Archives: Agenda

With drinks and refreshments, interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run twice and be led by a table moderator and will focus on a different challenge within clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

• Working closely with FSP vendors: how much oversight do you need?
• Benefits and challenges of moving to an FSP outsourcing model
• Comparing vendor management strategies between pharma and biotechs: do you need a different approach?
• Why is FSP becoming a popular outsourcing model: what benefits can this offer sponsors?

Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData

• Determining team bandwidth
• Assessing clinical trial needs
• Shopping for the right CRO(s)
• Lessons learned from outsourcing

• Setting up for success with large CROs in terms of contract structures, financial terms and governance from a small biotech perspective
• Implementing a gold standard strategic partnership to avoid common pitfalls and improve vendor selection
• Knowing when to outsource and detailing key activities to be performed for each vendor service to ensure proper oversight
• Factoring in necessary contracts and approvals for vendor selection in study timelines

Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

• Predict high-performing sites and investigators to accelerate enrolment
• Forecast site activation timelines with greater accuracy
• Anticipate post-marketing commitments earlier in the process
• Enhance TMF compliance and quality through intelligent automation
• Accelerate and streamline site contracting for faster study start-up
• Drive operational efficiency and cost savings through robotic process automation

• When the demand for research sites is growing and supply is failing to keep up, what can be done for competing trials?
• Dealing with exorbitant startup fees imposed by sites, with no guarantee of patient enrolment
• Elevating site support with comprehensive budgets and accelerated site payments
• Enabling appropriate technology for sponsors to easy access patients’ EMR
• Working to identify “hidden” costs and trial efforts that sites may not anticipate before negotiations
• Overcoming outdated paradigms that threaten site-sponsor relationships
• Carving out a niche to set you apart from the crowd to enable access to sites and patient populations

• Growing in a thoughtful manner to ensure FDA inspection readiness
• Allowing future studies to benefit from standards established and remained consistent right from the start
• Engaging in respectful partnerships and supporting a demand-driven basis, aligning with country-driven strategies and procedures

• Tips and tricks to negotiate better contracts with sites and vendors
• Clinical trial budgeting and operational oversight from the financial perspective

• FDA’s expectations from site and sponsor’s documents
• Required components of TMF
• Best practices for the set-up and maintenance of TMF
• Tools and SMEs