Tech, Device, and Data Co : Study Concept

Trial Design Stage

Published Date: April 29, 2025

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Helpful Terms and Definitions

ClinicalTrials.gov Glossary Terms

NIH Glossary of Common Terms

FDA Drug Development and Review Definitions

Resources*

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*This list is not exhaustive, nor does CTTI officially endorse the resources created by other organizations.

Study Concept

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

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?

Tech, Device, and Data Company Resources

Strategic Frameworks & Digital Evolution

These resources provide the "big picture" rationale for digital transformation and hybrid model adoption.

- PwC/AWS: A Smarter Approach to Clinical Trial Design & Delivery: Strategic overview of how cloud infrastructure and data analytics enable more agile trial delivery.
- Hybrid Trial Design: How, When, & Why: Foundational guide for operational leaders on blending site-based and remote participation models.
- Digital Health Technologies in Clinical Trials (ScienceDirect): Academic perspective on the shifting landscape of trial design as digital tools become primary data-gathering assets.

Operational Implementation & Site Engagement

Tactical resources for deploying technologies at the site level and managing wearable integration.

- Engaging Sites with Technology (Life Science Leader): Practical insights on minimizing site burden and ensuring technology adoption at the investigative site level.
- Best Practices for Wearable Integration (Ametris): Technical and operational best practices for managing data flows from wearable devices in a clinical environment.
- Digital Decentralized Trials: Participant/Site Perspectives (PMC8734581): Research-based findings on the hurdles and successes of decentralized clinical trials (DCTs) from the viewpoint of key collaborators.

Regulatory & Technical Standards

Essential requirements for ensuring digital data integrity and novel endpoint acceptance.

- FDA Guidance: Digital Health Technologies (DHTs) for Remote Data Acquisition: The core FDA regulatory framework for utilizing DHTs to collect data remotely in clinical investigations.
- CTTI: Digital Health Trials Project: The primary CTTI repository for evidence-based recommendations regarding the use of DHTs.
- CTTI: Novel Endpoint Acceptance Recommendations: Crucial technical guidance for sponsors seeking to use digitally-derived data as primary or secondary endpoints in formal submissions.