4 days avg. reconciliation cycle (vs. 3 weeks manual)
97.3% data validation pass rate on first submission
CDISC SDTM & ADaM compliant output
21 CFR Part 11 audit trail on all transformations
Platform Capabilities

Purpose-built for clinical data operations

Pharmaceutical teams spend too much time moving data between systems. MLPipeKit eliminates that friction — from site upload to NDA-ready datasets.

EDC & eCRF Integration

Connects to Medidata Rave, Oracle Clinical, and Veeva Vault EDC via standard API. Ingests patient-level data in CDISC ODM format without manual export steps.

Automated Query Resolution

Applies sponsor-defined validation rules against incoming data. Flags discrepancies at the field level, routes queries to the responsible site, and tracks resolution status — all within one interface.

CDISC SDTM/ADaM Output

Transforms cleaned trial data into SDTM domains and ADaM datasets ready for statistical analysis. Define domain mappings once; apply them across all studies.

21 CFR Part 11 Audit Trail

Every data transformation, query, and resolution is logged with timestamp, user identity, and reason for change. Audit reports export directly to PDF for regulatory submission packages.

Study-Level Monitoring Dashboard

Track open queries per site, reconciliation progress by visit, and database lock readiness across multiple concurrent studies in a single view.

Statistical Programming Handoff

Delivers ADaM datasets with annotated specifications to SAS and Python statistical environments. Reduces the annotation review cycle that typically adds 5-8 days before TLF generation.

Workflow

From site data to locked database

01

Connect your EDC

Point MLPipeKit at your EDC instance. We support Medidata Rave, Oracle Clinical One, and Veeva Vault. Setup takes under two hours with our onboarding team.

02

Define validation rules

Import your existing edit checks or build new ones using the rule editor. Rules are versioned, so you can trace which check caught which discrepancy in any locked study.

03

Run automated reconciliation

MLPipeKit pulls data from all sites, runs your validation stack, and generates query listings grouped by site coordinator. Manual query entry drops by 78% on average in the first cycle.

04

Export CDISC-ready datasets

Once queries are resolved, the platform maps cleaned data to your SDTM and ADaM specifications. Final datasets include metadata, define.xml, and a full transformation audit log.

Applications

Built for the phases that matter

Phase II Efficacy Trials

Smaller patient populations, tight timelines. MLPipeKit's rule editor lets you set up validation for a 120-patient Phase II in an afternoon rather than over two weeks of CRO back-and-forth.

Phase III Multi-Site Studies

Across 40+ investigator sites, query volume compounds quickly. Our cross-site discrepancy view catches systematic data entry patterns — the kind that appear at Site 12 but are caused by a protocol ambiguity that affects all sites.

NDA Submission Readiness

FDA Technical Rejection Criteria cover dataset conformance issues that are avoidable. MLPipeKit runs Pinnacle 21 Community checks as part of every SDTM export so conformance errors surface before the submission package leaves your organization.

Fewer queries. Faster lock. Earlier submission.

Teams running Phase II–III trials typically see database lock move forward by 11–18 days after integrating MLPipeKit into their data operations workflow.

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