keen understanding of what the needs of the end user are and works to ensure that even the most complex trials are easy for Investigators to work with and that patient safety is the foremost priority of any RTSM system.

Siobhan is a Graduate of Maynooth University (formerly National University of Ireland, Maynooth) with a BSc in Computer Science and Software Engineering. She is currently working on a Level 7 Diploma in Risk Management.

Message Presenter

(Moderator) Libbi Rickenbacher, Sr. Director of Product Strategy and Partnerships, 4G Clinical

Libbi Rickenbacher is the Sr. Director of Product Strategy and Partnerships at 4G Clinical. She has over 15 years of experience in the field of life sciences and is an e-clinical Randomisation and Trial Supply Management (RTSM) solutions subject matter expert. Libbi holds a BA in both Neuroscience and Psychology, and a Doctorate (PhD) in Neuroscience.

Message Presenter

Who Should Attend?

This webinar will appeal to:

  • Pharmaceutical companies, biotechs and CROs
  • IRT/IXRS Managers
  • Clinical operations
  • Clinical supply
  • Medication Supply Managers

What You Will Learn

Attendees will learn about:

  • Understanding the sponsor–vendor relationship by developing trust for enhanced collaboration
  • Leveraging vendor expertise by tapping into vendor knowledge to meet requirements
  • Influence of regulatory frameworks and how to adapt to new regulatory requirements
  • Protocol optimization by designing protocols with strategic endpoints
  • Risk management and contingency planning by proactively identifying and mitigating risks
  • Quality assurance and compliance by ensuring regulatory alignment and data integrity
  • Importance of effective communication strategies

Xtalks Partner

4G Clinical

4G Clinical’s suite of innovative RTSM and clinical supply optimization software provides the right-sized support for any phase or trial complexity. At 4G Clinical, all studies are supported by a team of RTSM experts to advise trial teams on the best path forward. Our operations team distinguishes itself through their extensive industry expertise and deep understanding of trial designs and mid-study adjustments. 4G Clinical is committed to helping sponsors and CROs follow the science, wherever it may lead, as quickly and as safely as we can. While we will not discover the next novel compound in the lab, we are doing our part by leveraging our extensive experience and technological innovations to bring speed and agility to clinical trials. As a critical partner throughout clinical development, we can help you seamlessly transition and scale your trials through both protocol and supply complexities to help bring crucial medicines to those who need them, faster. To learn more about how we are tackling the bottlenecks in clinical trials through our innovative solutions, Prancer RTSM® and 4C Supply®, visit us at www.4gclinical.com.

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