Clinical eligibility verification for clinical trials

Better Evidence.
Better Enrollment.

Clinical eligibility verification before the screening visit.

AiSync bridges the gap between patient identification and site screening, transforming fragmented medical records into source-supported, protocol-aligned clinical assessments.

Reduce screening inefficiencies. Give coordinators time back. Improve enrollment execution.

Patient ID AHS-1048527
De-identified | Age 54 | Female
ProtocolAHS-301Phase 3 | Oncology
IndicationNon-Small Cell Lung Cancer (NSCLC)
Assessment Status8 of 10Criteria Assessed
Illustrative protocol criteria with documentation status and source evidence
#Protocol CriterionAssessmentSource Evidence
I1Histologically confirmed NSCLCPass p. 12–14 (Pathology Report)
I2ECOG performance status ≤ 1Pass with exception p. 28 (Clinic Note)
E3No prior systemic therapy
for metastatic disease
Fail p. 46–47 (Treatment History)
I4Adequate organ function
(labs within protocol range)
Unable to confirm p. 52 (Lab Report)
Assessment is source-supported and based on available patient records.
Final eligibility determination remains at the discretion of the study investigator.
10 source documents reviewed
Illustrative AiSync Clinical Summary showing four documentation statuses with page-cited sources. Synthetic demonstration; not patient data.

Supporting Clinical Research Across the Industry

  • Alto NeuroScience
  • Trialbee
  • Syneos Health
  • Parexel
  • Pfizer
  • Eli Lilly
  • AbbVie
  • GlaxoSmithKline
  • Roche
  • Satsuma Pharmaceuticals
  • Genentech
  • Ferring
  • Axsome
  • Myovant
  • Kiniksa
  • Ironwood
  • Regeneron
  • Verona Pharma

Independent evidence

Independently Evaluated.
Measurable Enrollment Improvements.

An independent third-party analysis conducted by a consulting firm commissioned by AES, a PPD-owned organization, evaluated study performance before and after implementation of iHealthSync services.

Independent Third-Party Analysis iHealthSync was unaware the evaluation was underway and did not participate in the analysis.
  • 52,386
    patients
  • 1,672
    research sites
  • 9
    clinical studies
  • 29 months
    analysis period
  • 200%+
    randomization improvement
  • 130%+
    consent improvement
  • 18:1 → 3:1
    screen-fail ratio improvement
  • p = 0.001
    reported statistical significance

Enrollment Performance

Mean monthly randomizations

200%+
Improvement
200%+
mean monthly randomization increase across evaluated studies
Enrollment Performance chart. Mean monthly randomizations rose from 12 before iHealthSync to 36 after iHealthSync, a 200%+ improvement.

Results reflect the evaluated studies and are presented as a retrospective before-and-after observational comparison.

From Promising Referral to Source-Supported Review

Promising referral reaches the study team

CONVENTIONAL PROCESS

Evidence assembled late

Provider A
Provider B
Provider C

Request records

Reconcile documents

Gaps surface at
site review

WITH AISYNC

Evidence organized for review

  1. Patient
    authorization

    Gather
    available records

  2. Assess
    against protocol

    Target
    evidence gaps

  3. Clinical Summary

    p. 12
    p. 28

    Page-cited
    Clinical Summary

    Investigator makes
    final eligibility
    decision

Better evidence at the clinical handoff. Clearer review for the investigator.

The AiSync closed-loop evidence engine

We Don’t Stop at the Records We Find.
We Pursue the Evidence the Protocol Requires.

AiSync combines digital access, provider-direct retrieval, protocol-specific evidence assessment, and reassessment to close the clinical evidence gap before site review.

  1. 1. Patient Authorization

    Study-specific authorization for medical record access.

  2. 2. Collect from Multiple Sources

    Digital Access Sources

    Supporting source

    • National Exchanges
    • Available digital connections
    Provider-Direct Retrieval

    Primary source of clinical evidence

    • Hospitals
    • Specialists
    • Laboratories
    • Imaging
    • Pathology
    • Other treating providers
  3. 3. Protocol-Aligned Evidence Assessment

    Assess against study-specific inclusion and exclusion criteria

    Study Protocol
    AHS-301
    Phase 3 | Oncology

    Protocol Criteria

    • Inclusion Criteria
    • Exclusion Criteria
    • Key Data Elements
  4. 4. Targeted Evidence Gap Closure
    — The AiSync Difference

    Repeat until retrievable gaps are resolved or remaining uncertainties are clearly documented.

