Archives: Agenda

• Mapping critical risk points across the clinical trial lifecycle and identifying early operational signals before they escalate into issues
• Strengthening Sponsor–CRO–site collaboration through structured communication pathways and performance monitoring frameworks
• Shifting from reactive to proactive management by embedding contingency thinking throughout trial execution to safeguard timelines, data quality, and study outcomes

There are many aspects to moving from early research to clinical delivery under one roof. Using Ribocure as a case study, this session explores the practical realities of building clinical operations and establishing an in-house Phase II unit.

• Building and scaling a clinical operations function
• Talent, structure, and service provider strategy
• Establishing an in-house Phase II unit: key considerations and patient recruitment

• Understanding stakeholder expectations for AI in clinical research
• Practical steps for integrating AI into study design and operations
• Ensuring data quality, transparency, and regulatory compliance
• Measuring adoption, engagement, and return on investment from AI initiatives

• Rising scientific and operational complexity is reshaping global biotech
• Biotech confidence is strong despite escalating funding and R&D pressures
• AI and modern trial designs are accelerating development and decision making
• Operational discipline, especially protocol quality, now drives timeline performance
• Integrated CRO partnerships enhance predictability across the development lifecycle

Have you ever wondered what the future holds for clinical operations? Currently the industry is laser focused on decentralised trials, patient diversity, risk-based monitoring, real world evidence and digitalization but where, exactly, is all this going to lead? More importantly how can we prepare for what lies ahead? Based on experience, and market and business intelligence Bernhard will dare to give us a glimpse into the future by:

• Exploring the challenges to come
• Recommending solutions to implement now, in preparation for tomorrow

• Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
• Balancing cost, quality and timelines within tight budget constraints
• Negotiating contracts with flexibility to protect your biotech’s goals

Building out the RFI? What you outsource, what you need, and how many site visits? AI

• Extracting and standardizing key details from unstructured vendor documents
• Identifying inconsistencies, omissions, or gaps within proposals
• Supporting decision-making while safeguarding confidentiality and protecting intellectual property contained in submissions
• Case Study

Moderator: Silvana Giro, Senior Management, Global Medical & Regulatory Affairs, Bracco Imaging