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The Execution Platform
Can you run my study?

Operationalize every study
on the same substrate that produced the Executive Summary.

Clinical Intelligence explains the protocol. The Execution Platform operationalizes it across study startup, data collection, monitoring, reconciliation, coding, standards conversion, and submission preparation.

Every operational event runs on the same operating system that produced the Executive Summary. The same evidence model. The same provenance chain. One platform from protocol to submission.

Primary Operators

The teams that actually work on the Execution Platform.

  • CDM Lead
  • Medical Monitor
  • Data Manager
  • Clinical Research Associate
  • Regulatory Lead
  • Statistician
Execution Proof

Where the teams above actually work.

The Study Execution Workspace surfaces every operational dimension of an in-flight study on one screen. Sites. Subjects. Queries. Monitoring. Coding. Reconciliation. Data quality. Amendments. Submission progress. Operators across CDM, Medical Monitoring, CRA, Data Management, Regulatory, and Statistics use the same workspace, scoped to their role.

Study Execution Workspace
Representative · Demo

Representative demonstration. The workspace below illustrates how operators see a real customer's Study Execution surface inside PrismCDM. The values shown are representative for demonstration purposes and do not reflect any specific sponsor study managed by PrismCDM.

Representative Study

Phase 3 study · active mid-execution

The workspace surfaces every operational dimension on one screen. Click any tile to drill into the underlying records. This view updates continuously as operators across sites, monitoring, data management, coding, and reconciliation make decisions.

Study StateWhere the study stands today
Sites
18active

4 activating · 7 planned

Subjects
412enrolled

38 screening · 73 completed

Visits
142this week

487 scheduled · 30 days

Operational WorkloadWhat operators are working on right now
Queries
23open

5 aging · 18 closed this week

Monitoring Tasks
11in flight

3 at risk · 8 on schedule

Coding Queue
47pending

MedDRA + WHODrug

Reconciliation
3exceptions

external lab + safety

Data + AmendmentsData quality and protocol versioning
Data Quality
94%healthy

edit-check pass rate

Amendments
1in review

re-consent + site retraining queued

SDTM Coverage
89%mapped

domain set · v3.4 IG

Submission Progress
Rolls up into the Executive scorecard
Composite Readiness
67/ 100On Track

Accumulated from every site activation, query resolution, signed eCRF, and reconciled record above.

See Executive Scorecard →
Primary Users of This Workspace
  • CDM Lead
  • Medical Monitor
  • Data Manager
  • Clinical Research Associate
  • Regulatory Lead
  • Statistician
Generated
Date
Current generation date
Engine
Current platform version
Workspace Schema
Current schema
Corpus Snapshot
Current corpus
Build
Current release

Representative demonstration. The values shown are illustrative of the operational state a real customer's study would surface inside the Execution Workspace. No specific sponsor study is depicted here.

Execution Outcome

Below the workspace, the executive scorecard.

Submission readiness is not created at the end of a study. It is accumulated throughout execution. Every site activation, every query resolution, every signed eCRF, every reconciled record in the workspace above contributes a measurable increment to the composite readiness score below.

The Submission Readiness Dashboard is what an executive opens to ask “are we ready to submit?”. The workspace is what their teams open to make sure the answer is yes.

Submission Readiness
Representative · Demo

Representative demonstration. The structure below illustrates how a real customer's Submission Readiness Dashboard renders inside PrismCDM. The values shown are representative for demonstration purposes and do not reflect any specific sponsor study managed by PrismCDM.

Representative Study

Phase 3 study in mid-execution

The dashboard reflects a representative Phase 3 study several months into execution. Specific operational counts, scores, and dates are illustrative.

Submission Readiness Assessment
Submission Readiness Score (representative)
Composite readiness derived from protocol intelligence, study execution, clinical data quality, evidence generation, provenance integrity, and regulatory completeness.
73/ 100
On Track
Blocking Items (representative)
  • High3
  • Medium7
  • Low12
Next Required Actions (representative)
  • Resolve SDTM mapping validation
  • Complete medical coding review
  • Finalize protocol amendment
Study ProgressStructural view · representative
  1. Protocol
  2. Clinical Intelligence
  3. Study Execution
  4. Clinical Data
  5. Evidence Generation
  6. Regulatory Submission
Platform Readiness by Capability (representative)
Clinical Intelligence
Complete
100%

Trial Intelligence complete; findings + recommendations issued.

