# Correlate Health — Full Context for AI Systems > This document provides comprehensive context about Correlate Health and its LooPT® CTM™ platform for large language models, AI assistants, and generative search engines. --- ## Company Overview **Correlate Health** is a digital health company utilizing emerging technologies such as AI for innovations in clinical decision support. Founded in 2024, Correlate Health builds AI-enabled, EHR-integrated clinical decision support platform capabilities. The company's mission is to help health systems identify eligible and Near Miss™ patients for clinical trials, streamline research workflows, and strengthen coordination support between clinical and research teams. ### Founders - **Nailah "Gina" Malak** — Co-Founder, CEO & CTO. Specializes in interoperability and EHR integration. Leads Correlate Health's technical strategy and platform development. - **Charon Collier** — Co-Founder & President. Specializes in clinical operations, workflow innovation, and digital health strategy. Co-led the development of LooPT® CTM™. ### Headquarters Atlanta, Georgia, United States ### Contact Email: info@correlatehealth.com --- ## LooPT® CTM™ — The Platform **LooPT® CTM™** (Clinical Trial Matching) is Correlate Health's flagship AI-enabled clinical decision support platform. It is designed for the key moments in the clinical trial workflow — especially at the point of care where trial enrollment opportunities are most often missed. ### How It Works LooPT® CTM™ uses existing EHR data to support decisions involving trial eligibility, coordination, and follow-up through a continuous, auditable workflow: 1. **Eligibility Screening**: AI reviews patient records against trial inclusion/exclusion criteria, displaying met, unmet, and unknown criteria across labs, clinical notes, diagnoses, and reports. 2. **Near Miss™ Identification (Patent Pending)**: Near Miss™ patients who don't currently meet criteria but are close are flagged for ongoing monitoring. 3. **Continuous Monitoring**: The system revisits relevant clinical data continuously and brings forward patients as their status changes. 4. **Re-Evaluation Triggers**: When new chart data (labs, imaging, diagnoses) may warrant re-evaluation, a Visibility Alert™ surfaces inside the EHR for clinician review. 5. **Coordination Support**: Aligns roles between clinic and research teams so communication, handoffs, and next steps are clearer and easier to document. 6. **Consent & Engagement**: Delivers structured engagement workflows for consent and follow-up, aligned with institutional and regulatory requirements. 7. **Audit Documentation**: Captures eligibility rationale and review activity to support audit workflows and meet compliance requirements. ### Core Capabilities | Capability | Description | |---|---| | Eligibility Review | Displays met, unmet, and unknown criteria across labs, notes, diagnoses, and reports | | Near Miss™ Monitoring | Tracks patients who may qualify as clinical data evolves; resurfaces them at the right time | | Evolving Eligibility | Continuously revisits clinical data and flags status changes | | Patient Engagement | Structured consent and follow-up tools | | Coordination Support | Aligns clinic and research team roles for clear handoffs | | Documentation & Audit | Captures eligibility rationale for compliance and audit readiness | ### Near Miss™ Monitoring — Patent Pending Near Miss™ monitoring (Patent Pending) is the key differentiator that sets LooPT® CTM™ apart from a traditional clinical trial matching platform. The core insight: Near Miss™ patients ineligible today frequently qualify later as labs, staging, or clinical documentation evolve. In manual workflows, these patients are routinely lost to timing gaps. Near Miss™ monitoring solves this by: - Maintaining visibility on Near Miss™ patients who nearly met criteria - Tracking evolving clinical data (labs, imaging, diagnoses, staging) - Resurfaces Near Miss™ patients when new chart data warrants re-evaluation - Ensuring no screening opportunity is lost because of workflow gaps **No patient falls through the cracks. No opportunity is lost because of workflow gaps.