Global clinical trial leadership.

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.

Afi leads study start-up as a strategic delivery function: from core document development and global feasibility, through regulatory and ethics approvals, site contracting and activation, to first participant in and last site activated. Those responsibilities have included country and investigator selection, submission strategy, informed consent document governance, contract and budget oversight, risk mitigation and accelerating site activation.

Her experience spans Phase 1 to Phase 4 trials across the UK, Europe, Latin America, Africa, the Middle East, Asia-Pacific and North America, including early-phase development and accelerated COVID-19 programmes. Therapeutic areas include oncology, haemato-oncology, rare diseases, paediatrics and respiratory disease. That experience includes medicinal products, medical devices and combination products.

Since 2022, Afi has directed delivery under the EU Clinical Trials Regulation (EU CTR) through the Clinical Trials Information System (CTIS). That work has included strategic oversight of Part I and Part II application dossiers, responses to requests for information (RFIs), 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 UK, EU and Irish clinical trial legislation, and guidance from the MHRA, HRA, EMA, HPRA and NREC-CT, translating regulatory change into operational readiness, training and process improvement.

Her site management expertise runs across the full clinical trial lifecycle. It covers site evaluation, selection and partnership development; submissions and contracting; investigator and site team training; oversight of monitoring; data quality governance; and audit and inspection readiness. She builds trusted relationships with principal investigators, key opinion leaders, sites and cross-functional teams.

Her delivery record includes 32 UK sites activated in 10 weeks, first participant in within eight weeks on accelerated programmes, the transition of 15 EU trials to the January 2025 EU CTR deadline, and the recovery of a multi-country programme from severely delayed start-up.

Afi is a subject matter expert in study start-up, site activation and MHRA GCP 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.