Clinical trial consultancy · UK, Ireland and Europe
Rif Research is a founder-led consultancy specialising in study start-up, regulatory readiness and delivery recovery for emerging biotech and pharma sponsors. We lead the critical path from final protocol to first participant in across complex oncology, rare diseases and advanced therapies, providing the hands-on oversight needed to keep global programmes on schedule. Founder-led, with 19 years of global trial delivery.
Start a conversationWhat we deliver
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.
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.
Get the submission readiness checklistIndependent 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.
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.
Start-up diagnostic
Avoid start-up delays, submission rejections and critical path drift. We review your start-up milestones, identify regulatory and site activation bottlenecks, and deliver a clear recovery roadmap with defined owners and dates.
Who we support
Senior start-up and regulatory leadership on demand, from country allocation and CTIS dossier strategy to site contracting and first participant in, without the overhead of a permanent team.
Objective scrutiny of CRO start-up milestones, vendor contracts and activation metrics, ensuring sponsor accountability under ICH E6(R3) without duplicating CRO operational headcount.
Rapid diagnostics and critical path resets when site activation stalls, RFIs threaten submission deadlines, or national approvals drift.
Three ways of working, each with defined scope, named deliverables and agreed dates.
A fixed-scope review of your start-up plan, delivered as a written recovery plan with owners and dates. The fastest way to find out where a timeline is slipping.
Defined deliverables for a study or programme, from feasibility and submission strategy to site activation and inspection readiness.
Senior oversight on a retained basis for sponsors and biotechs without a permanent hire.
Every engagement begins with a 15-minute introductory call.
15 minutes to understand your study, countries and dates.
Written scope, deliverables, timeline and fee basis, usually within three working days.
Reported against agreed milestones, with early escalation of risk.
Documented outputs and a clear route for your team to continue.
Coverage
Phase 1 to Phase 4
Therapeutic experience
Oncology, haemato-oncology, rare diseases, respiratory, inflammation, cardiovascular and paediatrics, with experience in ATMP and gene therapy studies, including GMO trial applications. Phase 1 to Phase 4, interventional and non-interventional.
Explore our experienceHow we work
Our values spell our name
GCP-aligned delivery built on ICH E6(R3) quality by design and critical-to-quality thinking, so your trial is prepared for regulatory inspection.
Participant protection, data integrity and client confidentiality come first. We report progress honestly, including when the news is unwelcome.
Risk-proportionate planning, supported by AI-assisted regulatory intelligence, that anticipates regulatory and operational risks before first participant in.
About the founder
Rif Research was founded and is led by Afi Ghazouani, a study start-up manager with 19 years of clinical research and global trial delivery experience across sponsor and CRO environments. A pharmacist by training, she holds an MSc in Clinical Trial Monitoring and Management.
Afi leads study start-up as a strategic delivery function, from core document development and global feasibility through regulatory and ethics approvals, site contracting, activation, first participant in and last site activated. Her responsibilities have included country and investigator selection, submission strategy, informed consent document governance, contract and budget oversight, risk mitigation and site activation acceleration.
Her experience spans 45 countries and Phase I to Phase IV clinical trials across oncology, haemato-oncology, rare diseases, paediatrics, respiratory disease and early-phase development, including accelerated COVID-19 programmes.
Since 2022, Afi has directed EU Clinical Trials Regulation and Clinical Trials Information System delivery. Her experience includes strategic oversight of Part I and Part II submission packages, responses to requests for information, substantial modifications and cross-functional delivery throughout the EU CTR transition. She identifies regulatory and operational risks early, establishes proportionate mitigation plans and protects committed start-up milestones.
Afi has managed trials in the UK and Ireland since 2012. She monitors evolving legislation and guidance from the EMA, MHRA, HRA and relevant Irish authorities, translating regulatory change into operational readiness, training and process improvement. Her experience covers medicinal products, medical devices and combination products.
Her site-management expertise extends across the clinical trial lifecycle, including site partnership development, evaluation and selection, regulatory and ethics submissions, contract and budget governance, activation, investigator and site-team training, monitoring oversight, data-quality governance, and audit and inspection readiness. She builds trusted relationships with principal investigators, key opinion leaders, sites and cross-functional delivery teams.
Afi is a subject-matter expert in study start-up, site activation and MHRA inspection readiness. She works professionally in English, Spanish and French.
Whether your programme requires start-up strategy, regulatory oversight, activation acceleration or timeline recovery, Rif Research provides senior, practical support focused on clear decisions, controlled risk and measurable delivery.
Start a conversation about your study or programme.
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