- Determining team bandwidth
- Assessing clinical trial needs
- Shopping for the right CRO(s)
- Lessons learned from outsourcing
Archives: Agenda
Practical ways ICON is using AI to address common delivery pain points
- 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
Fine-tuning the site-sponsor partnership by aligning strategies and fostering ongoing communication and flexibility
- 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- Overcoming outdated paradigms that threaten site-sponsor relationships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
Engaging in successful partnerships with the U.S. NIH
- 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
Best practices for clinical trial execution from a financial perspective
- Tips and tricks to negotiate better contracts with sites and vendors
- Clinical trial budgeting and operational oversight from the financial perspective
Trial Master File (TMF): Expectations from Sponsors, CROs and Sites
- 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
PANEL DISCUSSION: Selecting the right partners to leverage new technologies in clinical research
- Understanding the risks and opportunities in collaborating with technology providers to drive innovation in pharma
- Key criteria in vendor selection: How important is therapeutic area knowledge when choosing CROs and partners?
- Balancing patient, site, CRO and investor priorities in your trial design
- Navigating the outsourcing landscape: An overview of new tools and solutions available on the market
Moderator: Amanda Murphy, Senior Director, Data Intelligence & Solutions, GlobalData
Lunch and networking
CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls
Moderator: Jeff Trickett, Business Advisor, Archetype Therapeutics