3Aware Introduces Prospective Studies to Enrich Real-World Evidence for MedTech

December 29, 2025 - 3Aware today announced the availability of Prospective Studies within their offerings, a capability that enables medical device manufacturers to conduct highly efficient prospective studies with world-leading academic health systems within the 3Aware Data Alliance Network.

The 3Aware Data Alliance Network comprises world-leading academic health systems where the 3Aware platform is integrated directly within partners’ IT and data infrastructure. This integration enables highly efficient aggregation, curation, and analysis of prospective data alongside longitudinal retrospective patient records, and facilitates collaboration with key opinion leaders (KOLs) at those sites.

Now, in addition to retrospectively accessing complete longitudinal electronic health records for device-specific patient cohorts on demand, manufacturers can prospectively harvest incremental, nuanced data that is not typically captured in the normal course of care delivery—such as imaging context, patient-reported outcome measures (PROMs), and device- or procedure-specific details. This applies both to existing on-market products and newly launched products that may not yet have a rich retrospective history.

“The real value here isn’t just capturing incremental data—it’s what happens after the data flows directly into our analytics platform,” said William (Bill) Moss, CEO of 3Aware. “By unifying the EHR and incremental data in one environment, we enable clinical scientists to work at the top of their license, using automated, AI-assisted workflows to define cohorts, compare devices, and surface outcomes efficiently across the entire product lifecycle.”

“By co-designing prospective capture with our Data Alliance Network partners and streaming that incremental detail directly into the 3Aware platform, these prospective studies give teams a single, transparent environment to answer questions from R&D to first approvals, PMCF and beyond,” said Amelia Hufford, PhD, SVP, Clinical & Regulatory Science Operations at 3Aware.

What's New

• Question-first, lifecycle-ready design
  Begin with clear objectives—PMCF, label expansion, payer evidence, or R&D—and translate them into required data elements, endpoints, and study designs that work across both pre-market and post-market phases.
• Prospective capture of missing elements in routine care
  Prospectively capture high-value elements that are often absent or incomplete in standard EHRs—such as radiology reports/images, PROMs, and device/procedure fields—aligned to predefined endpoints, not just generic retrospective requirements.
• 3Aware’s full longitudinal context, leveraged for prospective studies
  Build cohorts at the device level (UDI/model/catalog) and link them to comprehensive longitudinal EHR data (structured and unstructured), including comorbidities, medications, procedures, and clinician notes.
• Integrated with the 3Aware Data Alliance Network
  Leverage world-leading academic health systems where the 3Aware platform is embedded in partners’ IT/data infrastructure, enabling highly efficient aggregation, curation, and analysis of prospective incremental data alongside complete retrospective patient histories.
• Unified analytics and auditability in one platform
  Use the 3Aware platform to stratify subgroups(e.g., age, comorbidities, indication), define comparator arms, track outcomes over time, and maintain reproducible, audit-ready workflows that support regulatory and payer review.
• Low-burden workflows for clinical partners
  Engage clinical KOLs during study design, and design incremental data capture into everyday clinical workflows at Data Alliance Network partner sites, with clear governance and quality controls. Therefore, clinicians can contribute to high-value evidence generation without the overhead of traditional site-based studies.

How It Works

Client Engagement & Intake
3Aware clinical scientists work with manufacturers to translate objectives (e.g., PMCF, label expansion, payer evidence, next-generation R&D) into required data elements and endpoints, and to align on devices, indications, and study design.

Needs Analysis
Using the 3Aware platform’s retrospective capabilities, the team maps which elements are already observable in complete longitudinal EHR-derived data for device-specific cohorts, and which must be captured in addition to the EHR data—defining incremental elements, feasibility, and success criteria.

Clinical Partner Enablement
Within the 3Aware Data Alliance Network, 3Aware collaborates with clinical partners and key opinion leaders to configure low-friction capture of incremental data elements in standard workflows, confirming governance, quality review processes, and data refresh cadence at each academic health system.

Setup & Execution
Incremental data flows into the 3Aware platform alongside traditional longitudinal EHR data via the integrated partner IT/data infrastructure. Sponsors or CROs conduct the study in an analytic environment, supporting cohort definition, comparative analyses, documentation, and export.

Post-Approval Continuity
Upon completion, devices and cohorts transition seamlessly into ongoing post-market evidence generation (e.g., PMCF, safety surveillance, real-world performance monitoring), preserving definitions, cohorts, and workflows rather than starting from scratch.

Where It Helps

• Pre-Market & OUS Access
  Purpose-built evidence to support submissions and evidence generation requirements, including high-risk and innovative devices that need more than retrospective data alone.
• Label Expansion & Market Claims
  Stratified outcomes by indication, demographics, and procedure codes, with visibility into real-world use patterns that can support label updates and marketing assertions.
• PMCF & Surveillance
  Reliable, longitudinal evidence tied to specific devices and endpoints, enabling lighter, more focused PMCF and ongoing post-approval monitoring.
• R&D & Next-Generation Design
  Faster feedback loops for engineering and clinical teams, with imaging context, PROMs, and clinician-observed outcomes informing next-gen design decisions.

Availability

Prospective Studies are now available as part of the 3Aware platform and the 3Aware Data Alliance Network. To request a demo or discuss use cases, contact us here.