Archives: Agenda

• Sharing insights on collaborations with clinical CROs on previous clinical studies
• Preparing for a clinical trial with a University Hospital in Denmark
• Choosing and developing the right trial design

• Planning and scheduling considerations
• Understanding the requirements and importance of chain of identity and chain of custody within cell therapy trials
• Vetting critical partners and identifying technology tracking systems to assist with cell therapy supply

• Assessing outcomes from over 70 interviews with life science industry pioneers
• Reviewing what clinical professionals wish would be different in the life sciences industry
• Suggesting next steps towards further evolving clinical trials

• Overview of global clinical trials for 2023
• Assessing key sponsors, top interventions and looking at the trial landscape for 2023
• Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status

• We will examine the high cost of doing nothing
• What is the status quo and can technology help?
• Vendor management – tackling one of the biggest challenges
• The role that AI can play
• What you can gain by embracing technology

• Driving true benefits for clinical research through digital health technology
• Learnings from barriers created by integration of digital health
• Improving processes and focusing on delivering digital health as a tool

• Orphan drug market: Illustrate the unique challenges of developing a drug for rare diseases
• Patient-focused drug development: Designing patient-centered clinical trials
• Operational considerations: Endpoint selection; reducing the burden of participation; cost; sites; patient concierge services
• Collaboration: Focus on the need for collaboration in this space: sponsors, CRO (Clinical Research Organizations), patients, patient advocacy groups, investigators, vendors

• Digitalization: what can we digitalize to improve systems and processes
• AI: what can we implement to save time and resource
• Systems: what technology and systems are available and emerging to assist in clinical trials and data management

Moderator: Libbi Rickenbacher, Senior Director of Product Strategy & Partnerships, 4G Clinical
Panelists:
Stephen Lutsch, Senior Director Clinical Trial Digital Innovation, Genmab
Ane Jensen, Principal Data Manager, Zealand Pharma

Regulatory bodies are promoting Risk Based (Quality) Monitoring as a best practice in clinical trials to correct data quality issues as early as possible in the trial lifecycle.  Since this involves the identification of specific patterns in large datasets, artificial intelligence can support us in doing this efficiently.

• How can AI find specific patterns that humans might miss
• Interactions between AI and humans in RB(Q)M
• Real life examples in respiratory