Market Access · RWE
Evidence After
Approval.
RWE study design, data sourcing, and regulatory-grade analysis that answers the questions payers and regulators need answered after approval.
Pre-Specified
Overview
RWE Built to Regulatory Standard
Real world evidence pharma programmes answer the question that clinical trials are not designed to address: how does this therapy perform in the patients, settings, and timeframes that matter to payers and prescribing physicians? RWE strategy services at Vigilare Biopharma cover the full evidence generation cycle — from initial evidence planning through study design, data access, analysis, and regulatory-grade reporting. We build studies that hold up to the methodological scrutiny of FDA, EMA, and sophisticated payer technical reviewers. The most common RWE failure is not analytical — it is a study that cannot answer its own research question because the data source does not contain the right variables. We assess data sources against research questions before any study design is finalised.
- Research-question-first RWE study design
- Pre-specified, regulatory-grade protocols
- EHR, claims and registry data access
- FDA & EMA submission-ready packages
What We Deliver
Capabilities Across Every Stage
Three integrated disciplines, delivered by senior specialists as one accountable programme.
RWE Study Design
RWE study design at Vigilare Biopharma begins with the research question specifically framed in terms of the population, intervention, comparator, outcome, and timeframe that the payer or regulatory body requires. RWE consulting services cover cohort studies, case-control designs, registry-based analyses, and interrupted time series — each selected for methodological appropriateness. Observational studies pharma experience means we understand the confounding structures typical to different therapeutic areas and select analytical approaches — propensity score matching, instrumental variable analysis, target trial emulation — that produce credible causal inference from observational data. Real world data pharma sourcing is assessed rigorously before any study begins.
Data Sourcing & Analysis
Real world data analysis is conducted to pre-specified protocols — the same pre-specification discipline applied in randomised trials is applied in observational studies, because the absence of pre-specification is the most common criticism regulatory and payer reviewers raise. Patient outcomes data extracted from electronic health records, claims databases, and disease registries is processed through validated data transformation pipelines with full audit trail documentation. Outcomes research RWE methodology documentation covers every analytical decision in a format that enables independent replication and regulatory review.
Post-Approval Evidence
Post marketing evidence generation serves multiple stakeholder audiences: payers requiring effectiveness evidence for formulary maintenance, regulators requesting post-approval safety monitoring, and prescribers seeking comparative effectiveness data. RWE regulatory support for FDA Real-World Evidence Framework submissions and EMA post-authorisation study requirements demands methodological rigour equivalent to that applied in interventional trials. Market access evidence generated through RWE programmes strengthens reimbursement positions and supports outcomes-based contract negotiations. For sponsors requiring global RWE services USA EU UK in a coordinated evidence programme, we access data sources across all major markets — real world data consulting worldwide.
FDA·EMAGrade Packages
4Global Regions
Multi-Source Data
ISO 90012015 Quality System
Key Deliverables
What You Receive
Tangible, submission-ready outputs — not status updates.
RWE Study Protocol
Pre-specified, methodologically justified protocol aligned with regulatory and payer standards.
Data Source Assessment
Systematic evaluation of candidate data sources against the research question requirements.
RWE Analysis Report
Complete report including primary analysis, pre-specified sensitivity analyses, and limitations assessment.
Regulatory-Grade Package
Analysis documentation meeting FDA and EMA standards for regulatory submission with all supporting files.
Why Vigilare
Why Sponsors Choose Vigilare
What sets this engagement apart from a generic vendor.
Pre-Specified Protocols
Pre-specified study protocols as standard for all RWE studies — the same discipline applied in randomised trials, eliminating the credibility risk that post-hoc analytical decisions create.
Multi-Source Data Access
Multi-source data access across commercial and Medicare claims in the USA, national health registries in Scandinavia, Germany, and the Netherlands, and disease-specific registries in the UK and Australia.
Regulatory-Grade Packages
Regulatory-grade RWE package construction — analysis code version-controlled, outputs traceable to source datasets, and documentation structured to meet FDA and EMA electronic submission standards.
Cross-Stakeholder Design
Cross-stakeholder evidence design — studies simultaneously satisfying payer data requirements, regulatory post-approval commitments, and scientific publication objectives.
Who We Work With
Configured to Your Model
We engage differently depending on the function you already have in place.
Post-Launch Pharma Brands
Challenge
Facing payer requests for real-world evidence to support continued reimbursement
How We Help
RWE studies satisfying payer data requirements while generating commercially useful comparative effectiveness evidence.
Label Extension Candidates
Challenge
Seeking to expand indications using post-approval real-world data where additional RCTs are not feasible
How We Help
Regulatory-grade RWE studies meeting FDA or EMA standards for label extension submissions.
Outcomes-Based Contract Sponsors
Challenge
Need to demonstrate outcomes defined in a managed access or risk-sharing agreement
How We Help
Data collection frameworks aligned to contract outcomes with analysis packages meeting payer reporting requirements.
FAQs
Real-World Evidence, Answered.
01
What is real world evidence in pharma?
Real world evidence (RWE) in pharma refers to clinical evidence about a therapy's usage, effectiveness, and safety derived from analysis of real-world data collected outside randomised controlled trials. Sources include electronic health records, insurance claims databases, disease registries, and patient-reported data. RWE answers questions about how therapies perform in routine clinical practice, in patient populations broader than those enrolled in trials, and over timeframes longer than most clinical studies.
02
How is RWE used for approvals?
FDA and EMA have established frameworks for using real-world evidence to support regulatory decisions. RWE can support approval of new indications, fulfil post-approval study commitments, contribute to safety signal evaluation, and in some cases provide primary evidence for approval in conditions where — randomised trials are not feasible. The evidentiary standard for regulatory-grade RWE is high — requiring pre-specified protocols, robust confounding control, and transparent reporting.
Related Services
Complete the Access Strategy
Bundle this with the wider evidence and access programme — coordinated from one team.
Ready to generate RWE?
Speak to our team about your programme requirements. We respond within one business day.