Clinical research operations · Aspirox TrialBridge

Clinical research recruitment, connected from protocol to site.

Turn complex eligibility criteria and fragmented research workflows into structured cohort discovery, coordinated screening, and clearer recruitment operations.

Candidate discovery supports human review. It doesn’t make eligibility decisions — qualified people approve every criterion and decide every screening outcome.

In development · previews use synthetic data only

Synthetic workspace
  1. Protocol
  2. Criteria
  3. Cohort
  4. Screening
  5. Sites

Criteria · v1.1

3 proposed
  • I1Age 40–75 years at screening
  • I3eGFR 30–59 mL/min/1.73 m², most recent ≤ 90 days
  • I4HbA1c 7.0–10.5 %, most recent ≤ 90 days
  • E2History of chronic dialysis or kidney transplant
  • E3NYHA class IV heart failure

12 criteria · 9 data-checkable · 3 screener-assessed

Cohort run COH-0007

DS-A · 2,400 records

95 potential matches

All checkable criteria met
38
With data gaps (Unknown)
57

Not eligibility decisions — each goes to human screening.

Screening

  • Awaiting Review54
  • More Information Required10
  • Potentially Eligible6
  • Investigator Review11
  • Not Eligible14

Sites

assigned · awaiting
  • SITE-0138 · 18
  • SITE-0233 · 21
  • SITE-0324 · 15
CND-0042SITE-02◌ E3 NYHA class unknownAwaiting Review

Illustrative preview · fictional trials, sites and candidates · computed from synthetic records

Recruitment slows in the gaps between documents, data and people.

  1. 01

    Eligibility criteria are buried in complex protocol documents.

    Inclusion and exclusion criteria are spread across a synopsis and section 5, mix data-checkable rules with judgement, and change with each amendment.

    §5.1(e) “stable dose of glucose-lowering therapy”

  2. 02

    Relevant information sits in several authorised data sources.

    Diagnoses, lab values and medications arrive in different code systems, units and date conventions. A missing value is easy to mistake for a “no”.

    HbA1c 8.2 % ≈ 66 mmol/mol

  3. 03

    Screening decisions need coordination and review.

    Candidate lists travel between central offices, sites and investigators by email and spreadsheet, so statuses diverge and reasons go unrecorded.

    status: “see email thread”

  4. 04

    Bottlenecks are hard to see across multiple sites.

    A growing backlog at one site, or a criterion that excludes far more people than expected, often surfaces in a monthly report rather than the week it starts.

    SITE-03 · last activity 9 d ago

Five stages. One record of how each candidate got there.

Select a stage to see what you do, what TrialBridge does, and what it hands to the next stage.

Stage 1 of 5 · Research operations manager

Protocol

Keep the protocol and its amendments as the single source of truth for eligibility.

Key action
Upload the protocol PDF or DOCX. TrialBridge extracts the text with page and section anchors.
Output
Protocol v1.1 · 24 pages · eligibility sections located
Leads to Criteria
The located inclusion and exclusion passages become the input for structured criteria.

Output examples come from the synthetic trial SYN-CKD-201.

Every criterion cites the sentence it came from.

TrialBridge proposes structured criteria from a protocol’s eligibility sections. Each proposal links to its source passage, and nothing is used for cohort discovery until a qualified reviewer approves the version.

SYN-CKD-201 · Protocol v1.1Synthetic document
§5.1(a) · p.18

Participants must be between 40 and 75 years of age, inclusive, at the time of screening.

§5.1(d) · p.18

HbA1c of at least 7.0% and no greater than 10.5%, based on the most recent value within 90 days before screening.

Synopsis · p.3

Key inclusion: adults aged 40–75 with type 2 diabetes, eGFR 30–59, and HbA1c 7.0–10.0%.

§5.2(b) · p.19

Participants with any history of chronic dialysis or kidney transplantation will be excluded.

§5.1(f) · p.18

Able and willing to provide written informed consent and to comply with study procedures, in the opinion of the investigator.

Structured criteria
  • §5.1(d) · p.18HbA1c of at least 7.0% and no greater than 10.5%, based on the most recent value within 90 days before screening.
    Analyte
    HbA1c
    Operator
    Between (inclusive)
    Range
    7.0–10.5 %
    Value used
    Most recent
    Window
    90 days before run date
    Review status
    Pending professional approval

    Passages disagree: the synopsis (p.3) says ≤ 10.0 %; §5.1(d) (p.18) says ≤ 10.5 %. A reviewer must choose which applies.

