Real World Evidence
Rif Research sets up and oversees non-interventional studies, post-authorisation safety studies and registries for biotech and pharma sponsors across the UK, Ireland and the EU. The same feasibility, regulatory and site activation discipline applied to clinical trials, so a real-world study opens on schedule and holds up to inspection. The sponsor keeps accountability. Rif Research takes ownership of the plan, the evidence and the result. Founder-led, with 19 years of global trial delivery across interventional and non-interventional studies.
What we deliver
Real-world studies lose time for operational reasons more often than scientific ones: classification settled late, ethics and data-protection routes mapped after country selection, data partners contracted without an oversight plan. Rif Research works at those three points.
Operational review of the protocol, country and site feasibility, ethics and competent authority routes where no clinical trial application applies, site contracting and activation planning for NIS, PASS and registry studies.
Founder track record: study start-up and site activation across interventional and non-interventional designs, Phase 1 to Phase 4.
Typical deliverables
feasibility plan, country route map, activation forecast, site contracting tracker.
Assessment of whether a study is interventional or non-interventional under Regulation (EU) No 536/2014 and the UK clinical trials regulations as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, with the consequences mapped before protocol sign-off. For post-authorisation safety studies, planning under GVP Module VIII, including registration in the HMA-EMA Catalogue of RWD studies. For UK non-interventional studies, HRA and HCRW Approval in England and Wales, with NHS Research Scotland and Health and Social Care Northern Ireland permissions where sites sit there. Data-protection basis documented for each country under UK GDPR, EU GDPR and national law.
Founder track record: strategic oversight of EU CTR submissions through CTIS, assessed by the HPRA and NREC-CT, accountable for submission strategy, risk identification and mitigation planning.
Typical deliverables
classification memo, regulatory route per country, submission and notification calendar, data-protection summary.
Selection and oversight of registries, electronic health record and claims-data providers, ePRO vendors and site networks. An oversight plan and risk register proportionate to the study, in line with ICH E6(R3) quality by design, so data provenance and sponsor accountability are clear from the first contract.
Founder track record: vendor and CRO deliverables, timelines and performance managed against protocol, SOPs and the monitoring plan, with variance escalated the week it appeared.
Typical deliverables
vendor oversight plan, risk register, data flow and provenance map, escalation pathway.
When a real-world study drifts, we find the cause, reset the critical path and put risk-based governance in place. Sponsor files prepared to withstand inspection, with CAPA delivery where needed.
Founder track record: a multi-country programme recovered from delayed start-up timelines, with the critical path re-mapped and risk-based governance put in place for the sponsor.
Typical deliverables
root cause review, reset critical path, governance framework, inspection readiness review.
Standards we work to
When to involve us
Classification and feasibility while the design can still change. The cheapest moment to fix a route problem.
Ethics, authority and data-protection routes mapped per country, with realistic activation dates.
Root cause, reset plan, named owners and dates, reported honestly.
Every engagement begins with a 15-minute introductory call.
Real-world study readiness review
A fixed-scope review of your study plan, protocol and vendor set-up, delivered as a written plan with owners and dates within 2 working days.
