A clinical research consultancy built from deep field experience — founded in Johannesburg to serve South African sponsors, sites and the broader African clinical research ecosystem.
Alpha CR Solutions was founded on the conviction that quality clinical research in South Africa is not a constraint — it is a competitive advantage. Sites that operate to the highest regulatory and data quality standards enroll faster, retain more participants, and produce cleaner data.
We exist to make that standard accessible — to emerging biotechs navigating SAHPRA for the first time, to established sponsors expanding into African markets, and to investigative sites building the capacity to host more complex studies.
Our work spans the full regulatory and operational lifecycle: from protocol development and ethics submissions to site monitoring, GCP training and clinical trial closure.
"Quality in clinical research is not about compliance for its own sake — it is about protecting people and producing evidence that can be trusted."
Alpha CR Solutions Leadership TeamThree principles guide every engagement we take on — from a single GCP training day to a multi-site Phase III programme.
Source data integrity is built into every site engagement before the first patient is screened. We develop source documents with sites at set-up, not retrospectively — because data errors are always cheaper to prevent than to correct.
We do not work for you — we work with you. Our team integrates directly into your study operations, aligns to your timelines, and takes shared accountability for the quality of every submission and site visit report.
We treat regulatory and ethics compliance as the foundation of everything else — not as a final checkpoint. Inspection readiness is built into our standard operating procedures, not prepared at the last minute.
Alpha CR Solutions is staffed by experienced Clinical Research Associates and regulatory specialists with hands-on backgrounds across multiple therapeutic areas and South African regulatory environments.
Our CRAs bring direct site monitoring experience across Phase I–IV trials — trained in SDR methodology, risk-based monitoring and ICH E6(R3) compliant documentation practices.
Specialists with direct experience in SAHPRA Clinical Trial Applications, IRB and IEC ethics submissions, and ongoing regulatory maintenance — covering multiple therapeutic areas and trial phases.
Certified GCP trainers delivering ICH E6(R3) aligned training contextualised for the South African research environment — for investigators, coordinators, pharmacists and data managers.
Every deliverable — submission, monitoring report, training session — is held to a standard we would be comfortable defending in front of a SAHPRA inspector or sponsor auditor.
Clinical research exists to generate evidence that improves human health. The rights, safety and wellbeing of trial participants are never subordinate to timelines, budgets or data requirements.
We believe South Africa and the broader African continent have the scientific infrastructure to host world-class clinical trials. Our work supports that vision by raising the quality standard one site, one submission, one training at a time.