Non-Interventional Studies (NIS)
Observational research with no change to clinical practice.
Observational Studies & Real-World Evidence
Real-World Evidence That Strengthens Your Development Strategy
Real-world evidence has moved from a post-market afterthought to an early-development tool. Regulators, payers and development teams now use RWE to contextualise Phase I–II findings, justify external comparator arms, build natural-history baselines for rare disease, and support submissions before pivotal trials begin.
We provide senior-led operational support for observational and RWE programmes linked to early-phase development, with the same governance discipline and data-quality standards we bring to interventional trials.
Programme types we support
Six programme types, one operational standard
Natural History Studies & Patient Registries
Rare and ultra-rare disease populations.
Longitudinal Follow-Up
Extended safety and efficacy data after Phase I–II.
External Comparator Programmes
Real-world data to support single-arm submissions.
Post-Authorisation Safety Studies (PASS)
And post-marketing surveillance.
HTA-ready RWE
Aligned with NICE, HAS and G-BA requirements.
Where we add value
Observational research rewards operational discipline.
Without randomisation or protocol-mandated procedures, the work shifts into the data and the sites, and that is exactly where we focus: standardised data collection across diverse healthcare systems, site-engagement that keeps investigators motivated, and governance that holds data quality without the scaffolding of an IND/CTA framework.
How we work
An embedded operational partner, tailored to complexity and reach
We embed as an operational partner to biotech sponsors, academic groups and CRO teams running RWE programmes, and tailor oversight to the complexity and reach of each, from single-country natural-history studies to multi-regional, multi-year initiatives.
Discuss your observational programme
Tell us about your RWE or observational project. A senior member of our team will respond within two business days.