- Creating a national partnership to enhance conditions for clinical trials
- Collaborating between healthcare sector, academia, and the pharmaceutical industry to make Sweden more competitive in conducting clinical trials
- Streamlining clinical study systems to improve efficiency and accessibility of clinical trials
Archives: Agenda
Applying product launch strategy to clinical trials: A reimagined approach to recruitment and retention (Stream A room onsite)
- Competition for patients in clinical trials is fierce, and putting the trial at the front of mind of PIs, site teams, referral networks, and patients is crucial to win in patient engagement
- A successful recruitment and retention strategy has to reach target HCPs and patients with accelerated precision through an engagement campaign that starts with an evidence-based point of reference, builds confidence in the trial, delivers a resonating call to action, and evolves as clinical insights start flowing in
- A new approach to recruitment and retention takes inspiration from ways of working within Medical and Commercial teams and produces durable outputs that evolve into the essentials of a product launch toolkit, facilitating organizational efficiency
Implementing FDA’s Project Optimus and reviewing the impact on trials
- Selecting the right dose in line with FDA guidance
- Sharing implementation methods within study designs and protocols
- Highlighting challenges and successes
Building resiliency in supply chains: Trends to watch
- Opportunities for CDMOs, sponsors, and suppliers
- Clinical trials: what to expect?
- Impact of the Biosecure Act
- Trends in outsourcing clinical trials – supply chain disruption
Lunch and networking sponsored by Hiro
Creating the first protocol design with AI: Shortening protocol design processes to less than 3 months (Stream A room onsite)
- How AI optimizes clinical trial protocols to reduce errors, streamline processes, and enhance data quality
- A Real-world case study of reduced timelines and improved trial outcomes using Biorce’s platform
- Insights into leveraging predictive analytics for trial success
Strong safety, lean teams: Practical pharmacovigilance strategies for biotech and pharma
Pharmacovigilance in clinical trials is a collective effort; however, for biotech and specialty pharma, limited resources and dynamic pipelines can make it more challenging to scale effectively. This session will provide a practical framework for defining roles, responsibilities, and oversight in PV, from sponsors and CROs to vendors and investigators. Attendees will learn how hybrid outsourcing models can provide flexibility and global coverage without overbuilding internal teams, and how strong partnerships transform PV from a compliance requirement into an enabler of trial success.
- Understand how pharmacovigilance roles and responsibilities align across sponsors, CROs, vendors, and investigators, and why clear roles prevent inefficiencies and issues
- Learn how biotech and specialty pharma can develop scalable pharmacovigilance strategies that adapt to dynamic pipelines
- Discover how hybrid outsourcing balances in-house oversight with external expertise for global coverage
- Explore methods to enhance partnerships so pharmacovigilance can support both compliance and operational delivery
- Recognize how a well-designed pharmacovigilance model can accelerate progress from early development to marketing approval
Registration and Refreshments
Gamification in clinical trials: A proven path to better engagement, retention, and data integrity
Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.
· Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation
· See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines
· Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols