AGENDA

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Topics Included:

• Review of AQC workstreams:
  • Site Centricity
  • Inspection Readiness
  • Provider Qualification Standards and Tools
  • Risk-Based Quality Management
• Hands-on, deep-dive workshops:
  • Quality Tolerance Limits – Unraveling the mystery of QTLs.
  • Risk-based Inspection Readiness – Utilizing dashboarding and metrics to track inspection readiness real-time. (AQC Members only)
  • Enhancing Site Quality – Enabling site feedback at study design and other implementable ways to increase quality and compliance at investigative sites.
  • De-mystifying Decentralized Trial Qualification – Avoca’s work in prequalification helps the industry qualify technology providers who are assisting in capturing data for traditional or decentralized clinical trials. Learn how to qualify vendors in the current climate of uncertainty in regulatory requirement interpretation. (AQC Members only)
• Discussion on how clinical trials are changing in light of new technologies and what we can look forward to as an industry. Discussion will include digitizing clinical trials using wearables, best practices, and perspectives on what is required of sponsors.
• Panel discussion on risk management and mitigation as new wave of technologies are developed to support clinical trial execution.
• Panel discussion on clinical research merging with patient care and how technology impacts the patient experience. Panelists will discuss how the industry’s role in patient engagement can evolve as the approach to clinical trials evolves.
• Discussion on the future of clinical research as a care option.
• Patient engagement activities that will be necessary to ensure the survival of an industry that relies on volunteers.
• Preliminary insights of the Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with The Avoca Group, have established a working group to benchmark the vendor qualification assessment process and identify improvement opportunities.
• Plenty of time for networking and collaborating with other attendees.