Poorly managed temperature excursions can be detrimental to the success of a clinical trial. In the supply-chain, managing the process for temperature-sensitive products is extremely intricate and time-consuming.
This webinar will cover, in case study format, Grünenthal’s implementation of a new automated receipt process within Suvoda’s interactive response technology (IRT) system.
Learn about the challenges Grünenthal faced when trying to automate the temperature-controlled shipment receipt process. To automate this process, an integration across three systems was needed, which required close collaboration from Suvoda, Catalent, and Berlinger Group. Learn about the approach that Grünenthal and Suvoda took when first implementing this process within the IRT system and how the results of this pilot clinical trial compared studies not using an automated process.
This webinar will be important for sponsors using temperature-sensitive products because they will learn:
- The intricacies of an automated receipt process within the supply chain lifecycle
- How to overcome challenges faced in a multi-system integration
- How Suvoda’s IRT system turned Grünenthal’s 29-day excursion data evaluation into a same day automated process
- Why this process will have an impact on the future of drug development
Speakers
Kelly Snow, Vice President, Product Management & Marketing, Suvoda
Kelly Snow has spent her career in professional services and product development teams working with Top 10 Pharma companies in e-clinical focused organizations, including Phase Forward and Oracle as well as B2C technology companies. As Vice President of Product Management & Marketing at Suvoda, she’s responsible for the strategic direction of the Suvoda product suite. Kelly holds a bachelor’s degree in Interdisciplinary Studies in Bioethics focusing on Neuroscience and Philosophy, a certificate in Conceptual Foundations of Medicine, and a minor in Italian Literature and Language from the University of Pittsburgh.
Message Presenter
Libbi Rickenbacher, Project Manager, Suvoda
Message Presenter
Henk Dieteren, Associate Director, Senior Clinical Supply Manager, Grunenthal
Henk Dieteren has worked in clinical trial supply since 2010. As Senior Clinical Supply Manager, Associate Director, he is primarily responsible for the support, counsel and supervision of Grunenthal’s Clinical Supply Managers in the set-up of trial specific clinical supply concepts ensuring GMP, GDP and GCP compliance. In addition, he focuses on continuous improvement of Grunenthal´s logistical processes in clinical trial supplies. Henk commenced his work in clinical trials in 1994 for Dutch company Tramedico B.V., and switched to his current employer, Grunenthal GmbH, in 2005. Since 2010, he has been working towards continuous enhancement of IRT to improve management of clinical supplies, particularly in controlled drug trials. His current challenge in clinical supply concepts is the set-up of an automated process for clinical trial supplies requiring temperature-monitored shipments and storage, in order to limit the impact on trial subjects´ safety by missing temperature data.
Message Presenter
Raphael Bartsch, SmartView Product Owner, Berlinger & Co. AG
Raphael Bartsch has spent the last 13 years in various product management positions in B2B technology companies. He was responsible for measuring instruments, firmware and cloud solutions in companies like Testo and Bosch. At Berlinger, he is the responsible Product Owner of the SmartView data management cloud solution, identifying market needs and defining strategy directions. He is a graduate engineer and convinced agilist. He holds multiple certificates in Scrum Product Ownership and Scrum Mastery.
Message Presenter
Shailesh Patel, Global Director Technology Strategy, Catalent
Shailesh Patel is Global Director Technology Strategy, Customer Integration within Catalent’s Clinical Supply Services (CSS) business unit. He has a BSc(HONS) degree in Information Technology from DeMontfort University in Leicester, UK. Shailesh has been an IT professional for 28 years, of which the last 14 have been specifically in Clinical Supply Services. He is a member of the ISPE EU IP steering committee as well as being part of the CSS senior leadership team.
Message PresenterWho Should Attend?
Professionals from pharmaceutical, biotechnology, and CRO companies who are utilizing temperature-sensitive products or interested in this type of trial design.
Relevant job titles include Managers/Directors/Vice Presidents involved in:
- Clinical Operations
- Clinical Supply Management
- Study Management
- Procurement/Outsourcing
- IRT (Interactive Response Technology)
What You Will Learn
- The intricacies of an automated receipt process within the supply chain lifecycle
- How to overcome challenges faced in a multi-system integration
- How Suvoda’s IRT system turned Grünenthal’s 29-day excursion data evaluation into a same day automated process
- Why this process will have an impact on the future of drug development
Xtalks Partner
Suvoda
Suvoda solves complex patient randomization and clinical supply chain challenges, so that customers have the peace of mind to focus on their patients. Suvoda IRT with Trial Intelligence (IRT+TI) offers speed, agility, and insight to handle the most complex clinical trials with ease, offering a comprehensive solution to optimize and manage the supply chain across the breadth of the clinical trial continuum.
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