Archives: Agenda

• 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

• Creating a risk management plan for clinical supply chain
• Considerations for security risk management
• Preparing for unexpected and natural disasters
• Monitoring temperature control risk management

• Highlighting challenges and impacts of rising global supply shortages
• Realising urgent need to increase sustainability and life cycle of drug products to avoid limiting innovation due to shortages
• Overcoming shortages to keep your trial on track

• Collaborating early with clinical operations to align needs and outcomes
• Considering tools and processes to assist with cross functional interaction
• Liaising with quality assurance to enable faster compliance and reduce delays

• Identifying key characteristics of IRT required for different study types
• Handling dispensing protocols, calculating dosage, predicting demand and inventory management
• Controlling dispensing logistics to track your product during shipment and patient distribution to maintain control over your clinical study
• Managing documentation including returns, reconciliation and accountability for drug

The landscape of clinical trials is rapidly evolving, driven by technological advancements and a shift toward patient-centric methodologies. This transition is marked by a growing emphasis on decentralization and personalized healthcare, resulting in more accessible and tailored clinical experiences for patients. Hybrid models that blend traditional site-based methods with decentralized strategies are increasingly being adopted to meet these demands and operational innovations are being developed to address the unique challenges presented by new therapeutic modalities.

This presentation will explore the profound impact of these developments on clinical trial supply chains and trial planning, highlighting how the integration of cutting-edge technologies and innovative strategies can significantly improve operational efficiency and elevate the patient experience.

Discussion topics:

• The changing clinical trial landscape and the potential for faster delivery of life-saving drugs to patients
• The role of smart technologies, deep learning, and artificial intelligence in streamlining clinical trial supply chains
• The impact of decentralized and hybrid trial models on patient accessibility and convenience
• The adoption of direct-to-patient digital capabilities and real-time track and trace systems for end-to-end visibility
• The use of AI and historical data for proactive and predictive analytics to enhance trial planning accuracy and efficiency