Protocol to Define-XML. SDTM mapping included.
Seven agents read your protocol and draft USDM, DMP, eCRF, SDTM, ADaM, and Define-XML — each with a Part 11 trail and a human sign-off. Study builds that used to take 68 days close in under two weeks.
Seven agents. One audit trail.
Each agent is an isolated activity in Temporal — logged, versioned, and attributable. Nothing leaves the pipeline without a human approval unless you configure it otherwise.
Parser
The protocol PDF is the source of truth for every downstream artifact. Parser reads it, resolves the structure, and emits USDM v4.0 JSON. Every element maps back to the source section — so every downstream agent knows exactly where its instructions came from.
| Element | Section | Status |
|---|---|---|
| Endpoints (4) | §3.2 | Parsed |
| Arms (2) | §2.1 | Parsed |
| Visit schedule (12) | §6.1 | Parsed |
| Assessments (34) | §7.2 | Review |
| I/E criteria (18) | §4.1 | Parsed |
DMP Writer
The DMP is the first artifact every sponsor DM team produces and the first place weeks get lost. DMP Writer fills every section it can answer from the protocol, surfacing only the decisions that genuinely need a human. Near-complete plan in hours, not weeks.
| Section | Pages | Status |
|---|---|---|
| Objectives & Endpoints | 4p | Ready |
| Data Flow & EDC Config | 6p | Ready |
| Query Management | 3p | Review |
| Database Lock Procedure | 5p | Ready |
| Roles & Responsibilities | 2p | Ready |
| Protocol Deviations | 3p | Ready |
| SAE Reconciliation | 4p | Review |
eCRF Builder
eCRF build is where study timelines slip: field-by-field decisions, branching logic, edit checks, library alignment. eCRF Builder derives CDASH-compliant forms directly from the visit and assessment structure Parser extracted. Every field traces to the protocol section that required it.
| Module | Visits | Fields | Status |
|---|---|---|---|
| Demography | 1 | 12 | Done |
| Vitals | 8 | 24 | Done |
| AE / SAE | All | 31 | Review |
| Labs | 6 | 86 | Done |
| Concomitant Meds | All | 14 | Done |
| Primary Efficacy | 4 | 18 | Review |
SDTM Mapper
A wrong domain assignment or missed controlled term is a Pinnacle 21 finding at submission. SDTM Mapper works against CDISC Library CT, confidence-scores every mapping, and routes only the ambiguous cases to your DM lead. Never the obvious ones.
| eCRF Field | → SDTM | Confidence |
|---|---|---|
| AEDECOD | AE.AEDECOD | |
| VSPOS | VS.VSPOS | |
| LBMETHOD | LB.LBMETHOD | |
| EGMETHOD | EG.EGMETHOD | |
| RSDTC | RS.RSDTC |
ADaM Generator
ADaM is where the clinical story is built: the datasets your biostatisticians use to generate efficacy and safety outputs. ADaM Generator derives ADSL, ADAE, ADLB, and custom datasets from the SDTM layer, recording every derivation as a traceable rule.
| Dataset | Records | Derivations | Status |
|---|---|---|---|
| ADSL | 312 | 47 | Ready |
| ADAE | 891 | 23 | Ready |
| ADLB | 14,240 | 31 | Ready |
| ADTTE | 312 | 12 | Ready |
| ADRS | 1,248 | 18 | Review |
Query Candidate
Query aging is the most visible sign of a trial under pressure. Query Candidate scans live EDC data against your edit check library, proposes the query text, suggests the resolution, and routes it to the right coordinator — before a DM has opened a data review screen.
| Site | Field | Issue | Conf |
|---|---|---|---|
| 003 | LBORRES | Missing value | |
| 007 | AESTDTC | Date format | |
| 012 | MHTERM | Verbatim mapping | |
| 003 | VSPOS | Out of range |
Define-XML
Define-XML is the last artifact before submission and the most common source of a complete response letter delay. Define-XML Generator produces v2.1 with cSDRG narrative, validates against Pinnacle 21 rules inline, and surfaces findings before the package leaves the pipeline.
Study builds that used to take 68 days.
The work surfaces to a human, with context.
Every agent output carries its reasoning, its confidence, and the source passages it drew from. Approve, revise, or reject in one click. Your DM lead focuses on decisions that require expertise. Not translation work.
Four weeks. One protocol. End-to-end.
Ingest + USDM
We load your protocol PDF and your current CRF build standards. Parser emits USDM. Your team reviews the structural conversion and confirms the endpoint and visit structure.
DMP + eCRF
DMP Writer and eCRF Builder produce drafts. We configure the agency dial and edit-check library with your DM lead. Your team approves the forms before they go anywhere.
SDTM + ADaM
Against a source dataset (yours or a synthetic one), SDTM Mapper and ADaM Generator produce submission-ready outputs. Confidence scores and provenance on every mapping.
Review + handoff
Full walkthrough of the audit trail. Export Define-XML. Pinnacle 21 validation inline. You decide whether to continue to a paid engagement. Either way, you leave with your full artifact set.