Advanced Biometrics, Real-World Evidence & Clinical Data Sciences
Stage Analytics helps pharmaceutical, biotechnology, medical device, and healthcare organizations transform clinical and real-world data into regulatory-grade evidence through biostatistics, statistical programming, HEOR, market access research, observational studies, and advanced analytics.
Submission-ready deliverables
- SDTM
- ADaM
- Define.xml
- cSDRG and ADRG
- NDA
- BLA
- MAA
- IND
Who we are
Our biostatistics and clinical data services bring together biostatistics, statistical programming and clinical data management with real-world evidence, HEOR and market access research, so that evidence is planned, generated and communicated by one team.
- 7practice areas
- 24specialist services
- 1connected team
One teamplanned, generated, communicated
Our services
From statistical design to HTA submissions, our services cover each stage of evidence generation.
Try
Biometrics & Statistical Sciences7
- Biostatistical ConsultingProtocol statistical design, sample size, endpoint strategy, adaptive and Bayesian designs, and regulatory interactions.
- Statistical ProgrammingSAS, R and Python programming, QC programming and automation solutions.
- CDISC SDTM & ADaMSDTM mapping, ADaM development, Define.xml, cSDRG and ADRG, with regulatory eSubmissions support.
- Tables, Listings & Figures (TLFs)Efficacy and safety TLFs, PK/PD outputs and ISS/ISE support.
- Survival AnalysisTime-to-event analysis connected to endpoint strategy, efficacy outputs and partitioned survival models.
- Causal InferencePropensity score matching, IPTW, IV methods and doubly robust models for observational data.
- Statistical Analysis PlansSAPs for clinical and observational studies, built on sound statistical design.
Clinical Data Sciences3
- Clinical Data ManagementCRF design, query management, data cleaning, reconciliation and database lock.
- EDC Development & ValidationDatabase build, UAT, edit checks and validation testing on Medidata Rave, Veeva Vault EDC, REDCap and OpenClinica.
- Data Engineering & IntegrationETL pipelines, data warehouses, common data models and research-ready datasets.
Real-World Evidence5
- Real-World Evidence Strategy & GenerationEvidence gap assessment and planning through study design, analytics execution and publication support.
- Real-World Data Assessment & FeasibilityClaims and EHR feasibility, registry evaluation, data source selection and cohort evaluations.
- Observational Study Design & ExecutionRetrospective and prospective cohort, case-control, cross-sectional and registry-based studies.
- Comparative Effectiveness ResearchWhich treatment performs best, which population benefits most, and the impact on healthcare utilization.
- Patient Journey AnalyticsDiagnosis pathways, treatment patterns, switching behavior, adherence, persistence and disease progression.
HEOR & Market Access5
- Health Economics & Outcomes Research (HEOR)Burden and cost of illness, economic evaluation, outcomes research and utility research.
- Market Access StrategyValue strategy, evidence planning, payer research, pricing strategy and access optimization.
- Cost-Effectiveness ModelingMarkov, decision tree, partitioned survival and microsimulation models producing QALYs, ICERs and cost-utility results.
- Budget Impact AnalysisEligible population, treatment uptake, healthcare costs and resource utilization.
- HTA Support & Dossier DevelopmentValue dossiers, HTA submissions, economic models and supporting evidence packages.
No service matches that search. Ask our team and we will point you to the right specialists.
Across the product lifecycle
Clinical trials, biometrics, data management, regulatory submissions, real-world evidence, HEOR and market access, delivered by one team, with methods and data that carry from one stage to the next.
- Clinical trials
- Biometrics
- Data management
- Regulatory submissions
- Real-world evidence
- HEOR
- Market access
Submissions, platforms and data
The standards, platforms and data sources our biometrics, data management and real-world evidence teams work with.
Regulatory submissions
EDC platforms
Real-world data sources
What we doNDA, BLA, MAA and IND submissions, with FDA and EMA submission support.
What we doDatabase build, UAT, edit checks and validation testing.
What we doClaims and EHR feasibility, registry evaluation and cohort evaluations.
Covers
- SDTM and ADaM datasets
- Define.xml
- cSDRG and ADRG
- NDA, BLA, MAA, IND
Covers
- Medidata Rave
- Veeva Vault EDC
- REDCap
- OpenClinica
Covers
- IQVIA, Komodo
- MarketScan, Optum
- Flatiron, Truven
- Symphony
How we work
Four habits that run through every study, dataset and deliverable.
Design first
Statistical design, endpoints and sample size are settled early, so every later dataset and output has a clear basis.
Built to standards
CDISC SDTM and ADaM, Define.xml, cSDRG and ADRG, with submission compliance considered from the start.
Quality-controlled
QC programming, validation testing, reconciliation and edit checks are part of the workflow, not an afterthought.
Connected across the lifecycle
Methods and data carry from clinical trials into real-world evidence, HEOR and market access.
Industries we support
Pharmaceutical, biotechnology, medical device and healthcare organizations.
Frequently asked questions
Short answers about our biometrics, data and evidence services.
What does Stage Analytics do?
We help pharmaceutical, biotechnology, medical device and healthcare organizations turn clinical and real-world data into regulatory-grade evidence.
Which services do you offer?
Biometrics and statistical sciences, clinical data sciences, real-world evidence, HEOR and market access, evidence synthesis, scientific communications and clinical operations.
Do you prepare CDISC datasets for regulatory submissions?
Yes. We prepare SDTM and ADaM datasets with Define.xml, cSDRG and ADRG for NDA, BLA, MAA and IND submissions.
Which EDC platforms do you work with?
Medidata Rave, Veeva Vault EDC, REDCap and OpenClinica, including database build, UAT, edit checks and validation testing.
Which real-world data sources do you assess?
Claims, EHR and registry data, including sources such as IQVIA, Komodo, MarketScan, Optum, Flatiron, Truven and Symphony.
Have a different question? Contact our team
Contact our team
Tell us where you are in the product lifecycle and we will outline how our biometrics, data and evidence teams can support it.
Start with what you need