UAT and Risk Mitigation:
Insights from Global RTSM Experts and Cutting-Edge Pharma
About this webinar
In the dynamic landscape of clinical trials, ensuring efficient and compliant User Acceptance Testing (UAT) processes while mitigating risks is crucial. In this engaging webinar, leading technology vendors, 4G Clinical and Poxy Clinical, collaborated with renowned pharmaceutical company, Vir Biotechnology, to present their approach in supporting complex trial UAT. The webinar will explore the interpretation of regulations, the implementation of GAMP 5 guidelines and the integration of best practices from this partnership. This insightful webinar aims to assist sponsors on their UAT journey while minimizing potential risks.
During the webinar, the featured speakers will also highlight how efficient and enhanced UAT processes allow sponsors to concentrate on core aspects of the trial. By fostering a more efficient and inclusive UAT experience, this collaborative approach not only supports risk mitigation efforts but also contributes to optimized and compliant clinical trials.
Join the speakers to gain valuable insights and strategies for enhancing UAT processes while minimizing risks.
Who should attend
- Pharmaceutical Companies, Biotechs and CROs
- IRT/IXRS Managers
- Clinical Operations
- Clinical Supply
- Medication Supply Managers
- System Validation
- UAT Consultants
What you will learn
Attendees will gain insights into:
- Understanding regulations and implementing GAMP 5 guidelines
- Facilitating collaboration between technology vendors and pharmaceutical companies during the UAT process
- Enhancing UAT processes for efficient and compliant clinical trials
Featured Speakers
Jordan Clark
Jordan Clark has worked in Clinical Operations on the Sponsor side since 2016. She has been with Vir for over four years, having experience in several therapeutic areas at the biotech organization and multiple collaborations with 4G and Poxy Clinical.
Susan Vong
Susan Vong, President of Poxy Clinical, UAT Services, brings over 16 years of experience leading design, development, testing and implementation of life sciences technology in the pharmaceutical industry. She is an innovator committed to pioneering a new standard in life sciences and founded Poxy Clinical to address the much-overlooked phase of UAT, enhancing speed and quality to clinical trials technology for over 20 sponsors and counting. Before founding Poxy Clinical, Susan held clinical technology leadership roles at Genentech, Amgen, and Sunovion.
Savannah Alford
Savannah Alford is a Delivery Operations Manager focused on the successful implementation of Prancer RTSM. She is experienced in bridging communication gaps between technical and clinical study teams and designing RTSM solutions. Savannah holds a Bachelor of Science in Microbiology from Oregon State University and a Master of Science in Healthcare Management from Oregon Health & Science University. Savannah enjoys teaching others and problem-solving.
Helen Le
Helen Le is Senior Director, Quality Operations at 4G Clinical. Helen has over 18 years of experience in clinical research working for contract research organizations. She has a proven track record in delivering clinical trials and providing support to clients with their regulatory submissions. Helen has also been involved in the design and compliance of software solutions developed for use in medical imaging clinical trials. Helen earned a Bachelor’s degree in Biology from Boston University.
Partners for this event
4G Clinical
4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in Wellesley, MA, with offices in Europe and Asia. Learn more at www.4gclinical.com.
Poxy Clinical
As a trusted partner for companies conducting clinical trials, Poxy Clinical is the global leader in delivering User Acceptance Testing (UAT) to validate that Randomization and Trial Supply Management (RTSM / IRT) systems are accurate, efficient, and patient-centered. Poxy Clinical is a women-owned business located in Cambridge, MA. Learn more at www.poxyclinical.com.
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