RESEARCH & DEVLOPMENT COMPLIANCE

Evidence that survives the handoffs.

Evidence that survives the
handoffs.

One spine from protocol design to CSR and CTD.

Our Cinical Compliance suotes connects feasibility, clinical operations, safety, quality, TMF, and submission so the thread you defend in inspection is the same

one that informed every decision — not rebuilt at each tool boundary.


The spine: shared identity, append-only audit, citeable lineage, FIVES scoring, and governed AI — across all 22 use cases, not layered on top of each silo.

One spine from protocol design to CSR and CTD.

Our Cinical Compliance suotes connects feasibility, clinical operations, safety, quality, TMF, and submission so the thread

you defend in inspection is the same one that informed every decision — not rebuilt at each tool boundary.


The spine: shared identity, append-only audit, citeable lineage, FIVES scoring, and governed AI — across all 22 use cases,

not layered on top of each silo.

One spine from protocol design to CSR and CTD.

Our Cinical Compliance suotes connects feasibility, clinical operations, safety,

quality, TMF, and submission so the thread you defend in inspection is the same

one that informed every decision — not rebuilt at each tool boundary.


The spine: shared identity, append-only audit, citeable lineage, FIVES scoring, and

governed AI — across all 22 use cases, not layered on top of each silo.

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The Problem Worth Solving

The Problem Worth Solving

Siloed risk models

Feasibility, EDC, CTMS, safety, eTMF, supply, and dossier stacks each narrate their own compliance story.

Portfolio oversight and inspection prep become late-cycle reconciliation projects.



AI without governance

Accelerators bolted on without a shared model registry, prompt versioning, or human review

routing produce outputs that cannot be traced to source evidence under scrutiny.



Submission divorced from execution

CSR and CTD content often lacks lineage to operational truth.

Inspectors cannot verify claims; deficiency letters and rework compound.

Siloed risk models

Feasibility, EDC, CTMS, safety, eTMF, supply, and dossier stacks each narrate their own compliance story.

Portfolio oversight and inspection prep become late-cycle reconciliation projects.



AI without governance

Accelerators bolted on without a shared model registry, prompt versioning, or human review

routing produce outputs that cannot be traced to source evidence under scrutiny.



Submission divorced from execution

CSR and CTD content often lacks lineage to operational truth.

Inspectors cannot verify claims; deficiency letters and rework compound.

Siloed risk models

Feasibility, EDC, CTMS, safety, eTMF, supply, and dossier stacks each narrate their

own compliance story. Portfolio oversight and inspection prep become late-cycle

reconciliation projects.



AI without governance

Accelerators bolted on without a shared model registry, prompt versioning, or

human review routing produce outputs that cannot be traced to source evidence

under scrutiny.



Submission divorced from execution

CSR and CTD content often lacks lineage to operational truth. Inspectors cannot

verify claims; deficiency letters and rework compound.

One Architecture — Three Layers

Every division consumes the same Layer A + B services. Nothing bypasses the compliance spine.

Every division consumes the same Layer A + B services.

Nothing bypasses the compliance spine.

  1. Compliance Foundation

Policy & risk class, identity & access, append-only audit, AI governance, data governance.

Policy & risk class, identity & access, append-only audit, AI governance,

data governance.

Policy & risk class, identity & access, append-only audit,

AI governance, data governance.

  1. Data & Evidence

Master entities, lineage & provenance, regulatory feeds, clinical ops data, CSR/CTD/TMF objects.

Master entities, lineage & provenance, regulatory feeds, clinical ops data,

CSR/CTD/TMF objects.

Master entities, lineage & provenance, regulatory feeds, clinical ops

data, CSR/CTD/TMF objects.

  1. 22 use-case divisions

From feasibility to inspection readiness — each tied to shared compliance services.

From feasibility to inspection readiness — each tied to shared compliance

services.

From feasibility to inspection readiness — each tied to shared

compliance services.

How Clinical Compliance works — Design to Filing

Business Outcomes —
Who It Benefits

  1. Plan & Prioritize

Feasibility, portfolio risk,

site strategy

Ingest literature and competitive landscape; score

countries and sites; heat-map portfolio risk with

drill-down and freshness labels.

Classifies outputs and sets AI oversight level —

human-in, on, or over-the-loop — before anything

is submission-bound.

Global Trial Feasibility Portfolio Risk

Site Selection Clinical development

  1. Execute & Integrate

Enrollment, data quality, supply,

unified trial data

Queries and risk-based monitoring; IMP and GDP

handoffs with plain-language supply intelligence;

EDC, CTMS, and safety integrated with full lineage.


Study workspace surfaces recruitment, supply, and

compliance status in one place — every KPI opens

to source evidence.

Clinical Data Quality Clinical Supply Chain

Patient Recruitment Clinical Data Integration

Clinical operations

  1. Protect & Correct

Safety, AE reporting,
deviations, CAPA

ICH E2B(R3) mapping and deadline tracking;

AI-assisted narratives with mandatory human review;

major deviations route to CAPA with GCP citations.


Builds the audit trail continuously — signal to CAPA

to effectiveness check, not reconstructed before

inspection.

Safety Event Triage Adverse Event Reporting

Protocol Deviation Mgmt Corrective Action

Safety & quality

  1. Document & Govern

TMF, contracts, DMC, CRO oversight

TMF, contracts, DMC, CRO

oversight

DIA-aligned TMF with QC and inspection readiness;

agreement risk and redlines with legal workflow;

blinded DMC reporting with dual-key controls.

