What we deliver
Rif Research works at study start-up: feasibility, site selection, site activation, clinical trial applications and the regulatory groundwork that determines whether a study opens on schedule or slips a quarter.
Feasibility assessment, site selection governance and critical path acceleration for complex oncology, haemato-oncology, rare-disease and novel modality programmes, managing the path from protocol finalisation to first participant in.
Progressed from final protocol to first participant in within eight weeks on an accelerated COVID-19 vaccine programme.
feasibility plan, activation forecast, critical path map.
Clinical trial applications across the UK, Ireland and EU Member States: MHRA combined review under the reformed UK regulations, and EU CTR submission strategy via CTIS, including Part I and Part II dossier governance, substantial modifications and RFI response management. In Ireland, the HPRA and NREC-CT assess applications submitted through CTIS.
Strategic oversight of Irish EU CTR submissions through CTIS, assessed by the HPRA and NREC-CT, protecting committed start-up milestones.
submission strategy, country sequencing, document checklist, submission tracker.
Independent start-up governance for sponsors managing outsourced CRO delivery. When activation timelines drift or site contracting stalls, we identify the root cause, reset the critical path and re-establish delivery momentum.
A multi-country programme recovered from severely delayed start-up timelines.
root cause review, reset critical path, recovery plan, governance framework, vendor oversight plan.
ICH E6(R3)-aligned risk identification, vendor governance, risk registers and CAPA delivery, preparing sponsor and site teams for MHRA and European regulatory audits before issues reach the critical path.
Start-up subject matter expert through a five-day MHRA inspection, with CAPA delivery at country and study level.
risk register, escalation pathway, CAPA plan, inspection readiness review.
Start-up diagnostic
Not sure where your timeline is slipping? We review your start-up plan, identify the bottlenecks and deliver a written recovery plan with clear owners and dates.
Ask about the diagnosticstart-up diagnostic, defined project, advisory retainer, interim leadership, training workshops.
