- 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
Archives: Agenda
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
Lunch and networking
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
CEO PANEL DISCUSSION: Fundraising in the real world — Lessons, pivots and pitfalls
Moderator: Jeff Trickett, Business Advisor, Archetype Therapeutics
Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research
Afternoon refreshments, networking and prize draw sponsored by Dr. Vince Clinical Research
When innovation doesn’t go as expected
- 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?
PANEL DISCUSSION: How can smaller biotechs achieve scalability when resources are tight
- Accomplishing the right vendor selection to ensure better equipped budget and overhead wise for smaller companies
- Optimizing boutique service providers to guarantee the flexibility and attention you need for study start up
- Building the appropriate infrastructure needed to scale up clinical research and knowing when to invest in outsourcing services
- Looking at the latest technologies which are demonstrating that scalability is a solvable problem
- Having a comprehensive understanding of global requirements and timelines
Chair: Robert Loll, SVP, Business Development & Strategic Planning, Praxis