Archives: Agenda

Navigating Phase 1 Trials: Strategies for Small Biotech’s to Overcome Financial and Resource Challenges

Small biotech companies often face unique challenges when conducting Phase 1 clinical trials due to limited financial and human resources. This session will explore practical strategies and tools that can help these companies effectively manage their trials while navigating regulatory requirements. Attendees will gain insights into optimizing trial design, budget management, and leveraging partnerships.

  • Understand the financial challenges faced by small biotech companies in running Phase 1 trials.
  • Explore strategies for effective resource allocation and cost management in clinical trials.
  • Learn about tools and technologies that can streamline trial operations and improve efficiency.
  • Discuss regulatory considerations and compliance best practices that impact trial management.

 

Expanding Access: How Community-Based Research Models Improve Patient Optionality and Inclusivity in Trials

In an increasingly complex clinical trial landscape, ensuring patient inclusivity and accessibility is critical to improving study recruitment, retention, and data quality. Traditional trial models often create barriers to participation due to geographic, financial, and logistical constraints – ultimately impacting trial outcomes. Community-based research models provide a scalable, flexible approach to engaging underrepresented populations while maintaining high levels of data integrity and protocol adherence. This session will explore how community-based research options can help sponsors and CROs design more inclusive trials. We’ll also discuss how addressing social determinants of health – such as transportation, economic stability, health literacy, and access to care – can improve patient participation and adherence, leading to more representative and meaningful trial results.

 

Maryleen Lovell-Petronilia, Quality Manager, PCM Trials

VIRTUAL SESSION: WHO’s clinical trial guidance: what do I need to know

  • Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
  • Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
  • Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
  • Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

Risk-Based Quality Management in Clinical Trials: Ensuring Compliance and Efficiency

This session will explore the principles, methodologies, and tools of Risk-Based Quality Management (RBQM) in clinical trials. It will focus on how a risk-based approach can enhance compliance, improve data quality, and optimize trial efficiency. Attendees will gain practical insights into risk assessment, monitoring, and mitigation strategies, with a particular emphasis on implementing RBQM frameworks in alignment with ICH E6(R3) guidelines.

 

  • Overview of RBQM: Concepts and Regulatory Frameworks
  • Designing a Risk Assessment and Categorization Tool (RACT)
  • Centralized and On-Site Monitoring Strategies
  • Leveraging Technology for Risk Management
  • Case Studies: Lessons Learned from Implementing RBQM
  • Future Trends and Updates in Regulatory Guidance

Optimising Drug Development through effective Paediatric Strategies

·       Why Paediatric Developments?

·       The Regulatory Landscape

·       Current Situation for Paediatric Research – Challenges and Possible Solution

·       Early Integration of Paediatric Considerations

·       Insights and Outcomes from Combined Adolescent-Adult Clinical Trials

·       Conclusion

Enhancing Patient-Centricity in Clinical Trials: A Collaborative Approach

This session will explore how patient centricity, engagement, and incorporating the patient voice can transform clinical trials.

  • Understanding the concept of patient centricity and its importance in designing and conducting trials.
  • Explore how patient involvement can enhance trial design, improve recruitment, and ensure adherence.
  • Highlighting the value of capturing patient insights to identify and address barriers in trial participation.
  • Discuss methods for incorporating patient feedback in protocol design, consent processes, and study execution.
  • Building Collaborative Networks, Examine the roles of investigational sites, industry sponsors, and regulators in fostering a patient[1]centric approach. • Identify best practices for stakeholder collaboration to streamline trial processes while keeping patients at the forefront

AI in Clinical Trials: Practical Implementation, Navigating Uncertainty, and Measuring Success

This session will offer a deep dive into the practical applications of artificial intelligence (AI) within clinical trials and research settings. Moving beyond theory, we’ll focus on implementing AI solutions, addressing the challenges of navigating the unknown, and defining clear metrics to measure success.

  • Identify key AI implementation areas in clinical trials and the tools available and how can the sponsor benefit from such tools
  • Understand methods to assess and measure AI-driven initiatives’ success.
  • Learn techniques for navigating uncertainties and overcoming implementation challenges.
  • Gather and utilize feedback effectively to optimise AI solutions.