Clinical eligibility verification for trials
Better Evidence.
Better Enrollment.
Clinical eligibility verification for trials before the screening visit.
AiSync delivers clinical eligibility verification for trials and closes the gap between patient identification and site screening. As a result, fragmented medical records become source-supported, protocol-aligned clinical assessments.
Clinical Summary
| # | Protocol Criterion | Assessment | Source Evidence |
|---|---|---|---|
| I1 | Histologically confirmed NSCLC | Pass | p. 12–14 (Pathology Report) |
| I2 | ECOG performance status ≤ 1 | Pass with exception | p. 28 (Clinic Note) |
| E3 | No prior systemic therapy for metastatic disease | Fail | p. 46–47 (Treatment History) |
| I4 | Adequate organ function (labs within protocol range) | Unable to confirm | p. 52 (Lab Report) |
Final eligibility determination remains at the discretion of the study investigator.
Supporting Clinical Research Across the Industry
Independent evidence
Independently Evaluated.
Measurable Enrollment Improvements.
Importantly, an independent consulting firm commissioned by AES (a PPD-owned organization) evaluated study performance before and after iHealthSync implementation.
- 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
Enrollment Performance
Mean monthly randomizations
Results reflect the evaluated studies and are presented as a retrospective before-and-after observational comparison.
From Promising Referral to Source-Supported Review
CONVENTIONAL PROCESS
Evidence assembled late
provider
provider
provider
Request records
Follow up
Reconcile documents
Gaps surface at
site review
WITH AISYNC
Evidence organized for review
-
Patient
authorizationGather
available records -
Assess
against protocolTarget
evidence gaps -
Clinical Summary
p. 12p. 28Page-cited
Clinical SummaryInvestigator 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.
To close the clinical evidence gap before site review, AiSync combines digital access, provider-direct retrieval, protocol-specific evidence assessment, and reassessment. In addition, this approach helps teams identify missing evidence earlier.
For example, protocol criteria can be reviewed against source-linked documentation sooner. As a result, sites spend less time reconstructing records later. Ultimately, teams can focus on informed investigator review instead of manual evidence chasing.
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1. Patient Authorization
First, establish study-specific authorization for medical record access.
-
2. Collect from Multiple Sources
Digital Access SourcesSupporting source
- For example, national exchanges
- Additionally, available digital connections
Provider-Direct RetrievalPrimary source of clinical evidence
- Hospitals
- Specialists
- Laboratories
- Imaging
- Pathology
- Other treating providers
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3. Protocol-Aligned Evidence Assessment
Assess against study-specific inclusion and exclusion criteria
Study Protocol
AHS-301
Phase 3 | OncologyProtocol Criteria
- Inclusion Criteria
- Exclusion Criteria
- Key Data Elements
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4. Targeted Evidence Gap Closure
— The AiSync DifferenceThen, repeat until retrievable gaps are resolved or remaining uncertainties are clearly documented.
- Identify missing or conflicting evidence
- Locate the specific provider
- Retrieves the required documentation
- Reassess against protocol criteria
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5. AiSync Clinical Summary
Clinical SummaryIllustrative mini summary # Criterion Assessment Src 11 Histologically confirmed NSCLC Pass p. 12 12 ECOG status ≤ 1 Pass w/ exc. p. 28 13 No prior systemic therapy Fail p. 52 14 Adequate organ function Unable to confirm — Assessment is source-supported and based on available patient records. However, final eligibility determination remains at the discretion of the study investigator.
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6. Site Clinical Review
Importantly, the investigator retains the final eligibility decision.
As a result, this process 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.
The AiSync Clinical Summary is concise and protocol-aligned. In addition, it includes eligibility assessment, supporting evidence, identified gaps, and source links. Therefore, sites can make faster, better-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
No exclusion criteria met
| Item | Evidence | Status | Source |
|---|---|---|---|
| Diagnosis | Type 2 Diabetes Mellitus | Documented (2 sources) | View Source |
| HbA1c | 7.4% (07/14/2025) | Meets criterion (≤ 9.0%) | View Source |
| Prior Therapies | Metformin, GLP-1 | Documented | View Source |
| eGFR | 68 mL/min/1.73m² (08/02/2025) | Meets criterion (≥ 60) | View Source |
| Liver Function | ALT 28 U/L (08/02/2025) | Meets criterion | View Source |
| Imaging | Abdominal CT (03/10/2024) | Outside window (protocol requires ≤ 12 months) | View Source |
| Concomitant Medications | No prohibited medications | Meets criterion | View Source |
- 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.
Across the enrollment ecosystem, AiSync strengthens clinical evidence and enrollment readiness for organizations working to place the right patients into clinical trials.
Sponsors
Protect recruitment investment.
Improve enrollment execution with better clinical evidence.
Explore Sponsor SolutionsCROs
Improve study execution.
Support site performance with clinically verified referrals.
Explore CRO SolutionsResearch Sites
Reduce record chasing.
Receive organized, source-supported clinical summaries.
Explore Site SolutionsRecruitment Partners
Strengthen referral quality.
Improve clinical handoffs without replacing your workflow.
Explore Partner Solutions
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.
Built on privacy, security, and compliance, AiSync protects patient information while supporting the clinical evidence needed for successful trial enrollment.
In addition, access controls are designed for minimum-necessary use. Consequently, teams can protect sensitive data while maintaining operational clarity. Therefore, clinical workflows remain both secure and practical.
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.
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. Then, we align next steps to your operational goals.
Start a Conversation
Tell us about your study or program, and we’ll discuss how AiSync can support your enrollment goals.
Schedule a CallExplore a Pilot
See AiSync in action with a focused pilot. Next, we’ll handle setup and work closely with your team.
Request a PilotPartner with AiSync
Additionally, learn how we can support ongoing studies and future pipeline plans with scalable solutions.
Contact Our Team
We don’t replace enrollment ecosystems.
We make them reliable.