Archives: Agenda

• Advantages of using a data-focused CRO and technology to manage data related activities
• Simplifying process and leveraging efficiencies to reduce risk and cost
• Understand key gateways to ensure quality and coordination
• Sponsor perspective and benefits of outsourcing models

• Understanding the requirement and options for declaring biological materials to U.S. Customs and Border Protection (CBP)
• Review of key U.S. regulatory agency authorities, such as CDC, FDA, USDA, and CBP
• Discovering the latest non-compliant shipment issues for biological materials and pharma products and tips to avoid them
• Learning about valuable resources and contacts for assistance

• Technology and new developments when it comes to managing CRO relationships
• How to ensure your study is prioritized
• Maintaining a strong relationship with vendors in remote and hybrid work settings
• How to blend a CRO team with your internal team in order to foster communication and overall success of your trial
• CRO monitoring and oversight: how to make processes efficient and effective

• Ensuring your trial is cost-conscious and efficient without compromising on quality or on patient care
• Forecasting and budgeting in order to accurately predict costs and minimize unforeseen expenses
• Keeping your clinical budget on track
• Negotiating prices and contracts in order to ensure maximum benefit without going over budget

MODERATOR
Rene Stephens, Managing Director, Clinical Business Operations, Danforth Advisors