From protocol to study‑ready deliverables in days, not months.
DocumentSpark extracts the structured facts inside your protocol once, then generates every downstream data management, regulatory, and SDLC validation artifact your trial needs: traceable to the clause it derives from, and re-reconciled when the protocol changes.
A team of people, retyping the same protocol by hand.
When a protocol is approved, a dozen specialists - across the sponsor, the CRO, data management, and regulatory affairs - each open the same document and start writing their own set of deliverables from scratch. They are all drawing from the same source, but they work independently and in their own formats. The documents disagree with each other before the trial even begins, and every protocol amendment forces the whole team to start reconciling all over again.
The same document, authored a dozen times over.
Every team that touches the trial reads the protocol and writes their own set of documents from scratch. The same fact ends up retyped a dozen ways, in a dozen different formats - without any of the authors reading each other's work.
The documents disagree from day one.
Because every author works independently, almost no two documents match. Catching the mismatches is a manual job - someone has to compare the documents line by line. The errors that slip through are discovered weeks or months later, often by an auditor.
One missed change cascades for the life of the trial.
When the protocol is amended, someone has to find every document the change touches, open it, edit it by hand, and re-route it for review. Miss a document and the inconsistency follows the trial into data collection — where it becomes expensive to unwind.
Four to nine months before the first patient.
Writing, reviewing, and reconciling the document set sits squarely on the critical path between an approved protocol and enrolling the first patient. Every week added there is a week the trial isn't running.
Between an approved protocol and the first patient enrolled in a mid-sized trial.
Stand-alone documents a study team has to write and keep in sync - entirely by hand.
Industry estimates of trial cost driven by mid-study changes and the manual reconciliation they trigger.
One protocol in. A complete study package out.
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Ingest
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Extract
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Generate
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Validate
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Export
Five stages move a protocol from PDF to a deployment-ready package of CRFs, plans, specifications, and regulatory documentation; with every artifact linked to the protocol clause it derives from and re-checked whenever the protocol changes.
Every artifact is bound to the protocol clause that produced it.
The Protocol Intelligence workspace shows the structured model extracted from your protocol: arms, population, schedule, interventions: reviewable side-by-side with the source clause. Downstream generators consume the same fact base, so every deliverable inherits the same canonical numbers.
Protocol Analysis Complete
Protocol uploaded and analyzed. Fact base ready for downstream generation.
Study Design
- Type Interventional
- Phase II / Feasibility
- Blinding Double-blind
- Randomization Non-randomized
Population
- Target size 20 subjects
- Age range ≥ 18 years
- Condition Invasive lobular breast cancer
Twenty-eight artifacts. One fact base.
DocumentSpark generates the full set of artifacts required to operationalize a trial: from case report forms to the SDLC validation package to the submission-ready CDISC bundle.
Study setup
- D-01 Study Design Configuration
- D-02 Informed Consent Form
Case Report Forms
- D-03 Case Report Forms
- D-04 Annotated CRF
- D-05 CRF Instruction Guide
- D-06 Visit–Form Matrix
Data Management
- D-07 Data Management Plan
- D-08 Data Dictionary
- D-09 Edit Check Specification
- D-10 Data Review & Cleaning Plan
Pinned versions. Date-resolved against the FDA catalog.
CDISC · CDASH
CRF fields and data collection structures conform to the CDASH model out of the box, grounded against the CDASH IG v2.2 baseline.
ICH · E6 GCP
Generated artifacts preserve the traceability, version control, and audit posture required by ICH E6.
FDA · SDTCG
Submission-bound artifacts align with FDA's technical conformance requirements for study data.
One platform, every role in the study build.
01 / Sponsors
Compress study start-up timelines, reduce vendor dependencies, and maintain a single source of truth across portfolios. Hand a complete, validated package to any CRO or EDC.
02 / CROs
Standardize study build across clients and EDCs. Move faster on competitive bids by reducing the cost of upfront authoring work; compress UAT by validating against the source protocol.
03 / Clinical Data Managers
Author CRFs, edit checks, and the DMP from a structured protocol model instead of free text. Catch amendment impact before it reaches UAT through traceability.
04 / Regulatory, QA & PIs
Inherit traceability and version control by default. Submit study data aligned to the FDA conformance guide without rework.
See your protocol generate a study package.
Bring a redacted protocol or a representative document from a recent trial. We will walk you through the structured extraction, the generated deliverables, and the traceability model: live, against your own content.
- schedule 45 minutes * remote
- person Sponsor, CRO, or DM lead
- description Redacted protocol (optional)