The noise falls away.
The answer is obvious.
Signal transforms messy claims databases, EHR feeds, and registry data into regulatory-grade evidence packages — accepted by FDA, NICE, G-BA, and HAS.
"We went from raw claims data to an accepted HTA submission in fourteen weeks. Signal's team understood our oncology endpoints before we finished the briefing call."
Dr. Meredith Callahan
VP of HEOR, Veradex Oncology
Evidence accepted across global regulatory & HTA bodies
Every data type. One evidence package.
Signal ingests, harmonizes, and validates heterogeneous real-world data sources into a single, audit-ready analytical environment — no bespoke ETL required.
Claims & Administrative
Commercial, Medicare, Medicaid
EHR / EMR Feeds
Linked longitudinal records
Disease Registries
Condition-specific cohorts
Lab & Pharmacy
Biomarker & dispensing data
Patient-Reported Outcomes
PRO instruments, ePRO
Wearable / Digital
Continuous monitoring streams
Data Completeness
97.3%
Across linked claims-EHR datasets
Validation Pass Rate
99.1%
OMOP CDM conformance checks
Regulatory Acceptance
100%
FDA & HTA submissions, 2023–2025
"Can you handle linked claims-and-EMR datasets?"
Six data types. One validated environment.
Signal ingests Optum, IQVIA, Flatiron, Epic, Cerner, and custom registry feeds through pre-built connectors. We apply OMOP CDM harmonization, probabilistic patient matching across sources, and automated data quality checks against FDA fit-for-purpose criteria — before a single analyst writes a query.
Cardio-Metabolic · Retrospective Cohort
"Linked 2.3M claims patients to 640K EHR records in eight days. The merged dataset passed FDA's data quality review without a single deficiency letter."
8 days
Claims-to-EHR linkage
James Okafor, PhD
Senior Outcomes Researcher, Harlan Therapeutics
Validated Analytical Dataset
OMOP-harmonized · Audit trail complete
"What regulatory endpoints do you support?"
Every endpoint FDA and HTA bodies accept — built in.
From overall survival and progression-free survival to healthcare resource utilization, comparative effectiveness via target trial emulation, and burden-of-illness measures — Signal's endpoint library covers 40+ pre-validated definitions aligned to FDA's RWE Framework, NICE DSU guidance, and AMNOG methodology requirements.
Oncology · Comparative Effectiveness
"Our OS analysis using Signal's TTE framework was accepted by the G-BA without methodological queries. That had never happened in our history."
40%
Reduction in planned Phase III sample size
Dr. Priya Venkataraman
VP Medical Affairs, Solaris Biopharma
"How fast from protocol to final report?"
Fourteen weeks. Protocol to accepted submission.
Signal's AI-accelerated workflow compresses study cycle times by 30–40% versus traditional CRO approaches. Protocol design, cohort construction, analysis, and CSR drafting run on parallel tracks — not sequentially. You get a complete, reproducible study package with full lineage documentation before your advisory board.
Rare Disease · Burden of Illness
"We had a PDUFA date in four months. Signal delivered a complete RWE package — protocol, analysis, CSR, and HTA dossier — in eleven weeks. The submission was accepted."
11 weeks
Protocol to HTA submission
Sofia Lindqvist
HEOR Director, NordPharma Rare
Week 1–2
Protocol Design
Week 3–4
Data Ingestion & QC
Week 5–7
Cohort Construction
Week 8–10
Analysis & Validation
Week 11–12
CSR Drafting
Week 13–14
Submission Package
The conversation starts with
your data.
Tell us your therapeutic area and study design first. Our epidemiologists will come prepared with relevant endpoint libraries, precedent submissions, and a realistic timeline — before you've committed to anything.
No sales pitch. First call is a technical scoping session.
Response within one business day from a credentialed epidemiologist.
We'll send a complimentary study feasibility memo after the call.
RWE Study Design Checklist
8 critical checkpoints · PDF · Free
Research question & PICO framework defined
Data source fit-for-purpose assessment
Cohort entry criteria & index date logic
Covariate selection & confounding strategy
Endpoint definitions (primary, secondary, HEOR)
Statistical analysis plan (SAP) outline
Sensitivity & subgroup analysis pre-specification
Regulatory alignment check (FDA / HTA body)
Used by HEOR teams at 40+ pharma organizations
Not ready to talk?
Validate your protocol first.
The Signal RWE Study Design Checklist covers the eight decision points that determine whether your study will survive FDA or HTA scrutiny. Built from 120+ regulatory submissions.
120+
Submissions informed
14 wk
Median delivery
100%
Acceptance rate