GenPrime · Initialization·vision pitch · 2026-05-28

Advanced Clinical OS

One operating system across the clinical stack — documentation & planning, multi-modal data pipelines, operational systems, and a copilot brain — anchored on a real-world data spine that follows patients from year 0 to year 15.

pitch.genprime.uk

Phase 1 · vision diagram (v0.2 · content audit)

The whole map · three lanes + RWD · phase-aligned timeline

Documentation / PlanningDataClinical CopilotRWD

⌘/Ctrl + wheel · zoomdrag · pan·node click · open linked repov0.3 · edit: web/src/lib/vision-schema.ts

Lane 1

Documentation / Planning

From the Clinical Development Plan (CDP) through Clinical Protocol, Eligibility, and SAP — feeding a constellation of derived docs (IB · ICF · CRF design · DMP · MOP · DSUR · PSUR · RMP · Briefing Book · Pharmacy & Lab Manuals) — then up through CTA/IND trial authorization and finally the eCTD M1–M5 submission package (NDA / BLA / MAA).

clinical-cdpCDP · Phase 1/2/3 strategy
clinical-csr-writerCSR drafting (ICH E3)
clinical-eligibility-criteriaEligibility platform

Lane 2

Data

Patient baseline, vitals, EMR, follow-up, ePRO, imaging, genomic, wearables, AE, dose history — through a mid-layer (VLM · OCR · NLP · MedDRA/WHODrug coding · SDV · edit checks · de-identification) — into the operational sinks (EDC / Lab / Biorepository) and operational systems (CTMS / IWRS / Pharmacovigilance DB). Everything lands in the wide & sparse SDTM-like Data Warehouse; DB Lock + Unblinding gates the ADaM → TFL → CSR spine, with C.A.P. forking off for HEOR, Bayesian / adaptive, and ML modeling. prePK runs as a side branch from Lab back into the warehouse.

prepk-pipelineMulti-modal PDF → narrative
edc-workflowEDC source
clinical-csr-writerTFL → CSR sink

Lane 3

Clinical Copilot

Two tiers. Decision-makers (P.M. · P.D. · P.I. · CMO) own strategic and clinical calls. Specialist advisors (CRA · Data Mgr · Biostat · PV · RA · Med Writer) own execution quality. External KOLs sit alongside as a third tier for advisory weight on disease, method, and regulatory dimensions. The copilot is implicit at every junction across Lanes 1 and 2 — we keep its cross-lane edges off the diagram for clarity.

clinical-platformCapability building · KPI

RWD · Real-World Data subgraph

Long-tail follow-up (year 0 → 15) pulled out of the Data Warehouse on a separate downstream branch. Sources: disease registries · claims · EHR longitudinal · wearables · mortality · patient panels. Outputs: PMS · HEOR · RWE · label extensions · off-label surveillance · comparative effectiveness · subpopulation evidence — the assets that power label expansion, HTA dossiers, and payer negotiation.