In today’s connected world Clinical Trials are embracing technical innovations to help organizations make confident informed decisions, faster. Since the outbreak of Covid-19 sponsors are adopting and embracing technologies at a speed that would have been unimaginable a few months ago. As a part of this effort, many organizations are embracing eSource and Direct Data Capture to collect data directly from the subject at the time of the visit and when possible at home. As a result of this, this presentation will focus on what organizations can do to help ensure the accuracy of their data as well as compliance with all applicable regulations on data privacy and handling from the initial direct collection of the data all the way to its submission. Targeted review and centralized data review will be discussed and highlighted as part of helping organizations embrace a direct data capture approach to clinical trials taking recent regulatory guidance by health authorities into consideration. Q&A with the audience.

Key takeaways for our audience:

Key folks who should attend:

- Data Management & Biostatistician
- Clinical Operations/Outsourcing/Innovation
- (Digital) Health Outcomes

MassBio makes every effort to accommodate our entire community at each of our events. Please let us know at least 3 days in advance of the event if you require special accommodations, such as captioning.

Sponsored by our Clinical Development, Data Management and Biostatistics working group. Thank you!