Archives: Agenda

What is Patient Experience Data (PED)?

With a focus on clinical trials, and a data management perspective, Ane will cover study design considerations, patient burden, missing data and other challenges

• 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

• 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

• Selecting the right dose in line with FDA guidance
• Sharing implementation methods within study designs and protocols
• Highlighting challenges and successes

• Opportunities for CDMOs, sponsors, and suppliers
• Clinical trials: what to expect?
• Impact of the Biosecure Act
• Trends in outsourcing clinical trials – supply chain disruption

• 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

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