In TrialBridge, a proposal is approved only by a user with approval rights, after comparing it with the protocol text. Approval applies to a whole criteria version and is recorded in the audit trail.

This is a website preview with synthetic data. Marking it reviewed here changes only this page and is not saved.

Fig. 1 — Protocol passages and structured criteria. Select a criterion to highlight its source. Synthetic protocol SYN-CKD-201 v1.1; proposals are pre-written for this preview. Criteria that need judgement stay with screeners — not everything in a protocol can be checked against data.

Potential matches, with the gaps shown — not hidden.

Approved criteria run only against datasets your organisation has authorised for the trial. Each record is evaluated criterion by criterion as Met, Not met or Unknown. Missing data is never counted as a “no”.

1

Trial

SYN-CKD-201 · T2D with moderate CKD

2

Approved criteria

v1.1 · 9 data-checkable · 3 left to screeners

3
Dataset

Demo playback: these results were computed in advance from synthetic records.

Query preview

Evaluate approved criteria v1.1 against DS-A as of the run date. Each record gets a result per criterion: Met, Not met or Unknown. Records with any Unknown stay in the list, marked with their data gaps.

  • HbA1c in last 90 days82 %
  • eGFR in last 90 days91 %
  • NYHA class (if heart failure)64 %

Field coverage in DS-A · illustrative synthetic profile

A potential match is a starting point for screening, not a confirmed eligible participant. Unknown means the dataset can’t answer the question — a coordinator can.

A shared screening queue, scoped to each site.

Coordinators review evidence, request missing information and record outcomes with a reason. Investigators see the candidates referred to them. Try a status change — only permitted transitions are offered.

33 records · showing 8

CND-0042

SYN-CKD-201 · SITE-02 · reviewer A. Reyes · contact permission: Unknown

Awaiting Review

Criteria checklist

  • I1Age 40–75Met
  • I2Type 2 diabetes recordedMet
  • I3eGFR 30–59, ≤ 90 dMet
  • I4HbA1c 7.0–10.5 %, ≤ 90 dMet
  • E2Dialysis / transplantNo record found
  • E3NYHA class IVUnknown
  • I6Able to consentNot evaluated against data

Missing information: E3 — Heart failure recorded; NYHA class not recorded. The data can’t answer this; a coordinator can.

Activity history

  1. 2026-11-03 07:12SystemAdded from cohort run COH-0007 (criteria v1.1)
  2. 2026-11-03 07:12SystemAssigned to SITE-02 by catchment rule
  3. 2026-11-03 08:05K. MensahReviewer set to A. Reyes

Workflow states record what a person decided and why. They are not automated clinical determinations — final eligibility is decided by the investigator under the protocol.

Operational workflow states

  • Awaiting Review — added from a cohort run; no one has looked yet.
  • More Information Required — a reviewer needs data the dataset couldn’t provide.
  • Potentially Eligible — a coordinator found nothing disqualifying so far.
  • Investigator Review — referred to the site investigator for their judgement.
  • Not Eligible — a reviewer confirmed a failing criterion and recorded why.

These record human decisions in a workflow. TrialBridge never sets them automatically.

Find the bottleneck while there’s still time to act.

Funnels, backlogs and data gaps are calculated from screening records. Each chart says what it measures and how — and can be read as a table.

Recruitment funnel

How many candidates reached each stage, and where the biggest drop happens.

  1. Identified95
  2. Review started4143 %
  3. Potentially eligible1741 %
  4. Investigator review1165 %
  5. Consent recorded655 %
  6. Enrolled467 %

Largest absolute drop is before review starts: 54 candidates are still awaiting a first review — a backlog, not screen failures.

Calculation. Candidates that ever reached each stage. Step % = stage ÷ previous stage. Consent and enrollment are events entered by site staff. Synthetic sample · SYN-CKD-201

Site workload by status

Each site’s assigned candidates, split by current screening status.

  • SITE-01Northfield Research Clinic38
  • SITE-02Calder Valley Medical Research Unit33
  • SITE-03Easton Ridge Clinical Research Center24
  • Awaiting Review
  • More Information Required
  • Potentially Eligible
  • Investigator Review
  • Not Eligible
Calculation. Count of screening records per site and current status. Synthetic sample · SYN-CKD-201

Screening backlog age

How long candidates have been waiting for a first review.