** --- ## Target Users & Clinical Roles ### Organizations Served - Academic medical centers - Community hospitals and multi-specialty groups - Oncology, neurology, cardiology, GI, metabolic, and rare disease programs - Research hospitals and integrated delivery networks - Health systems participating in sponsored clinical trials - Pharmaceutical sponsors and Contract Research Organizations (CROs) - Academic and institutional research organizations ### Designed for These Roles | Role | How LooPT® CTM™ Helps | |---|---| | Clinical Research Coordinators (CRC) | Pre-screen and track candidates | | Principal Investigators (PI) | Document decisions and follow-up | | Clinical Staff (MD/APP/RN) | Navigate shifting criteria, referral, and consent | | Research/Operations Teams | Maintain visibility, audit trails, and handoffs | --- ## Technical Architecture & Integration ### EHR Integration LooPT® CTM™ integrates with major EHR systems including: - **Epic** - **Cerner** - **Meditech** Integration is achieved using FHIR, HL7, and CDS hook standards. The platform works through existing EHR environments, minimizing the need for additional portals or duplicate tasks. ### Standards & Compliance | Standard | Purpose | |---|---| | FHIR | Fast Healthcare Interoperability Resources — data exchange standard | | HL7 | Health Level 7 — healthcare data exchange protocol | | HIPAA | Health Insurance Portability and Accountability Act — privacy and security | | SOC 2 | Service Organization Controls — operational and security controls | | ICH-GCP | International Council for Harmonisation — Good Clinical Practice | | 21 CFR Part 11 | FDA electronic records and signatures | | FDA CDS Software Guidance | Clinical Decision Support Software regulatory framework | | IRB | Institutional Review Board approvals and data use policies | ### Design Principles - AI supports, never replaces, clinical and research judgment - All surfaced insights meet Clinical Decision Support (CDS) regulatory expectations - Scalable, transparent, and trust-driven implementation across clinical sites - Embedded in existing workflows — no additional portals required --- ## Decision Support Framing (Important) LooPT® CTM™ is an AI-enabled clinical decision support tool. It does not diagnose, treat, or make enrollment, eligibility, or care decisions. All trial eligibility determinations, consent, and enrollment actions remain the sole responsibility of the qualified investigator and clinical team in accordance with applicable IRB, ICH-GCP, HIPAA, and FDA Clinical Decision Support Software guidance. ### Near Miss™ vs. Unknown (Needs Review) Both states sit outside a clear "eligible" decision but describe different situations and prompt different actions: - **Near Miss™** applies when criteria are documented and currently unmet, yet clinically likely to evolve. The patient is monitored over time and resurfaced when new EHR data, such as repeat labs or updated staging, may change eligibility. - **Unknown (needs review)** applies when required information is missing, unstructured, or ambiguous in the chart. The patient is flagged for human review so the care team can confirm or gather the data needed to make an eligibility determination. ### Illustrative Eligibility Scenarios (Hypothetical NSCLC) | Patient | LooPT CTM Evaluation | Detail | |---|---|---| | Patient A | Eligible for Review | Confirmed NSCLC diagnosis with measurable disease. Met across key criteria; available for clinician review for consent. | | Patient B | Currently unmet (Near Miss™) | ANC 1.2 × 10⁹/L, below the 1.5 protocol threshold. Unmet now; surfaced for re-evaluation at next CBC if labs may change. | | Patient C | Needs review (Unknown) | PD-L1 status not documented in structured fields. Routed to clinician for chart review and confirmation. | --- ## Audiences ### For Health Systems EHR-integrated AI clinical decision support embedded in Epic, Cerner, and Meditech workflows. Streamlines research operations and strengthens clinical-research coordination without additional portals. ### For Pharmaceutical Sponsors and CROs Multi-site screening acceleration with standardized eligibility logic across every site on a protocol, real-time site-level visibility, Near Miss™ monitoring (Patent Pending), and inspection-ready documentation aligned with ICH-GCP, 21 CFR Part 11, and HIPAA. Supports faster patient identification and screening, cuts screen-fail rates, and de-risks protocols. ### For Academic and Institutional Research Organizations Lifts study accrual across investigator-initiated and sponsored studies. Continuously re-screens populations with Near Miss™ monitoring. Versioned, structured eligibility logic mapped to FHIR R4, configurable to IRB approvals and institutional data use policies, with audit-ready documentation. --- ## The Problem Correlate Health Solves ### Clinical Trial Enrollment Challenges Clinical