FlashEDC · Protocol → EDC & Data Capture
Turn a Clinical Trial Protocol into an EDC Study — and capture the data.
FlashEDC analyzes a clinical trial protocol and generates the structure needed to build the study in an EDC environment, and the same structure is what sites and subjects then capture data against — with human review before anything is finalized.
Workflow
What FlashEDC does, in order.
Protocol
Protocol document supplied in PDF, DOCX, TXT, or RTF.
Protocol Analysis
Schedule of assessments and collection intent extracted.
Study Skeleton
Visit and folder structure with the assessment matrix.
Human Review
The skeleton is reviewed and corrected before expansion.
Forms & Fields
Forms, fields, controls, and code lists generated.
Edit Checks
Check specifications and programming code generated.
Second-Eye QC
Adversarial review; unresolved issues routed to a human.
EDC Study Design
Exportable study design for the EDC environment.
Data Capture
Sites and subjects enter data into the EDC study.
Capabilities
What it produces.
- Visit structure
- Forms & CRFs
- Fields & controls
- Code lists
- Edit checks
- Generated programming code
- Human review
- Second-eye QC
- Excel output
- SQL Server output
- Data capture
- Live study database
Study design in minutes
A protocol becomes a review-ready study design in roughly 10 to 30 minutes, depending on the size of the protocol. That is time to a draft a study builder can review — not time to a live study, which still requires the same review and approval as any build.
Protocol analysis
Accepts the protocol document as supplied — PDF, DOCX, TXT, or RTF — and reads the schedule of assessments, endpoints, and data-collection intent from it.
Study structure generation
Produces the visit and folder structure plus the assessment matrix that determines what is collected at each point in the study.
Form generation
Creates forms and CRFs with their fields, control types, and the code lists those fields draw on.
Edit-check generation
Generates edit-check specifications and the corresponding programming code, so checks are reviewable as specification before they are executed.
Human review
Every generated artifact is editable. Study builders review and correct the output before it is finalized.
Second-eye QC
An adversarial review pass looks for defects in the generated design, resolves what is safe to resolve, and routes everything unresolved to a human reviewer.
Data capture
The study the design produces is also where data is collected. Sites and subjects enter data into the EDC study built from the reviewed design, so the structure that was reviewed at study build is the structure data is captured against.
Long-running jobs
Protocol analysis runs as a background job with progress reporting, and can be cancelled or resumed without losing completed work.
Speed
Ten weeks of study build, drafted in under half an hour.
10–30 min
Protocol → review-ready design
Varies with protocol size. The output is a draft a study builder reviews and corrects.
~10 weeks
Manual baseline to go live
The effort the same build takes by hand today — the work the draft replaces.
The minutes figure is time to a draft ready for human review, not time to a live study. A study going live still follows the same review, approval, and validation path.
Human review
Generation is the fast part. Review is the point.
Generate
The pipeline produces a draft: skeleton first, then forms, fields, and checks.
Review
A study builder reads the draft and corrects it directly in the artifact.
Second-eye QC
An adversarial pass looks for defects, resolves what is safe to resolve, and escalates the rest.
Approve
Nothing is finalized until a named reviewer approves it.
Corrections are made in the artifact itself. Re-running the pipeline to get a different answer is not the workflow, because the reviewer's judgement has to survive into the final design.
Demonstration
See the workflow, step by step.
Evidence is more useful than adjectives. Walk the pipeline each product runs, and the artifact it produces at every stage.
FlashEDC · Study builder · Protocol SYN-014
IllustrativeVisits
- ScreeningV1
- Cycle 1 Day 1V2
- Cycle 1 Day 8V3
- End of TreatmentV4
- Follow-upV5
Form · Demographics
Edit checks
- EC-DM-001Generated
BRTHDTC not after consent date
- EC-DM-002Generated
SEX required at V1
- EC-DM-003Review
RACE: maximum 5 selections
- EC-VS-001Generated
SYSBP within 60–250 mmHg
Upload protocol
Document intake with format detection and job initialization.
Illustrative walkthrough using a synthetic protocol. No customer or confidential study material is shown.
Where it is today
A working internal tool, not a finished product.
FlashEDC runs in internal CRO use with strong engine fidelity: the generation path from protocol to study design is real and exercised on real protocols.
It currently depends on a specific EDC environment, which is the main constraint on how it is deployed today. We describe it that way rather than as a generally available commercial product.
Next step
See FlashEDC against your own protocol or dataset.
Bring a study and we will walk through what the platform produces — and where a human still has to decide.