  • 80–3 days
  • 184–7 days
  • 218–14 days
  • 7> 14 days
Calculation. Days since each Awaiting Review record was added, grouped into four ranges. Synthetic sample · SYN-CKD-201

Data completeness in potential matches

57 of 95 potential matches have at least one criterion the data couldn’t answer.

  • HbA1c not in 90-day window31
  • eGFR not in 90-day window14
  • Both HbA1c and eGFR6
  • NYHA class not recorded6
Calculation. Potential matches grouped by which criteria evaluated as Unknown in cohort run COH-0007. Synthetic sample · SYN-CKD-201

Illustrative: computed from 95 synthetic candidate records for the fictional trial SYN-CKD-201. TrialBridge has not yet been used in a live study, and these are not customer results.

Designed for controlled access and a complete record.

These are design commitments in the product’s architecture. They are not certifications, and we haven’t yet completed independent audits.

Role-based access
Roles are scoped to trials and sites. Signing in alone grants access to nothing.
Controlled dataset access
A dataset can be queried for a trial only after two roles authorise it, with an expiry date.
Encryption in transit and at rest
TLS for every connection; managed encryption keys for databases, files and backups.
Audit events
Criteria approvals, data access, cohort runs and screening decisions are written to an append-only log.
Retention controls
Retention periods per record type, with confirmed deletion of datasets on request.
Separated identity data
Candidates carry pseudonymous IDs. The first release handles synthetic and de-identified data only.
Human approval workflows
AI proposes criteria from protocol text only — it never sees patient data. People approve and decide.

How the pieces fit — and which ones exist yet.

TrialBridge sits between your research systems. It doesn’t replace your CTMS, EDC or consent systems; it handles the pre-screening and screening work between them.

  • MVP scope Planned for the first release
  • Planned · V2 On the roadmap, not available
  • Future · V3 Later exploration

This is the proposed architecture. Nothing shown is in production use, and no third-party integration is live.

Research teams

Coordinators, reviewers, data managers, investigators and managers sign in with their own roles.

  • Browser access over TLS
  • MFA required
  • SAML / OIDC single sign-onPlanned · V2

Customer tenant boundary

TrialBridge application

Every request is checked against role, trial and site scope before any record is returned.

  • Role- and site-scoped access
  • Append-only audit events
  • Tenant isolation

AI boundary: no patient data

Protocol processing and criteria review

Protocol text is extracted with page anchors. Optional AI proposes criteria from protocol text only; people approve.

  • Text extraction (born-digital PDF, DOCX)
  • AI criteria proposals — protocol text only, tenant can switch off
  • Versioned human approval
  • OCR for scanned protocolsPlanned · V2

Private network · encrypted at rest

Authorised data connections

Datasets are imported under a data-use declaration and must be authorised per trial before they can be queried.

  • CSV import of synthetic or de-identified dataMVP scope
  • FHIR R4 bulk exportPlanned · V2
  • OMOP CDMPlanned · V2
  • Identifiable data tierPlanned · V2

Cohort discovery and screening

Deterministic evaluation of approved criteria; potential matches go to human screening queues.

  • Met / Not met / Unknown per criterion
  • Pseudonymous candidate IDs
  • Recorded rationale

Research operations and analytics

Funnels, backlogs and reports computed from screening records and site-entered events.

  • CSV / PDF reportsMVP scope
  • Scheduled reportsPlanned · V2
  • CTMS enrollment syncFuture · V3

Who TrialBridge is being designed for.

Intended use cases, not existing deployments. We are looking for research teams to shape the first release with us.

  1. A

    Clinical research organizations

    Coordinate trial recruitment workflows across research programs.

    One criteria version per study, shared screening states across programs, and portfolio-level funnels.

    Protocol Studio · Screening · Analytics

  2. B

    Trial sponsors

    Gain clearer operational visibility into recruitment progress and screening bottlenecks.

    Aggregate funnels and screen-fail reasons by criterion, without access to patient-level records.

    Analytics · Reports

  3. C

    Research hospitals

    Organise protocol review, candidate screening and site-level activity.

    Query de-identified extracts the institution already governs, and keep identity resolution in-house.

    Data Connections · Cohorts · Screening

  4. D

    Research site networks

    Coordinate screening workloads and monitor site activity.

    Site-scoped queues, workload alerts and reassignment when one site falls behind.

    Sites · Screening

Bring greater structure to clinical trial recruitment.

Explore how TrialBridge can help your research team connect protocol requirements, authorised datasets, screening workflows and recruitment operations.