Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.
Study Concept
More than half of Sponsors come to tech companies AFTER they have developed the entire protocol
Questions To Ask
- What tools and technologies are needed to support required data collection?
- How will data be monitored, and how will quality and completeness be ensured?
- How will data visibility be maintained across sites, EDC, sponsors, and partners?
- What is the change management strategy, and how will it be maintained throughout the study?
- Will systems be interoperable across technologies, EDC, sites, and data management vendors?
- What additional benefits or capabilities does the technology provide beyond its primary use?
- How will missing data be defined, monitored, and handled analytically?
- How will real-time or near real-time data access be enabled for key partners?
Why involve technology, data, and device partners now?
Engaging technology, device, and data partners during the study concept phase—often as endpoints and study activities are being defined—helps ensure that scientific objectives are feasible and measurable within real-world operational constraints.
Early collaboration aligns endpoint selection, data collection strategies, and operational workflows with available and validated technologies, reducing the risk of redesign, protocol amendments, and downstream execution challenges. Connecting these partners with sites early also supports usability, adoption, and data quality throughout the trial.
In addition, early involvement enables proactive planning for interoperability, data flow, and system integration across platforms, as well as the development of practical change management strategies. This is especially important in complex trials or when multiple vendors or a CRO are involved, where coordination and alignment are critical to maintaining study quality and timelines.
What aspects of the study concept should they inform?
- Endpoints (feasibility of measurement, digital/remote capture)
- Schedule of events (alignment with technology workflows and burden)
- Data collection strategy (including RWD and digital endpoints)
- Data flow and system integration (EDC, devices, platforms)
- Site and patient usability considerations
- Change management approach
Tech, Device, and Data Company Resources
A Smarter Approach to Clinical Trial Design and Delivery
Using digital technologies in clinical trials: current and future applications
Embracing Hybrid Trial Design - How, When, & Why To Use It
Artificial Intelligence for Clinical Trial Design
Clinical Trial Management Systems