Pre-Conference Workshops

Reinventing Clinical Data Management in a Generative AI and Digital Dataflow Future

Sept. 29 - 8:00 AM to 12:15 PM

Part 1: Panel discussion: This workshop will highlight the critical need for clinical data professionals to stay current with GenAI technologies. Through panel discussions with industry thought leaders, participants will receive an overview of the technologies (Generative AI, Protocol Digitization, Digital Dataflow, Direct Data Capture) helping reinvent Clinical development.

Part 2: Demo: Harnessing LLMs for Study Start-Up and Build Activities: Through a Pfizer-Saama demo led session, participants will gain practical experience in applying GenAI to clinical data management activities, exploring real-world use cases in study start-up and build such as: UC1: Protocol Digitization, UC2:Study Build UC3: Specification Automation and UC4: Synthetic Test Dataset Generation. An innovation lab environment has been set up to demo with access to LLMs so that the audience can experience the various prompt techniques to solve these use cases.

Part 3: Group activity session: This part of the session is a group activity with interactive discussions, participants will collaborate to identify current opportunities with GenAI, discuss future opportunities and how to redefine / pivot organizations to usher in the next era of clinical development with GenAI. Attendees will be equipped with the required skills and knowledge to take back innovative ideas, fresh approaches to solve them and a better understanding of the art of the possible and limitations of LLMs for Clinical Data Management challenges!

Dan Crawford of Veeva & Dawn Kaminski of eClinical Solutions

Data Requirements for an FDA Submission

Sept. 29 - 1.15 – 5.15 PM

This workshop will provide an overview of the requirements for submitting standardized electronic data and documents to Regulatory authorities (FDA). We will also highlight some of the tools the FDA uses to facilitate their review and their approach to reviewing the safety and efficacy portions of a submission.

Lisa Lions of J&J Innovative Medicine, Joy Allen of the PCCT - Memorial Sloan Kettering Cancer Center, Jayasmita Dutta & Sujata Aiyangar of Accenture

Mirror, Mirror... Be Real, Be You. Reflecting Your Authentic Self

Sept. 29 - 1.15 – 5.15 PM

In today's dynamic and competitive business environment, the ability to stand out as a leader hinge on more than just technical expertise. The ability to look inwardly, with a focus on personal branding and soft skills are pivotal for leaders aiming to drive success, inspire their teams, and foster innovation. This interactive 4-hour workshop, "Mirror, Mirror: Be Real, Be You. Reflecting Your Authentic Self," is meticulously designed to equip participants with the strategies and tools necessary to enhance their personal brand and develop key interpersonal skills that are essential in the modern business landscape.