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AiSync | Clinical Eligibility Verification & Enrollment Readiness

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.

p. 52Lab Report
p. 12Pathology
p. 28Clinic Note
Clinical Summary Patient ID AHS-1048927
De-identified · Age 54 · Female
Protocol Criteria Source Documents Timeline Summary

ProtocolAHS-301Phase 3 · Oncology

IndicationNon-Small Cell Lung Cancer (NSCLC)

Assessment Status8 of 10Criteria Assessed

#Protocol CriterionAssessmentSource Evidence
I1Histologically confirmed NSCLCPASSp. 12–14 (Pathology Report)
I2ECOG performance status ≤ 1PASS WITH EXCEPTIONp. 28 (Clinic Note)
E3No prior systemic therapy for metastatic diseaseFAILp. 46–47 (Treatment History)
I4Adequate organ function (labs within protocol range)UNABLE TO CONFIRMp. 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

Supporting Clinical Research Across The Industry

Alto NeuroScience Trialbee Syneos Health Parexel Pfizer Eli Lilly AbbVie Roche Genentech Regeneron Ferring Axsome Myovant Kiniksa Ironwood Verona Pharma Praxis Precision Medicines Medpace

Supporting 300+ clinical studies across 70+ indications since 2017.

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.

52,386patients
1,672research sites
9clinical studies
29 monthsanalysis period
200%+randomization improvement
130%+consent improvement
18:1 → 3:1screen-fail ratio improvement
p = 0.001reported statistical significance
Results reflect the evaluated studies and are presented as a retrospective before-and-after observational comparison.

The clinical evidence gap

Finding Patients Is Only the Beginning.

Many promising referrals stall due to incomplete or inaccessible clinical evidence. AiSync helps sites organize, assess, and act on source-supported evidence earlier in the process.

Traditional Referral Process

Disjointed. Time-consuming. Uncertain.

Patient-reported diagnosis

Questionnaire prescreening

Fragmented records across providers

Missing or conflicting clinical evidence

Site chases documentation

Late discovery of exclusions

With AiSync

Organized evidence. Greater efficiency. Clearer insights.

Source-supported diagnosis evidence

Protocol-specific clinical assessment

Aggregated longitudinal documentation

Targeted evidence-gap resolution

AiSync Clinical Summary p. 12p. 28p. 52 Page-cited Clinical Summary

Earlier visibility into eligibility risks

More referrals do not automatically mean more enrollments.Better clinical evidence creates a more efficient path forward.

AiSync helps organize and assess documented evidence to support study feasibility and eligibility review. The site investigator retains the final eligibility decision.

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.

01

Step 1

Patient Authorization

Study-specific authorization for medical record access.

  • Signed before any chart is retrieved
  • Scoped to this protocol only
  • Limited to minimum-necessary records
02

Step 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
03

Step 3

Protocol-Aligned Evidence Assessment

Assess against study-specific inclusion and exclusion criteria.

Study ProtocolAHS-301Phase 3 | Oncology
  • Inclusion Criteria
  • Exclusion Criteria
  • Key Data Elements
04

Step 4

Targeted Evidence Gap Closure

The AiSync Difference

Identify missing or conflicting evidence
Locate the specific provider

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

Retrieve the required documentation
Reassess against protocol criteria
05

Step 5

AiSync Patient ID: AHS-1048927
De-identified

AiSync Clinical Summary

  • I1Histologically confirmed NSCLCPASSp. 12
  • I2ECOG performance status ≤ 1PASS WITH EXCEPTIONp. 28
  • E1No prior systemic therapy for metastatic diseaseFAILp. 52
  • I4Adequate organ function within protocol rangeUNABLE TO CONFIRM—

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

06

Step 6

Site Clinical Review

The investigator retains the final eligibility decision.

  • PASS
  • EXCEPTION
  • FAIL

The summary informs the review. The site makes the call.

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

Radiology ReportPage 12
Laboratory Report

HbA1c
7.4%

Page 3
Progress Note

Type 2 diabetes mellitus

Metformin 1000 mg BID
(GLP-1 agent)

Page 5

Clinical Summary

Study ABC-123  |  Patient ID: 10475  |  Summary Date: Oct 15, 2026

PASSMeets 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

DiagnosisType 2 Diabetes MellitusDocumented (2 sources)View Source
HbA1c7.4% (02/14/2025)Meets criterion (≤ 9.0%)View Source
Prior TherapiesMetformin, GLP-1DocumentedView Source
eGFR68 mL/min/1.73m² (01/02/2025)Meets criterion (≥ 60)View Source
Liver functionALT 28 U/L (08/02/2025)Meets criterionView Source
ImagingAbnormal CT (03/10/2024)Out of window (protocol requires ≤ 12 months)View Source
Concomitant MedicationsNo prohibited medicationsMeets criterionView Source
Source-linked evidence7 criteria · pages cited

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 →
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