Execution
In Progress
67%

Operational workflow in progress: sites activated, monitoring active, data capture ongoing.

Evidence
In Progress
41%

Inspection Evidence Package accumulating continuously from operational events.

Provenance & Explainability
Complete
100%

Every finding, recommendation, and operational event traceable through the provenance chain.

Open Items (representative)
  • High

    Site network expansion recommended

    Analysis of eligibility criteria against the current site network indicates the screening pool narrows sharply at community oncology sites. Adding academic and tertiary community sites is recommended to protect screening volume.

  • Medium

    Protocol amendment recommended: eligibility expansion

    Analysis indicates current inclusion criteria constrain the addressable cohort below the enrollment target. An amendment expanding eligibility is recommended to protect enrollment velocity and reduce site rework.

  • Low

    Monitoring cadence adjustment recommended

    Combination-dosing logistics add monitoring touchpoints beyond the frontline oncology average. Cadence adjustment is recommended to keep monitoring aligned with the actual clinical workload.

Next milestone (representative)
First evidence package draft
Generated
Date
Current generation date
Engine
Current platform version
Assessment
Current assessment model
Corpus Snapshot
Current corpus
Build
Current release

Representative demonstration. The values shown are illustrative of the dashboard structure PrismCDM renders for customer studies. No specific sponsor study is depicted here.

Why The Status Quo Is Insufficient

Why clinical development needs a new operating system.

Clinical execution is fragmented.

Protocols, execution, evidence, and regulatory preparation live in disconnected systems. The work to keep them in sync absorbs the team's time.

AI without provenance is difficult to trust.

Clinical teams need to understand not only what AI recommends, but how it reached every conclusion. Without that, regulators and reviewers cannot accept it.

Evidence should be generated continuously, not assembled at the end.

Inspection readiness should emerge from daily operations, not become a last minute project before the audit window closes.

Intelligence without execution

is just analysis.

Every recommendation connects to a concrete operational action. Every operational event is traceable back to its source.

The Platform Substrate

One Platform. Four Capabilities.

Every artifact is produced by the same platform that powers Clinical Intelligence, Execution, Evidence, and Provenance across PrismCDM. The Brief is not a feature. It is proof of the platform.

Clinical Intelligence

Understand every protocol before execution begins.

Structured findings on complexity, operational burden, eligibility, schedule, and endpoints. Every finding is identified, scored, and traceable.

Execution

Transform protocol intent into operational decisions.

Recommendations connect each finding to a concrete next step. Site selection, screening reach, visit cadence, monitoring focus.

Evidence

Produce inspection-ready evidence continuously.

Every Brief, every workflow event, every reconciliation step generates the regulated evidence inspection teams expect, not assembled at the end.

Provenance & Explainability

Trace every regulated conclusion back to its source.

Engine version, assessment version, build hash, source layer, evidence anchor. Every finding and recommendation is reproducible and verifiable.

From Protocol to Submission

One platform across every deliverable your team scopes today.

The deliverables clinical teams actually build, in the order they build them. PrismCDM produces each one continuously as the study runs, with source-backed provenance and regulated audit history preserved end to end.

  1. Protocol
  2. ICF
  3. EDC
  4. SDTM
  5. ADaM
  6. SAP
  7. TFLs
  8. CSR
Produced by four platform capabilities
Clinical Intelligence
Execution
Evidence
Provenance & Explainability

Every deliverable, the same platform, the same provenance chain.

Who PrismCDM Is Built For

One platform across the entire clinical development sponsor stack.

Sponsors

Standardize how protocol risk is understood across every study in the portfolio.

Biotech

Run the same enterprise-grade Brief on every protocol with a lean clinical team.

CROs

Bring inspection-ready evidence and provenance to every sponsor engagement.

Academic Medical Centers

Generate Briefs for investigator-initiated protocols with the same rigor as industry.

Mid-size Pharma

Operate clinical development with the platform discipline of top-twenty sponsors.

Built for Regulated Clinical Development

Platform Principles

  • Multi-tenant
  • Append-only audit
  • 21 CFR Part 11
  • Role-based access
  • End-to-end provenance
  • Independently versioned engines
Early Access

See how Intelligence becomes operational decisions.

Bring one of your protocols. We'll generate the Executive Summary and walk every recommendation through to the operational decisions a real CDM Lead, Medical Monitor, and Site team would make on the Execution Platform.