Design · Simulate · Execute · Submit
SPARC — The Clinical Development Intelligence Platform
SPARC connects protocol capture, statistics automation, clinical engine simulations, SAP authoring, ADaM/TLF builds, and regulatory packages into one governed workspace—mirroring the capabilities we highlight on K3’s Clinical Engine site.
At a glance
Design completion
78%
Digital protocol coverage
Simulations ready
6
Clinical engine batches
ADaM/TLF pipeline
Running
Automation status
Open issues
12
Quality & validation
Docs in draft
CSR v0.3 · SAP v1.0
Medical writing
Digital protocol core
AI-driven authoring for protocol metadata, SoA, estimands, and derivations.
Capture arms, visits, endpoints, estimands, and derivations inside a structured JSON protocol so SAP, ADaM, and TLF teams stay in sync automatically.
Open Study Designer →Simulation & optimization
Dose-escalation, adaptive, MAMS, GSD, multiplicity, and custom scripts.
Run R/Python engines, evaluate operating characteristics, and push optimal parameters back into the Digital Protocol with full provenance.
Run simulations →Executable SAPs
Templates and narratives wired to endpoints, estimands, and TLF shells.
Generate SAP sections that remain linked to study metadata so edits cascade safely and no dependency breaks on the path to submission.
Create SAP →Automation
ADaM specs, derivations, and TLF shells from a single metadata source.
Move from protocol to ADaM to TLF outputs with traceability and audit packs that mirror our clinical engine marketing site.
View pipeline →AI-assisted authoring
Protocol, SAP, and CSR drafts driven by structured metadata and results.
Leverage SPARC’s writing engine (and optional CoAuthor integrations) to draft and version regulatory documents with grounded citations.
Start drafting →Submission packages
Define.xml, reviewers guides, and traceable bundles in one click.
Produce compliance-aligned packages, validate integrity hashes, and export notarized audit bundles for every milestone.
Prepare submission →Validation & e-sign
Issues, validation rules, approvals, and tamper-evident audit trails.
Route approvals, track signatures, and surface validation alerts in one console so ClinOps, QA, and Biostats see the same truth.
Open review console →Single source of truth
Machine-readable JSON powering design, simulation, SAP, ADaM, and submissions.
Eliminate duplicate spreadsheets—one digital protocol drives simulations, analytics, and every downstream deliverable.
View Digital Protocol →Modeling
Dose-exposure modeling wired into design decisions.
Ingest curated PK/PD inputs, run exposure simulations, and feed key parameters back into protocol assumptions.
Metadata
Central store for ADaM datasets, TLF outputs, and definitions.
Govern traceable metadata, track reuse, and pin definitive specs before they flow downstream to regulators.
Connect
Wire SPARC into EDCs, CTMS, eCOA, and external writers.
Use MCP adapters and connector registry entries to safely bridge outside systems without redeploying code.
Enterprise onboarding & compliance
Need HIPAA/GxP multi-tenant hardening, MCP connectors, or custom authoring packs? Talk with the SPARC team.