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Clinical trial consultancy · UK, Ireland and Europe

Complex study start-up. Independent sponsor oversight.

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.

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01

Study start-up acceleration

Country and site feasibility, activation planning, bottleneck analysis and delivery oversight from first site selected to first participant in.

Founder track record: first participant in within 8 weeks on accelerated vaccine programmes.

02

Regulatory submissions and readiness

Clinical trial applications across the UK, Ireland and other EU Member States. UK: combined MHRA and research ethics committee review under the reformed UK regulations. EU: submission strategy via CTIS under the EU CTR, 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.

Founder track record: strategic oversight of Irish EU CTR submissions through CTIS, assessed by the HPRA and NREC-CT, accountable for submission strategy, risk identification and mitigation planning.

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03

Start-up rescue and delivery advisory

When activation timelines drift, we find the cause, reset the critical path and restore sponsor confidence. We also provide risk-based governance, vendor oversight and start-up process design for sponsors building or rebuilding capability.

Founder track record: a multi-country programme recovered from severely delayed start-up timelines.

04

Quality risk management and inspection readiness

Risk identification, assessment and mitigation across studies, countries, vendors and sites, in line with ICH E6(R3). Risk registers, escalation pathways, centralised monitoring review, CAPA delivery and inspection preparation, so your teams see risks early and act before they reach the critical path.

Founder track record: start-up subject matter expert through an MHRA inspection, with CAPA delivery at country and study level.

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Reduce the risk of start-up delays, submission rejections and critical path drift. We review your start-up milestones, identify regulatory and site activation bottlenecks, and deliver a written recovery plan with defined owners and dates.

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Biotechs

Senior start-up leadership without a permanent hire, from first country selection to site activation.

Sponsors

Independent oversight of CRO start-up delivery, submission strategy and inspection readiness.

How we engage

Three ways of working, each with defined scope, named deliverables and agreed dates.

Start-up diagnostic

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.

Project engagement

Defined deliverables for a study or programme, from feasibility and submission strategy to site activation and inspection readiness.

Fractional start-up leadership

Senior oversight on a retained basis for sponsors and biotechs without a permanent hire.

Every engagement begins with a 15-minute introductory call.

How it works

  1. 01

    Introductory call

    15 minutes to understand your study, countries and dates.

  2. 02

    Proposal

    Written scope, deliverables, timeline and fee basis, usually within three working days.

  3. 03

    Delivery

    Reported against agreed milestones, with early escalation of risk.

  4. 04

    Handover

    Documented outputs and a clear route for your team to continue.

Scientist working in a regulated clinical laboratory

Coverage

Phase 1 to Phase 4

Depth where complex studies demand it.

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 experience

Clear commitments. Disciplined delivery.

Our values spell our name

RIGOUR

GCP-aligned delivery built on ICH E6(R3) quality by design and critical-to-quality thinking, to help prepare your trial for regulatory inspection.

INTEGRITY

Participant protection, data integrity and client confidentiality come first. We report progress honestly, including when the news is unwelcome.

FORESIGHT

Risk-proportionate planning, supported by AI-assisted regulatory intelligence, that anticipates regulatory and operational risks before first participant in.

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. Qualified in pharmacy in Spain, she holds an MSc in Clinical Trial Monitoring and Management.

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Planning a study, or recovering one? Start a conversation.

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