Expert SAHPRA submissions, IRB and IEC ethics management, GCP training and CRA services — from Johannesburg to the continent.
Site support & monitoring across South Africa
Clinical research consultancy headquartered in Johannesburg, Gauteng — serving sponsors and sites across South Africa and the African continent.
Alpha CR Solutions is a Johannesburg-based clinical research consultancy founded on the principle that regulatory quality and operational efficiency are not competing priorities — they are the same goal.
We bring together expertise in SAHPRA regulatory affairs, ethics committee management, clinical monitoring and GCP training to provide sponsors and sites with a single, accountable partner across the full trial lifecycle.
Our SDR-first methodology means data integrity is built into every site engagement from day one — reducing audit findings, protecting subjects, and accelerating the path to clean data.
From first submission to final close-out, Alpha CR Solutions covers every regulatory and operational requirement of your South African clinical trial.
End-to-end management of SAHPRA Clinical Trial Applications, IRB submissions and site IEC management — with full query handling and authority liaison.
Study start-up, MTA and import/export permits, vendor assessments, source data and SOP development, and site set-up for naive and established sites.
Experienced Clinical Research Associates delivering source data review, site qualification, initiation, routine monitoring and close-out visits to ICH E6(R3) standards.
Training new CRAs through real-site shadowing and online simulations, competency assessment for CROs and sponsors, plus patient engagement and recruitment support.
ICH E6(R3) aligned Good Clinical Practice training delivered through our LMS and in-person sessions for sites, investigators, coordinators and pharmacists.
Clinical research software — our regulated Clinveo EDC, an IWRS/RTSM for randomisation, the Clinical Trial Patient Matcher, LMS development and custom dashboards.
We are not a generic CRO. We are a focused regulatory and clinical operations partner built specifically for the South African clinical research environment.
Source Data Review is built into our monitoring approach from site set-up, not added as an afterthought. Every site we manage is inspection-ready from day one.
We understand the SAHPRA submission process in detail — from CTA dossier structure to query management timelines — and plan your regulatory strategy accordingly.
One partner covering regulatory, ethics, monitoring and training means no handoff gaps, aligned timelines and consistent quality standards throughout your trial.
Solid tumours & haematology
HIV, TB, malaria, hepatitis
Hypertension & cardiac disease
Diabetes & metabolic disease
Central nervous system trials
Asthma, COPD & pulmonology
Preventive & therapeutic vaccines
Orphan indications & ATMPs