    1. Identify missing or conflicting evidence
    2. Locate the specific provider
    3. Retrieves the required documentation
    4. Reassess against protocol criteria
  5. 5. AiSync Clinical Summary

    AiSyncClinical Summary
    Patient ID AHS-1048527 · De-identified · Age 54
    Illustrative mini summary
    #CriterionAssessmentSrc
    11Histologically confirmed NSCLCPassp. 12
    12ECOG status ≤ 1Pass w/ exc.p. 28
    13No prior systemic therapyFailp. 52
    14Adequate organ functionUnable to confirm—

    Assessment is source-supported and based on available patient records. Final eligibility determination remains at the discretion of the study investigator.

  6. 6. Site Clinical Review

    The investigator retains the final eligibility decision.

AiSync closes the clinical evidence gap through targeted retrieval and reassessment — not just record collection.

The AiSync Clinical Summary

A Clear, Source-Supported
View of Eligibility.

AiSync delivers a concise, protocol-aligned Clinical Summary with a clear eligibility assessment, supporting evidence, identified gaps, and direct links to the source documentation — so research sites can make faster, more informed decisions.

  • Pass

    Meets all inclusion and no exclusion criteria

  • !Pass with exception

    Meets criteria with protocol-specific exception(s)

  • Fail

    Does not meet inclusion and/or meets an exclusion criterion

Clinical Summary
Study ABC-123  |  Patient ID: 10473  |  Summary Date: Oct 15, 2026
PASS
Meets inclusion criteria
No exclusion criteria met
Eligibility Criteria Overview
Inclusion Criteria8 of 8 met
Exclusion Criteria0 of 6 met
Requires Further Assessment0
Key Clinical Evidence
Illustrative key clinical evidence
ItemEvidenceStatusSource
DiagnosisType 2 Diabetes Mellitus Documented (2 sources)View Source
HbA1c7.4% (07/14/2025) Meets criterion (≤ 9.0%)View Source
Prior TherapiesMetformin, GLP-1 DocumentedView Source
eGFR68 mL/min/1.73m² (08/02/2025) Meets criterion (≥ 60)View Source
Liver FunctionALT 28 U/L (08/02/2025) Meets criterionView Source
ImagingAbdominal CT (03/10/2024) Outside window (protocol requires ≤ 12 months)View Source
Concomitant MedicationsNo prohibited medications Meets criterionView Source
Illustrative AiSync Clinical Summary for a synthetic patient. Not patient data.
  • Clear eligibility outcome

    PASS / EXCEPTION / FAIL

  • Protocol-aligned criteria review

    Inclusion, exclusion, and open items

  • Direct source links

    Jump to the exact page in the record

  • Identified gaps

    With next steps when applicable

  • Concise and Actionable

    Key findings in a format built for research sites.

  • Source-Paged Evidence

    Direct links to the exact record documentation.

  • Protocol-Aligned

    Focused on study-specific inclusion and exclusion criteria.

  • Minimum-Necessary

    Only the relevant information needed for eligibility review.

Built for the entire enrollment ecosystem

One Solution.
Four Distinct Advantages.

AiSync strengthens clinical evidence and enrollment readiness for every organization involved in getting the right patients into clinical trials.

We don’t replace enrollment ecosystems. We make them reliable.

Records are the input. Clinically verified eligibility is the outcome.

Security, privacy & compliance

Built for Trust.
Designed for Clinical Research.

AiSync is built with privacy, security, and compliance at its core — protecting patient information while enabling the clinical evidence needed for successful trial enrollment.

  • Patient Authorization First

    Study-specific HIPAA authorization for every patient. We only access and retrieve records with explicit patient consent.

  • Secure Data Handling

    Encrypted data in transit and at rest, with role-based access controls and comprehensive audit logging.

  • Minimum Necessary Data

    We deliver only the information needed for protocol eligibility, in accordance with 45 CFR §164.502(b).

  • Enterprise-Grade Security

    Built on industry-leading infrastructure with continuous monitoring, regular testing, and strict data governance.

Your Patients. Our Responsibility.

We combine rigorous privacy and security standards with a deep understanding of clinical research requirements — so you can move forward with confidence.

Learn More About Our Security

Let’s bring clinically verified patients to your study

Ready to See
What AiSync Can Do for You?

Whether you’re a sponsor, CRO, research site, or recruitment partner, we’ll work with you to scope the right approach for your study or network.

  • Start a Conversation

    Tell us about your study or program and we’ll discuss how AiSync can support your enrollment goals.

    Schedule a Call
  • Explore a Pilot

    See AiSync in action with a focused pilot. We’ll handle the setup and work closely with your team.

    Request a Pilot
  • Partner with AiSync

    Learn how we can support your ongoing studies and future pipeline with scalable solutions.

    Contact Our Team

We don’t replace enrollment ecosystems.
We make them reliable.

Get Started Today
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