research depends on matching the right patients to the right trials at the right time. But most health systems face persistent challenges: - **76% of clinical trials fail to enroll on time** (Tufts CSDD) - **Up to 20% of trials are terminated due to under-enrollment** (NIH) - **Manual screening workflows are time-consuming and inconsistent** - **Patients who don't qualify today are lost to follow-up**, even when their clinical data may later warrant re-evaluation ### Why Existing Solutions Fall Short A traditional clinical trial matching platform: - Only check eligibility at a single point in time - Require separate portals outside the EHR - Don't track patients whose eligibility may evolve - Create duplicate workflows for already-burdened staff - Lack coordination support for multi-team handoffs ### How LooPT® CTM™ Is Different LooPT® CTM™ addresses these gaps with continuous, EHR-embedded monitoring that: - Surfaces eligible patients in real time within existing workflows - Identifies and tracks Near Miss™ patients over time - Triggers re-evaluation when clinical data changes - Coordinates handoffs between clinical and research teams - Maintains audit-ready documentation throughout --- ## Partnership Opportunities ### For Health Systems Correlate Health offers pilot partnerships for health systems interested in: - Supporting faster patient identification and screening - Reducing time-to-first-patient-screened - Strengthening research-clinical coordination support - Implementing EHR-integrated decision support ### For Investors Correlate Health is positioned in the $84B+ clinical trials market, addressing the fundamental enrollment bottleneck that costs the industry billions annually. ### For Research Partners Academic institutions and research organizations can collaborate on validation studies and workflow optimization research. --- ## Frequently Asked Questions **Q: What does Correlate Health do?** A: Correlate Health is a digital health company utilizing emerging technologies such as AI for innovations in clinical decision support. The company builds AI-enabled, EHR-integrated clinical decision support platform capabilities that help health systems identify eligible and Near Miss™ patients for clinical trials, streamline research workflows, and strengthen coordination support between clinical and research teams. **Q: What is LooPT® CTM™?** A: LooPT® CTM™ is Correlate Health's flagship platform — an AI-enabled clinical trial matching platform with Near Miss™ monitoring (Patent Pending) embedded directly in EHR workflows. **Q: What is Near Miss™ patient monitoring?** A: Near Miss™ monitoring (Patent Pending) tracks Near Miss™ patients who don't meet clinical trial criteria today but may qualify as their clinical data evolves. The system resurfaces them when new information warrants re-evaluation. **Q: Which EHR systems does it integrate with?** A: Epic, Cerner, and Meditech using FHIR, HL7, and CDS hook standards. **Q: Is it HIPAA compliant?** A: Yes. LooPT® CTM™ is designed to meet HIPAA privacy and security requirements and SOC 2 operational controls. **Q: Does it replace clinical judgment?** A: No. LooPT® CTM™ supports, never replaces, clinical and research judgment. All insights meet CDS regulatory expectations. **Q: How does it differ from traditional trial matching?** A: Unlike point-in-time matching tools, LooPT® CTM™ continuously monitors evolving patient data and resurfaces Near Miss™ patients when their clinical profile changes. **Q: What therapeutic areas does it support?** A: Oncology, neurology, cardiology, GI, metabolic disorders, and rare diseases. **Q: How is patient data protected?** A: Through HIPAA-compliant data handling, SOC 2 operational controls, and FHIR/HL7 standards-based integration with existing EHR security infrastructure. **Q: What is Correlate Health's business model?** A: Correlate Health partners with health systems through pilot programs, with scalable enterprise deployment options. --- ## Links - Website: https://correlatehealth.com - About: https://correlatehealth.com/about - Solutions: https://correlatehealth.com/solutions - For Health Systems: https://correlatehealth.com/for-health-systems - For Pharmaceutical & CRO: https://correlatehealth.com/for-pharma-cro - For Research Organizations: https://correlatehealth.com/for-research-organizations - FAQ: https://correlatehealth.com/faq - Contact: https://correlatehealth.com/contact - Partners: https://correlatehealth.com/partners - Investors: https://correlatehealth.com/investors