LM EvidenceBridge unifies your entire RWE lifecycle — from protocol design to peer-reviewed publication — across pharma sponsors, CROs, hospital sites, and regulators on a single connected platform. 27 modules. 4 workspaces + patient portal. Zero silos.
3
Studies
12
Pending OCR
234
Patients
EMPA-RWE-001 · Sites
Upload Pipeline
OCR RunningUploaded
Extracted
Confirmed
Approved
From first protocol draft to regulatory submission and peer-reviewed publication — every workflow, every stakeholder, every data standard in one place.
eCRF builder, amendment tracking, visit schedule design, multi-arm study configuration, and registry linkage.
Role-gated structured data entry with SDV indicators, DCF query management, calculated fields, edit checks, and electronic lock & sign.
PDF/image upload pipeline for retrospective studies: OCR extraction, AI field mapping, CRA review & approval, and participant linkage.
CTCAE grading, SAE flags, regulatory reporting clocks, authority notification matrix, and WHO ATC-coded concomitant medications.
MMRM, Kaplan–Meier, Cox regression, propensity score matching with 14 covariates, and multiplicity correction gating.
Protocol-driven visit matrix, window tracking, missed-visit alerts, and multi-visit PRO trend analysis (PHQ-9, EQ-5D-5L, SF-36).
Tamper-evident audit log with before/after diffs, e-signature hash, IP address, actor identity, and reason for change.
ICH E3 / CTD 5.3.5.1 CSR drafting, STROBE checklist, CRediT authorship taxonomy, journal selector, and eCTD XML export.
One-click export to FHIR R4 Bundles, CDISC ODM 1.3.2, OMOP CDM v5.4, SDTM domains, Flat CSV, and SAS XPT.
21 CFR Part 11, ICH E6(R3), EMA RWE framework, PMDA guidance, and regional data privacy regulation alignment out of the box.
Token-based patient portal with QR self-registration, eConsent with countersign, medication diary, AE self-reporting, and caregiver proxy access.
A structured, compliance-first workflow that keeps every stakeholder aligned and every data point audit-ready.
Protocol authoring, SAP definition, eCRF builder, visit schedule, site selection, investigator training, and ethics documentation.
Multi-site eCRF data entry, retrospective chart upload with OCR, visit tracking, real-time query management, and safety surveillance.
Statistical analysis, clinical study report drafting, regulatory submission packages, journal submission, and post-market evidence.
The Microsite Admin portal manages the entire retrospective upload pipeline: drag-and-drop PDF/image upload, AI-powered OCR extraction, field mapping review, CRA approval, and patient-level linkage — all in a Study → Site → Patient hierarchy.
Upload Pipeline · AIIMS Delhi
4
Uploaded
8
Extracted
6
Confirmed
14
Approved
PT-001 — Discharge Summary
OCR confidence: 94%
PT-002 — Lab Reports Q3
OCR confidence: 87%
PT-003 — Outpatient Notes
OCR confidence: 72%
Automated SUSAR detection with configurable reporting clocks, authority notification matrices, CTCAE v5.0 grade assignment, and causality assessment — built for both commercial and academic RWE studies worldwide.
Safety Monitoring · Study RWE-001
Diabetic Ketoacidosis
SUSAR · Unexpected
✓ Reported Day 6
Acute Kidney Injury G3
SUSAR · Unexpected
7d deadline: 1d remaining
Hypovolaemia Grade 3
SUSAR · Unexpected
✓ Reported Day 5
8
Total AEs
3
SAEs
3
SUSARs
Audit Trail · 21 CFR Part 11
Dr. R. Sharma · HbA1c → 7.2%
Dr. R. Sharma · Baseline CRF
DM: P. Menon · Visit M3 Forms
PV: A. Reddy · SUSAR-002
Study Manager · OMOP CDM v5.4
21 CFR Part 11 · §11.10(e) · Tamper-evident · SHA-256 e-signature
Every field change, signature, and export is captured in a tamper-evident audit trail with SHA-256 e-signature hashing, IP address logging, and before/after data diffs. Inspection-ready from day one.
The EvidenceBridge patient portal gives study participants direct, secure access to their consent, diary, visit schedule, and AE reporting — all from any mobile browser via a QR code. No app download. No password.
Patient Portal · Study Participant
eConsent
EMPA-RWE-001 · Version 2.0 · English
23
Diary Entries
68
Doses Logged
1
AEs Reported
3 / 7
Visits Done
Access via QR code
No app · No password · Any device
Pharma sponsor, operations, hospital site, microsite admin, and patient — each gets a purpose-built workspace with role-scoped access and zero over-sharing.
Internal operations team workspace for platform administration, data management, statistical analysis, and medical writing.
Roles
Key Modules
Pharma, CRO, and medical affairs workspace for study oversight, site management, analytics, and publication.
Roles
Key Modules
Site-scoped workspace for investigators and coordinators — only the patients and visits assigned to your facility.
Roles
Key Modules
Purpose-built portal for retrospective chart review: upload, OCR extraction, CRA approval, and patient-level analytics — all in a Study → Site → Patient hierarchy.
Roles
Key Modules
Token-based patient portal — no app, no password. Patients access via QR code or unique link from their coordinator.
Roles
Key Modules
Regulatory & interoperability standards
Each persona gets a tailored experience with exactly the data, tools, and workflows they need.
Principal Investigator
0
Platform modules
0+
Roles across 4 workspaces
0%
ALCOA+ data coverage
0.9%
Platform uptime SLA
Every study is accessible via authenticated REST API. Export to your sponsor's data warehouse in FHIR R4, OMOP CDM, CDISC SDTM, or flat CSV with per-study rate limits and full audit trail of every export.
# Export as FHIR R4 Bundle
GET /api/v1/studies/rwe-001/export/fhir
Authorization: Bearer sk_live_****
"resourceType": "Bundle",
"total": 234,
"entry": [ Patient · Observation · Condition ]
White Paper · 2026
A platform guide for RWE study leaders on eliminating silos, accelerating timelines, and producing publication-ready evidence at scale.
A 28-page strategic guide for study directors, biostatisticians, and clinical operations leads on how purpose-built RWE platforms eliminate data silos, compress timelines, and deliver inspection-ready evidence.
Want to read instead? Request read access →
In a 45-minute session, we'll walk through your indication, visit schedule, site structure, and reporting requirements — live on the platform.