Event Schedule
- Communicate the level of validation needed in order to make claims on data
- Upgrade due diligence around the technologies that clinical trial teams must have in place
- Bridge gaps in levels of inherent knowledge
- Explore select differences in launching hybrid decentralized studies in Europe, Asia Pacific and South America
- Discuss flexible approaches for eConsent, telehealth, eCOA sensors and home health
- Review lessons learned to date with global DCT expansion
Speaker:
- Reduce the need for site visits through at-home monitoring
- Gather and reliably archive patient feedback on drug formulation and delivery
- Turn a challenging time into new opportunity, with trial structures that more easily fit into patients’ routines
- Explore the potential of remote models
- Recognize and adapt to burdens and complexities of multiple stakeholders
- Evaluate vendor capabilities to move beyond virtual sites and take on both CRO and site capabilities
- Understand the regulatory guidance available and consider the implications to the regulatory strategy for products that use these novel approaches in clinical trials.
- Utilize novel approaches to clinical trials within a context of COVID-19
- Explore the US FDA guidance documents published related to COVID-19 pandemic and provide regulatory insights as to moving forward in our ‘new normal’ of clinical trial development.
- Leverage a single destination for all trial virtualization technologies
- Incorporate and harness the patient voice in the design of a decentralized trial
- Improve patient access to clinical trials using registries
- Review how the industry combines conventional strategies with virtual trials
- Restructure internal processes as needed for implementation
- Investigate the most cost-effective applications and outcomes
- Analyze how digital health tools can move trials forward
- Ensure the data integrity and subjects' safety monitoring in the virtual clinical trials implementation
- Explore areas requiring change in order to drive sustaining adoption in the organization
- Discuss specific examples spanning processes, vendor selection, training and protocol authoring
- Share experiences managing organizational change to recognize pitfalls and drivers of success
Speakers:
- Sharon TerryPatient Advocate, Founder and CEOGenetic Alliance
- Hassan KadhimDirector, Global Head of Clinical Trial Business Capabilities and Clinical InnovationBRISTOL MYERS SQUIBB
- Mike CollinsSenior VP, Clinical Operations & Data SciencesAKEBIA THERAPEUTICS
- Craig LipsetFounderCLINICAL INNOVATION PARTNERS
- Hear the insights gained from designing and implementing transformational solutions for the new era that will propel the future of drug development
- Discover how to use a lens of business-to-consumer product evolution
- Examine actual client needs from this past year as case studies showing how we can shape an “Amazon experience”
- Identify and increase focus on patients and evolving customer needs to deliver solutions that are relevant and long-lasting
- Outline how the proper technology choices can help or hinder you
- Compare and contrast technical platform options
- Focus on the clinical trial without commercial consideration
- Evaluate the benefits of virtual meetings in terms of cost and convenience
- Compare different methods for gathering information through “breakouts
- Review new outreach options for CRAs and training
- Clarify in advance the needs for tech support
- Explore the most up-to-date options for large-scale data analysis for virtual trials
- Address common mistakes and misperceptions
- Clarify what is realistically possible for digital health and bioinformatics in a remote setting
- Determine the most important indicators of site quality
- Plan creative collaboration and flexible strategies
- Find the fastest techniques for site quality maximization
- Recognize how behavior influences team results