Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: April 29, 2025
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Helpful Terms and Definitions
Study Concept
More than half of Sponsors come to tech companies AFTER they have developed the entire protocol
Questions To Ask
- What tools are needed to achieve the requested data?
- How will data be monitored?
- How can all parties have data visibility from the site through EDC and Sponsor?
- What is the change management plan/strategy?
- How can change management be a priority throughout?
- Will there be interoperability between the tech and EDC, sites and data management companies?
- What are benefits of tech solution beyond assumed use?
- Can all systems at the study level connect and are they interoperable?
- How will all parties have visibility of the data?
- How will 'missing' data be handled? Biostatistics can be handled differently?
Why involve tech-focused companies now?
Engaging technology, device, and data partners during the study concept phase—often as soon as endpoints are discussed—helps ensure the scientific objectives are feasible and measurable. Early collaboration aligns endpoint design with available and validated technologies, reducing downstream redesign and execution risk. Connecting these partners with sites early also supports smoother adoption and stronger compliance throughout the trial.
What aspects of the study concept should they inform?
| Protocol Element | Stakeholders at the Table |
|---|---|
| Schedule of Events | Sponsor, Site, Tech, Patients |
| Endpoints | Sponsor, Site, Tech, Patients |
| Data Management | Sponsor, Site |
Why involve this group in protocol development?
Involving technology, device, and data partners during protocol development is critical to ensuring operational feasibility and effective execution. Increased engagement with sites and patients during the draft protocol phase supports usability and adoption of required technologies. This stage is also essential for developing change management strategies—such as drug accountability—and vetting feasibility across all stakeholder groups. When a CRO is involved, early and frequent communication becomes even more important to reduce complexity, maintain alignment, and prevent downstream challenges.
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