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Natural history studies
Characterise how a disease progresses without treatment, giving regulators a clear reference point to judge treatment effect.
Real-world evidence regulators accept.
Turn real-world data into submission-ready evidence, faster and at lower cost, with a clear line from data to decision. Backed by a track record of successful regulatory submissions built on real-world evidence for our partners.
Six ways real-world evidence strengthens a submission
External control arms
Build controls from real-world cohorts so single-arm trials have a credible comparison without a placebo group.
Supplementing randomised trials
Combine RWE with trial data to strengthen safety and effectiveness answers to specific regulatory questions.
Providing primary evidence
Use RWE as a core data source where a traditional trial is not feasible, ethical or fast enough.
Supporting new indications
Identify and prioritise new indications, and raise probability of success through integrated development strategy.
Supporting post-approval studies
Meet post-market commitments with ongoing, real-world safety and effectiveness monitoring.
Our formula for regulatory-grade RWE
We pair our proprietary platform with regulatory expertise to build an evidence strategy around your asset. Every plan starts from your questions, your endpoints and the data regulators will accept, never a template.
Collaborative discovery
We start with your team to map the challenge, the asset and the outcome you need, so the strategy is built on your reality, not a template.
Rapid evidence alignment
In days, InoviaIEP delivers an integrated evidence plan that aligns stakeholders, exposes the critical gaps and defines exactly what evidence your submission needs.
Swift data identification
We pinpoint the regulatory-grade real-world data to support your submission in minutes, not months.
RWE data analysis with InovaMine
InovaMine, our machine-learning platform for real-world data, turns that data into decision-ready insight, so you can act with confidence and strengthen the programme.
Regulatory expertise
Our medical team guides you through the regulatory process, spotting issues early and keeping the path to approval clear.
Try our free RWE study designer
Design real-world evidence studies in minutes. Map the assessment windows, define your cohort and pressure-test the design before you commit.
Latest RWE insights
What regulatory-grade RWE really means
The bar real-world evidence has to clear before regulators will lean on it, and how to hit it.
How RWE accelerates biotech investment
Why real-world evidence de-risks an asset and helps fundraising biotechs move faster.
Post-marketing commitments that do more than tick the box
Designing a post-approval study that earns its place instead of just satisfying a requirement.
Put real-world evidence to work on your programme
Download the RWE regulatory briefing template
Related reading: What does regulatory grade RWE mean?
Free resources: the RWE for regulatory submissions hub
Guides, briefs and the RWE Regulatory Briefing pack: study design, data quality and the submission strategy regulators accept. Free, no pitch.