Multi-Site vs. Single-Site, Multiple-Location Clinical Studies: FDA Considerations for Cuffless Blood Pressure Devices

Blog Team
6 days ago
2 min read

When planning a clinical research study intended to support an FDA submission, sponsors often encounter terms such as multi-site, multi-investigator, and single-site, multiple-location. While these models may appear operationally similar, they differ in oversight structure, execution, and how evidence is evaluated by the FDA—particularly for cuffless blood pressure devices.

Understanding these distinctions is essential for aligning trial design with FDA expectations and with the validation pathways outlined in the upcoming ISO 81060-7 standard. Importantly, these study model requirements are not applicable to CE mark clearance, where alternative validation strategies may be acceptable.

Multi-Site, Multi-Investigator Studies (FDA Context)

Definition: A multi-site study is conducted at two or more independent clinical sites, each overseen by its own principal investigator (PI). Data from all sites are combined into a single dataset for FDA review.

Key Characteristics

Independent Oversight: Each site PI is responsible for informed consent, protocol compliance, participant safety, and data integrity.
IRB Review: Studies may utilize a central Independent Review Board (IRB) or site-specific IRBs, depending on institutional and sponsor requirements.
Data Management: Variability across sites must be carefully managed through monitoring, training, and protocol controls.

Advantages for FDA Submissions

Demonstrates device performance across independent environments
Supports FDA confidence in protocol execution and data robustness for higher-risk claims

Challenges

Increased operational complexity
Greater need for CRO protocol optimization, CRO risk mitigation, and oversight consistency

Single-Site, Multiple-Location Studies (FDA Context)

Definition: A single-site, multiple-location study is conducted under the authority of one PI and one IRB, with data collected at multiple physical locations that function as extensions of a single study site.

Key Characteristics

Centralized Oversight: One PI maintains direct control over training, protocol execution, and data review across all locations.
IRB Approval: A single IRB typically covers all locations, simplifying regulatory oversight.
Data Consistency: Standardized staff training, procedures, and equipment support controlled execution.

Advantages for FDA-Focused Studies

Strong protocol alignment across locations
Reduced execution variability while still meeting FDA expectations
Streamlined monitoring and documentation for submission readiness

CE Mark Considerations

Multi-site or single-site, multiple-location study designs are not currently mandated for CE mark clearance. CE submissions may allow alternative study designs depending on device classification, claims, and applicable conformity assessment routes.

Sponsors pursuing parallel FDA and CE strategies should carefully evaluate whether study designs optimized for FDA review may exceed CE requirements but still offer strategic value through stronger datasets.

PRL’s Role in Study Execution

Parameters Research Laboratory (PRL) supports FDA submissions with an emphasis on regulatory-grade outcomes.

Single-Site, Multiple-Location Studies: PRL deploys highly-trained and dedicated clinical teams across locations while maintaining centralized oversight aligned with ISO 81060-7 expectations.
Multi-Site Studies: PRL contributes protocol harmonization, CRO risk mitigation, and specialized study teams to support FDA-aligned datasets.

Conclusion

For cuffless blood pressure devices, FDA submissions may need to be supported by either a multi-site or single-site, multiple-location study model in accordance with the upcoming ISO 81060-7. These requirements are specific to FDA pathways and are not required for CE mark clearance.

Selecting the appropriate model—and executing it with precision—directly influences FDA confidence in your data. PRL partners with sponsors and CROs to design and execute FDA-focused clinical studies that deliver regulator-ready clinical evidence. Contact PRL to discuss your study execution strategy.