A design thinking approach to exploring automation technologies in clinical development operations
Ian Shafer, PricewaterhouseCoopers
In this first part of this session PwC will provide educational introduction to several automation technologies, including robotics process automation (RPA), machine learning (ML), and artificial intelligence (AI). We will describe the individual characteristics of each technology, including strengths and limitations, as well as practical uses of these technologies. In the second part of the session, PwC will lead a series of activities, using design-thinking techniques to identify pre-competitive opportunities in the clinical development process where automation technologies can have the most impact, followed by a team effort to co-create and refine selected automation use-cases. At the end of the session, a contest will be held where all participants will vote for the top three use cases.
- Learn fundamentals of advanced analytics, robotics process automation, machine learning, and artificial intelligence.
- Learn about characteristics of each technology, appropriate use cases and best practices
- Identify practical and pragmatic uses cases for the applications of automation technologies within clinical development
- Leverage design-thinking approaches in team settings to elicit and co-create use cases
Preparing Data for a Regulatory Submission
Fred Wood, Data Standards Consulting Group
Requirements exist for the submission of standardized electronic study data to the FDA. This workshop will summarize the regulatory basis for submitting such data, provide an overview of the standards that govern such submissions, and discuss the additional support files necessary for a complete submission.
- Understand the regulatory basis for the requirements for electronic data and standardized electronic study data
- Become aware of the specific data standards the agency expects
- Recognize that additional documents/files are required to support the submission of study data
Please note that this preliminary program is subject to change.