Archives: Agenda

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

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

• 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

• 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

• It’s no longer a question whether digital transformation will happen—it is how fast we can scale it.
• When innovations such as eSource/EHR-to-EDC operate at full swing, it will allow us to perform research that otherwise wouldn’t happen and to develop medicines that otherwise would never make it to the patient
• Scaling up the technology opens new avenues for collaboration, involving pharmaceutical companies, hospitals, along with technology vendors and academic partners.

• There is no “best model” – but there are wrong ones
• Sponsors owning systems ≠ control if operations sit with CROs
• CRO-owned systems ≠ efficiency if oversight is weak
• The real question is not ownership – it’s control of data, processes, and timelines
• System ownership decisions directly impact: inspection readiness, study startup speed
• Case study: SOLTI’s transition from legacy Oracle to modern SaaS
• What Solti would do differently today

Despite decades of experience implementing electronic clinical outcome assessments (eCOAs) in clinical trials, we continue to grapple with the same operational challenges during set-up and implementation. They’re solvable – yet they persist. Why?

This presentation will discuss key barriers that continue to slow progress, including:

• Licensing and copyright holder review processes
• Perceived need for screenshots for IRB/EC submission
• Fragmented stakeholder collaboration and lack of true partnership
• Unbalanced expectations – electronic vs paper, BYOD vs provisioned
• Missconceptions around regulatory expectations

By addressing these challenges head-on, and fostering genuine collaboration, we can solve them if we truly want to gain efficiencies and optimisations in clinical trial set-up.