Archives: Agenda

• Strategies for sourcing components from a scattered ecosystem
• How to develop meaningful, human-centric measures
• Pitfalls and opportunities for analytical and clinical validation
• Novel solutions and digital pathways for scalable regulatory qualification
• Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

• Understanding regulation and preparing compliance
• Driving innovation and technology into processes through use of generative AI
• Implementing AI for practical use with valuable return on investment

• Considering, generally and specifically, data collected with eDiary, CGM and other external sources
• Assessing risks when outsourcing trials
• Acting accordingly to manage and mitigate risks
• Maintaining right level of oversight

• Pro-actively preparing for the worst up front
• Considerations for changing or re-assessing sites
• Assessing, selecting and switching vendors: benefits and challenges
• Case study example: success and lessons learnt

Clinical trials follow a formula, but their success is about more than science. How can sponsors maximise their communications opportunities to stimulate and maintain the passion and proactivity that are key to the success of their study, among site staff with competing priorities, who may feel they’ve seen it all before

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Mitigating risk in clinical supply chain
Pernille Hemmingsen, Chief Technology Officer, Adcendo

Roundtable 2
Engaging with CROs: defining deliverables and agreements
Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

Roundtable 3
Considering DCT trial design and impact on both the patient and company
John Zibert, Chief Medical Officer, Coegin Pharma

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

Roundtable 1
Mitigating risk in clinical supply chain
Pernille Hemmingsen, Chief Technology Officer, Adcendo

Roundtable 2
Engaging with CROs: defining deliverables and agreements
Asger Dahlgaard, VP of Quality Assurance and Regulatory Affairs, BioPorto Diagnostics A/S

Roundtable 3
Considering DCT trial design and impact on both the patient and company
John Zibert, Chief Medical Officer, Coegin Pharma