Archives: Agenda

• Begin with the end in mind: Termination Clause
• Identify and access file repositories
• Understand PII and security requirements
• Close out projects in the storage phase
• Secure vendor-backed documents and files
• Reconcile finances and finalize invoices
• Issue termination letters
• Complete contract close-out

• Aligning the clinical trial ecosystem to be operationally efficient and reduce delays in supply deliverables
• Fine-tuning the clinical supply vendor partnership: How can sponsors and service providers start using guidance in totality instead of in silos?
• Maintaining open communication with manufacturers to address precise trial needs and perfect demand planning
• Working in tandem across the trial ecosystem to better manage demands for increasingly complex clinical supply needs

• Aligning vendor expertise with study needs
• Assessing operational transparency and communication
• Balancing innovation with compliance

• Showcasing and defending the clinical operations strategy and outcome for pivotal studies during Sponsor regulatory inspections as the culmination of years of intense and important work; or the “Super Bowl” of Clinical Operations
• Sharing best practices based on real-life examples, for surviving and thriving during FDA and EMA Sponsor regulatory inspections from the Clinical Operations viewpoint
• Collaborating with QA and other cross-functional partners for success
• Best practices in logistics and Clin Ops teamwork in advance of, during and after the inspections
• Common, recent findings related to Clinical Operations during inspections

• Uncover and understand stakeholder and vendor business requirements
  • Who’s bringing what to the party?
  • Quality/Speed/Price
• Various development phases and vendor types
  • Business risks
  • Legal considerations
  • Vendor types
    • Early research/ development
    • CROs
    • Clinical sites and collaborations/HCPs
    • CMO/CDMOs
• Escalations and governance as a safety net

• Learning criteria for identifying investigator aligned with study goals, device expertise and regulatory expectations
• Building relationships at clinical sites
• Effective training for investigators and site staff
• Optimizing the informed consent process

Data plays an increasingly critical role in the age of AI in life sciences. Using data and AI effectively can help:

• accelerate research & development by making new and larger data points easily accessible
• optimize trial design and enrolment by analyzing population and patient characteristics
• improve manufacturing efficiency and commercialization

• DEI considerations: How can we establish trust within less-represented groups?
• How can patient advocacy groups remain at the forefront of the discussion on study design and tailored communication programs
• Overcoming obstacles in recruiting pediatric patients and how to make it easier for them and their parents to participate
• Ensuring optimal communication with sites to support their efforts
• The need for clinical trials to be accessible to patients

Chair: Ros Cheetham, Vice President, Clinical Operations, MacroGenics

• Battling site competitiveness to reduce delays on study start-up: what can you do differently to tackle these operational challenges?
• When there are immense pressures on the trial ecosystem, how can we build quality and ensure quantity in an innovative way
• Developing an optimized strategy as a small to medium-sized biotech with limited resources to stay afloat
• Discussing the importance of protocol optimization and specialized statistical support to reduce the pressure on sites and relieve bottlenecks

Chair: Susan Edelstein, PhD, SVP, Clinical Research, Ardelyx