Unlocking the Future of Clinical Trials with Protocol AI and Digital Data Flow
Clinical trial protocols are foundational documents that define the requirements and parameters of clinical trials. However, protocols today lack a standardized, machine-readable format that facilitates seamless exchange across diverse systems. On average, there is a four-month delay between protocol approval and study start-up.
The Digital Data Flow (DDF) initiative by TransCelerate and CDISC offers a promising opportunity to standardize protocols, providing the following benefits:
- Eliminating non-value-added activities through automation: "Work Smarter, Not Harder."
- Enabling flexible company and industry-wide interoperability by applying clinical protocol standards.
- Laying the foundation for advanced study design analytics and insights.
Starting with the Unified Study Definitions Model (USDM), an industry-standard data format used in study design, the DDF initiative provides a pathway to digitize clinical study components. This approach enables automation, interoperability, and reuse across the clinical study lifecycle.
As part of the DDF Solution Showcase series, TransCelerate and CDISC will co-host a webinar on December 5, 2024, from 9:00 to 10:30 a.m. EST. This event brings together sponsor companies, clinical solution providers, and key industry stakeholders.
In this session, our CEO, Poorya Amini, will demonstrate how Protocol AI empowers experts to build ICH M11- and USDM-compliant digital clinical trial protocols from scratch—without disrupting the existing workflows of clinical development or medical writing teams.
This public event is free to attend. The agenda and registration form can be found here:
Don’t miss this opportunity to learn, network, and explore the future of clinical protocol development!