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Electronic data capture · Clinical research · Available

Stateam EDC

One platform from study design to statistical output.

Overview

Stateam EDC is an electronic data capture platform for research teams that need clean study operations and analysis-ready outputs. It does not stop at data capture: it carries the study through data quality, analysis and reporting, with Stateam's implementation and biostatistics teams behind it.

Most studies don't break at data entry. They break in the fragmented work between protocol and analysis: building, governing, monitoring, cleaning and exporting the data. Stateam EDC brings that work into one system and one team.

At a glance

Built forAcademic research teams, research centers, health programs and government-funded studies
CoversProtocol to analysis-ready dataset
IncludesPlatform, study implementation, data management and biostatistics support
Data handlingDe-identified program data, protected health information (HIPAA and NIST controls), and studies whose data goes to FDA (21 CFR Part 11 configuration)
DeploymentHosted and maintained by Stateam, or handed over for your team to host

Where studies break

Study startup burden

Case report forms, visits, roles and approvals create drag before the first participant is enrolled.

Tool fragmentation

EDC, survey tools, shared drives, spreadsheets and email do not work as one system.

Data cleaning happens too late

Biostatistics often receives data only after avoidable cleanup and rework.

Compliance is unclear

Auditability, governance and oversight are inconsistent across teams.

Enterprise EDC is often too heavy

Systems built for large sponsor programs can be too costly, complex and slow for research teams.

What teams actually need

Faster study launch, less coordinator and data-manager burden, cleaner interim and final datasets, simpler governance and biostatistics-ready outputs.

From protocol to statistical output

1. Protocol

Study design, endpoints, visits and inclusion criteria.

2. EDC build

Case report forms, variables, edit checks, roles and audit trail.

3. Participant capture

Surveys, patient-reported outcome forms, consent workflow and reminders.

4. Operations

Queries, monitoring views, protocol deviations and enrollment tracking.

5. Data management

Data dictionary, cleaning rules, export standards and QC logs.

6. Biostatistics

Analysis-ready datasets, tables, figures and listings, and interim reporting.

The package: platform, implementation and biostatistics

EDC workspace

Case report forms, visits, variables, edit checks, role-based access and a full audit trail.

Study implementation

Protocol-to-database mapping, build support, templates and user training.

Clinical trial workflow

Query handling, monitoring views, protocol deviations, multi-site support and data-quality checks.

Biostatistical processing

Analysis-ready datasets, variable specifications, QC support, and tables, figures and listings.

Analytics engine (optional)

Built-in analysis for teams without a staff statistician.

Research support layer

Support for principal investigators and coordinators, center-level workflows, and packaging that fits grant-funded and pilot studies.

The supported middle lane

More supported than self-service survey and data-capture tools. Lighter and more research-friendly than enterprise EDC built for large pharmaceutical programs. More valuable than software alone.

Stateam helps research teams run the study, not just collect the data.

Built for the data you hold

De-identified and program data

A standard configuration for studies and programs that hold no protected health information.

Protected health information

HIPAA-aligned configuration with NIST-based security controls for any study that holds PHI.

Data submitted to FDA

A 21 CFR Part 11 configuration, with validation support, for studies whose data will support a regulatory submission.

The data you collect decides the configuration, and we help you choose it at the start.

Two ways to run it

Stateam-managed

We host, secure, maintain and update the platform for you.

Full handoff

We build it and hand it over, and your IT team hosts and runs it.

Getting started with a pilot

Start with a fixed-scope pilot on de-identified data: we build one study, your team uses it, and you see the analysis-ready output before committing to more. The pilot work carries forward into the full build.

To arrange a demo or discuss a pilot, contact us.

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