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Architecture & interoperability

Your systems.
One continuous study.

Bring the materials you have and the systems you use. Clinstead connects the study’s intent, design and decisions in one model, with standards and adapters carrying the right definition to each destination. clinstead resolve will extend that continuity into collected data and analysis.

Explore your workflow with us
The Clinstead model

One study. All the way through.

Change the starting point.
The connection stays.

Start with
01 / Your starting pointProtocol · §4.2
Record body temperature in °C at the Week 4 visit.

The requirement starts in the source.

Source stays attached
clinstead designerStudy revision 02

Intent becomes working design.

Vital signsBody temperature
°C
Number fieldWeek 4Ready for review
Body temperature · Week 4Protocol §4.2
One shared study model

Source → Design → Decisions → Data → Analysis

Illustrative workflow. clinstead resolve is in development.

Demonstrated USDM 4.0 workflow

From USDM
to editable study.

Turn supported digital protocol definitions into forms, fields and visit assignments your team can inspect, edit and compile.

  1. Import and inspect.

    Map supported USDM study structures into the design. Keep source coverage and unresolved items visible for review.

  2. Build on the definition.

    Apply the reviewed structure to a new clinstead designer study. Refine the build and complete missing collection detail with reviewed templates.

  3. Check and compile.

    Run independent quality checks, inspect findings and generate configuration from the resulting study model.

What this demonstration establishes

A concrete path from a supported USDM 4.0 input to an editable study and compiled output. It includes separate source and output checks, review of coverage issues, and a read-only amendment comparison that preserves the baseline. It demonstrates the supported workflow; it does not imply every USDM construct or destination is covered.

Designed around your destination

Keep your EDC.
Build on what you know.

The value is a study definition your team can keep building on. Forms, visits, rules and their source context belong together—even when the work crosses systems.

Standards and destination adapters provide the exchange routes. CDISC ODM XML is one demonstrated output, alongside the demonstrated USDM study-design workflow. Neither format defines the limits of the Clinstead model.

How a destination is supported

Support is established for a named system, version and workflow. We check the supported constructs, mappings and import behaviour, identify gaps and agree the destination acceptance checks. A valid exchange file alone does not establish a working integration.

Discuss your systems and standards
A standard for each job

Right standard.
Right layer.

Each standard answers a specific question—from how a study is defined to how its data is collected, exchanged and analysed.

USDM / DDF
Study definition
A structured language for the study’s design and schedule. Clinstead has demonstrated a supported USDM 4.0 import, review, edit, quality-check and compilation workflow.
Biomedical Concepts
Clinical meaning
Reusable concepts and controlled terminology help connect an assessment’s meaning with the fields, units and response choices used to collect it.
CDASH
Data collection
Collection conventions help teams define what to capture and support a traceable route towards downstream tabulation.
ODM
Operational exchange
A format for exchanging study metadata and clinical data. CDISC ODM/XML is one demonstrated output route from Clinstead’s reviewed study structure.
SDTM / ADaM
Tabulation & analysis
SDTM structures tabulation data; ADaM structures analysis datasets and supports traceability to their sources. Both are planned outputs for clinstead resolve, with the statistical analysis plan guiding analysis definitions and derivations.
Define-XML
Dataset metadata
Machine-readable descriptions of datasets and variables. Planned alongside SDTM and ADaM output in clinstead resolve, connecting dataset metadata with reviewed mappings and derivations.

This is the standards landscape behind the architecture, not a claim of support for every version or operation. Explore CDISC DDF / USDM and CDISC foundational standards.

Evidence across the boundary

The goal is
a live study.

Identify the source snapshot and the files produced. Import into the agreed environment. Review the result against the study’s requirements. Complete the acceptance checks with the people responsible for activation.

The remaining tasks and their owners should be visible before a study goes live.

How we approach trust and evaluation
Bring the systems you use

Let’s move your study forward.

See your workflow with Clinstead

Start with the work you have. Show us where you want to go.