Archives: Agenda

• 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

• 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• Overcoming outdated paradigms that threaten site-sponsor relationships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

• 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

• 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

Moderator: Jeff Trickett, Business Advisor, Archetype Therapeutics

• A case study from WinSanTor
• How to best implement innovative e-clinical software systems to ensure they work within the service provider universe
• A harmonious partnership: Balancing innovation and data safety
• When service providers have too much power, how can we ensure innovation isn’t stifled?