Our Work
Health Evidence Analytics LLC (H.E.A.L.) builds nationwide clinical research networks accelerating evidence generation for medical innovations. Partnering with FDA leadership and Med-Tech executives, we deploy innovative clinical trial tools and real-world data systems meeting regulatory-grade evidence and advancing clinical care. Leveraging AI/ML expertise, H.E.A.L. develops clinical decision support (CDS) and Software as a Medical Device (SaMD) solutions leveraging evolving evidence and regulatory standards. Our hospital executive and care team partnerships drive healthcare quality adherence programs, economic registries, and point-of-care improvements, such as guideline-driven care protocols implementing robust clinical data. Aligning these diverse stakeholder teams, we implement evidence-based tools improving patient outcomes while supporting value-based care initiatives.
Clinical Evidence Networks
Scenario 1: Sponsors, Sites, Regulators and Payers voicing shared opportunities to remove administrative blockers in clinical research to incentivize med-tech innovation.
Research Network Solution: Instituted a nation-wide Early Feasibility Study (EFS) network optimizing clinical study operations.
Scenario 2: Struggling with representative patient enrollments, H.E.A.L. helped clients overcome multiple enrollment barriers.
Recruitment/Referral Solution: H.E.A.L. analyzed enrollment barriers to uncover insights overlooked by traditional recruitment efforts. While each project requires a tailored solution, the H.E.A.L. team has resolved recruitment/referral barriers related to point of entry (e.g., ER/ED recruitment, referral process), patient population (pediatrics, mental status, etc.) and patient perception.
Adherence & Outcomes
Scenario: The client’s post-market, real-world evidence (RWE) projects had missed key return-on-investment (ROI) metrics reflecting benefits seen in internal economic and outcome data.
Therapy Adherence Solution: Understanding differences between clinical trial and clinical practice patient journeys, the H.E.A.L. team identified and implemented Direct-to-Patient adherence programs:
Ensuring patient therapy adherence as prescribed, and
Removing barriers to compliance, as identified by patients
Evidence-Based CDS
Scenario: To address existing care gaps between (A) disease incidence/prevalence, and (B) referrals for interventional assessment, the client engaged H.E.A.L. to support evidence-based Clinical Guideline adherence.
Clinical Guideline Solution: Researching current literature and identifying an average 15-to-20-year time lag before evidence-based guidelines are fully integrated into clinical care, H.E.A.L. partnered with healthcare professionals (HCPs) and care organizations to deploy Clinical Guideline tools reengaging patients into recommended care workflows.