We deliver specialized clinical research solutions for pharmaceutical, biotech, and MedTech companies conducting studies in Saudi Arabia.
From site feasibility and contracting to regulatory approvals, patient recruitment, monitoring, and compliant safety reporting. We ensure every trial phase meets SFDA requirements and Good Clinical Practice (GCP) standards.
With deep local insight, a strong investigator network, and proven regulatory expertise, we help global sponsors run efficient, compliant, and patient-centric trials in the Kingdom.
SFDA Compliant
In-Country CRA
Strong Sites Network
Seamless Sponsor Integrations
From Feasibility to Contracting
Site Management
We handle every stage of site setup, including identifying, evaluating, and contracting with high-performing investigators and study sites to ensure readiness and compliance from day one.
- Comprehensive feasibility analysis across therapeutic areas
- Investigator profiling based on capacity and regulatory track record
- Evaluation of infrastructure, patient pool, and SFDA preparedness
- Strategic feasibility reporting to support decisions
- Contract and budget negotiations with selected sites
- GCP-compliant review of site agreements
- Alignment with sponsor SOPs and local legal frameworks
Fast, Compliant Trial Launches
CTA & Regulatory Submissions
Our regulatory team ensures your study meets all SFDA and ethics requirements for a smooth startup.
- Preparation and submission of Clinical Trial Applications (CTA) to SFDA
- Coordination with Institutional Review Boards (IRBs) and ethics committees
- GCP-compliant review of trial documentation
- Import/export permit facilitation and regulatory consulting
Culturally Aligned Enrollment Strategies
Patient Recruitment & Retention
We design recruitment plans tailored to Saudi Arabian and Middle Eastern demographics, ethics, and healthcare realities, ensuring both enrollment speed and retention.
- Pre-screening & eligibility verification
- Community-based outreach programs
- Retention strategies to maintain participant adherence
- Continuous performance monitoring and adaptation
Your Study, Seamlessly Coordinated
Clinical Project Management
Our project managers keep your trial on schedule, within budget, and in compliance with all requirements.
- Full-lifecycle project planning and timeline control
- Sponsor and vendor coordination
- Risk mitigation planning and contingency execution
- Regular milestone reviews and reporting
Quality-Driven Trial Execution
Clinical Oversight & Monitoring
We ensure consistent oversight through experienced CRAs and modern monitoring strategies.
- Site initiation, interim, and closeout visits (on-site & remote)
- Source Data Verification (SDV) and protocol compliance checks
- Risk-based monitoring to optimize resources
- Real-time issue resolution and CAPA follow-up
Reliable Data. Compliant Safety Reporting.
Data Management & Pharmacovigilance
We protect the integrity of your data and ensure complete alignment with SFDA safety reporting requirements.
- Trial Master File (TMF) setup and maintenance
- SAE & SUSAR reporting within SFDA timelines
- Data reconciliation and cleaning
- Pharmacovigilance signal detection and reporting oversight