Empowering MedTech with Streamlined, Fit-For-Purpose Clinical Research Analytics

Optimize your total product lifecycle with less cost, time, and risk

3Aware Capabilities

3Aware provides a proprietary, AI-driven Clinical Scientific Workbench powered by real-world data from deep, federated health system integrations across a collaborative research network. This approach strengthens investigator-led research within partner institutions while enabling MedTech manufacturers to remotely run in silico, non-interventional observational studies on their products as used at the point of care. 3Aware's Clinical Scientific Workbench leverages comprehensive longitudinal patient records - structured and unstructured data - where researchers can rapidly define relevant cohorts, preserve full chronological and episode-of-care context, and use interpretive AI to efficiently surface and intuitively understand the determinant signals and insights embedded across each patient's longitudinal medical record; unlocking actionable insights that improve device safety, performance, and patient outcomes.

3Aware vs. Traditional Methods

Compared to traditional RWE methods, 3Aware reduces time, risk and resources dependency, thus accelerating study timelines… and ongoing access to pre-identified, device-specific cohorts is available for ad hoc studies. Both data bias and operational risk are significantly decreased because the study cohort is immediately known and described via a feasibility assessment, before committing to the full study.

3Aware Clarity

Device & Patient Insights

3Aware pinpoints specific devices and device categories to specific patient events via UDI numbers, integrated from a variety of health system data sources. Comprehensive longitudinal data, including Patient Reported Outcome Measures (PROMs), EHR imaging and procedure-specific clinical evidence, is available for a multitude of compliance and portfolio optimization uses… for example, tracking Class III implants.

Scientific Workbench

The AI-powered scientific work bench employs Reinforced Learning from Human Feedback, Natural Language Processing & Understanding (NLP/U) and soon: End-Point Specific LLMs, to streamline the analysis of complex data, maximizing real-time clinical insights and regulatory readiness. Patient level findings are provided, as well as clear summaries, to facilitate report generation.

Governance

3Aware ensures rigorous standards to protect data integrity and patient health information. Our platform is built on a HITRUST® Risk-based, 2-year certified platform that employs robust cybersecurity measures, including continuous vulnerability scanning and annual third-party audits, which have consistently shown no vulnerabilities. All data is de-identified according to stringent expert determination standards and encrypted in transmission and at rest, ensuring data privacy. Additionally, access to client information is strictly controlled, with a least privilege and need-to-know policy enforced alongside a thorough quality assurance process to maintain data integrity and reliability.

"Of the data options available, 3Aware is the first and only platform I know of that connects specific devices to patient medical records and offers users direct access to de-identified patient-level data, including unstructured clinical notes."

Scott Snyder, PhD

Sr. Director of Statistics & Data Science
Cook Research Incorporated

3Aware Coverage

3Aware has coverage of over 60K devices, sourced from a patient population of over 20M, and growing. Data is integrated from electronic health records and a myriad of administrative, operational, accounting/billing, supply chain management and operating room scheduling systems. A specific device is connected to a specific patient by connecting data points via their various unique identifiers.

3Aware Engagement Model

Identify Devices
By UDI, Version/Model Number or
Catalog Number
1
2
First Cut
Pinpoint Population(s) of Interest
Minimize Selection
Intake Process
Collaborative Interview to Identify Outcomes,
Data Elements & Required Follow-Up
3
4
Feasibility Assessment
Access Sample: ≥10% of Full Cohort
De-Risk Full Project
Full Project
Sandbox Environment
Scientific Support
5
6
Ongoing Clinical Partnership
Subscription Ensures Ongoing Access
Repeatable Projects
Continuing Surveillance
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