Vendor scorecards and audit findings link forward to

CAPA and backward to source evidence.

Trial Master File Clinical Trial Agreements

DMC Support CRO Performance & Audit

Quality & Legal

Safety Event Triage Adverse Event Reporting

Protocol Deviation Mgmt Corrective Action

Safety & quality

  1. Validate & File

Submissions — incident to the

agency's inbox

Same rule model from study close to dossier.

Submission room tracks ICH M4 completeness,

blocking vs. warning findings, and human

authorization before transmission. Inspection

readiness reconstructs protocol → data → safety →

CSR → CTD for chosen slices.


Validates against the agency standard without

rewriting the compliance story from scratch.

Your validated publishing and gateway processes

remain yours — TCCS aligns evidence, checks, and

audit to one spine.

Submission Validation

Regulatory Submission Tracking

Inspection Readiness Regulatory affairs

Outcomes — Who It Benefits

CLINICAL OPERATIONS

One study truth

Integrated views with freshness SLAs — every metric opens to

source, less “which spreadsheet is authoritative?”

SAFETY & QUALITY

Defensible Narratives

Expedited deadlines, immutable signed records, and deviation-to-

CAPA traceability that matches inspector expectations

Expedited deadlines, immutable signed records, and

deviation-to-CAPA traceability that matches inspector expectations

REGULATORY AFFAIRS

Less dossier rework

Submission-bound content classified early; CTD validation and

readiness exports align to the same evidence graph

MEDICAL & CLINICAL SCIENCE

Signal without silos

Cross-study and site context with lineage to source data —

medical monitoring without parallel risk models

Cross-study and site context with lineage to source data — medical

monitoring without parallel risk models

What Leaders Recognize

Illustrative composite quotes for positioning — not attributed to named customers unless separately approved.

Illustrative composite quotes for positioning — not attributed to named

customers unless separately approved.

“We don’t need another dashboard.

We need one audit story from first patient to filing.”

VP, Clinical Development

“If your AI can’t show model, prompt version,

and source pointer, it doesn’t belong in a GCP

workflow.”

Head of Quality & Compliance

“Portfolio risk is fiction if each study’s tools

don’t share identity and evidence lineage.”

Chief Medical Officer — global biopharma

Compliance is infrastructure. Automation without citeable rules and lineage is not defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

Compliance is infrastructure.

Automation without citeable rules and lineage is not defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

Compliance is infrastructure.

Automation without citeable rules and lineage is not

defensible in audit — or when the agency asks for the thread.

22 capability divisions. One compliance backbone.

22 Use Cases

Entitlement-controlled per tenant. Compliance at core. Production Ready

  1. Global Trial Feasibility

PLANNING

Literature & landscape intelligence, feasibility briefs.

  1. CRO Performance & Audit

OVERSIGHT

Vendor scorecards; findings → CAPA.

  1. Portfolio Risk Dashboard

RISK

Cross-study heat map, drill-down, alerts.

  1. Safety Event Triage

SAFETY

E2B mapping, deadlines, signal detection.

  1. Clinical Data Quality

DATA

Queries, RBM, ALCOA+ scoring.

  1. Regulatory Submission Tracking

  1. Regulatory Submission
    Tracking

REGULATORY

Milestones, CTD states, audit trail.

  1. Site Selection

OPERATIONS

Site profiles; AI-assisted recommendations.

  1. Patient Recruitment

OPERATIONS

Funnel, diversity, IRB-aligned materials.

  1. Adverse Event Reporting

SAFETY

AE/SAE, narratives, PSUR pathways.

  1. Protocol Deviation Mgmt

QUALITY

GCP categories; auto-route to CAPA.

  1. Clinical Supply Chain

SUPPLY

IMP, GDP, plain-language query, expiry alerts.

  1. Regulatory Intelligence

REGULATORY

HA feeds, inspection patterns.

  1. Trial Master File

DOCUMENTS

DIA model, QC, completeness.

  1. Clinical Trial Agreements

LEGAL

Clause extraction, redlines, CLM hooks.

  1. DMC Support

GOVERNANCE

Blinded reports, dual-key unblinding.

  1. Inspection Readiness

QUALITY

Mock inspections, end-to-end traceability export.

  1. Trial Cost Optimization

FINANCE

Budget vs. actual, forecasts.

  1. Patient Retention

GOVERNANCE

Visit compliance, dropout risk monitoring.

  1. Clinical Data Integration

DATA

Unified view, lineage, conflict resolution.

  1. Submission Validation

REGULATORY

ICH M4/M8, cross-module checks, human release.

  1. Trial Risk Assessment

RISK

QTL, composite risk, RBM triggers.

  1. Site Performance Analytics

OPERATIONS

KPIs, benchmarking, exemplar modules.

See The Thread On Your Roadmap

See The Thread On
Your Roadmap

We map your stack — feasibility through filing — onto one backbone with phased, realistic boundaries.

No generic deck: bring your studies and systems; we'll map evidence flow and governance gaps.

We map your stack — feasibility through filing — onto one backbone with phased,

realistic boundaries. No generic deck: bring your studies and systems;

we'll map evidence flow and governance gaps.

Request a Conversation →

Request a Conversation →

Watch 10-min walkthrough →

Watch 10-min walkthrough →