Archives: Agenda

• Optimize employ effort
• Minimize waste and risk
• Appreciate significant savings
• Sustainably friendly

• New regulations and guidance around clinical trial supply in the US: what do you need to know?
• AI and machine learning in clinical supply: what’s working, what isn’t and where are there new opportunities?
• Navigating change and unforeseen circumstances: how can you reduce impact to your supply chains?
• Assessing the clinical trial supply industry’s success in meeting sustainability targets

MODERATOR: Paul Hingst, Supply Chain Consultant, Crinetics

Cell and Gene Therapy (CGT) pioneers require supply chain partnerships that deliver experience in mitigating trial risk and complexity, along with a consultative approach to protocol execution. In this presentation, we’ll explore how integrated response technologies can be leveraged to:

• Optimize pre-trial and pre-screening activities for greater trial efficiency
• Overcome logistical challenges and ensure quality in the management of CGT trials
• Reduce trial costs and support sustainable CGT success

Introducing IMMUSE®, an award-winning and innovative postbiotic for immune health. This well-researched and effective ingredient will empower beverage manufacturers to elevate their functional drinks that resonates with health-conscious consumers. By incorporating IMMUSE®, you not only boost your product’s immune-supporting benefits but also align with the latest trends in wellness and innovation. Learn how IMMUSE® can be seamlessly integrated into your beverage formulations, providing a competitive edge and meeting the growing demand for functional, health-promoting drinks.

• Endorsing risk-based approaches: Encouraging sponsors to tailor their frameworks to the complexity, scale, and inherent risks of the study to ensure trial data integrity
• Discussing perceived challenges associated with RBQM implementation
• Learn about new comprehensive approaches to assessing RBQM
• Tangible use cases of RBQM adoption and how to meet RBQM standards

• How can sponsors and CROs leverage these updates to enhance the quality and efficiency of clinical trials?
• What are the ways we can pivot our trials to be regulation compliant and what do we need to prioritize?
• How the revised regulation encourages a risk-proportionate approach and a culture of quality that better accommodates ongoing innovation
• What the shift to a RBQM mindset means for the future of clinical data management

• Why traditional role boundaries slow down data quality and delivery
• Shared ownership across the data pipeline leads to faster, cleaner outcomes
• Leveraging standards to reduce rework and clarify expectations
• Using shared metrics and dashboards to stay aligned throughout the process