Study Start-Up & Regulatory
Ethics submissions, SAHPRA notifications, site file preparation, and contract execution, managed with precision and speed.
40+
Studies delivered
GCP-Compliant · SAHPRA-Inspected · Pretoria, South Africa
A trusted clinical research partner, delivering high-quality trial execution.
Botho Ke Bontle Healthcare Services is a purpose-built clinical research centre partnered with 14 of the world's foremost pharmaceutical sponsors, with over a decade of protocol adherence, data integrity, and patient safety across Phase 1–4 trials.
Partnered with & delivered for
Pfizer
Moderna
Novo Nordisk
Roche
Sanofi
AstraZeneca
BioNTech
Seqirus
Who We Are
World-class research, rooted in the communities it serves.
Founded on the principle that Botho Ke Bontle, humanity is kindness, we began in Mamelodi in 2014 with a deliberate commitment to bringing clinical research access to populations historically excluded from pharmaceutical innovation.
Over a decade on, that founding commitment remains our ethical foundation. Botho Ke Bontle has grown from a community-based site into a recognised multi-sponsor research centre, operating a purpose-built facility equipped for Phase 1–4 trials across a broad spectrum of therapeutic areas.
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Purpose-built facility
Access-controlled pharmacy, full cold chain, and calibrated clinical equipment maintained to GCP standards.
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Inspection & audit ready
Successful SAHPRA inspections (2015, 2023) and sponsor audits by Pfizer and Novo Nordisk.
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Experienced site team
Led by a Principal Investigator with two decades of clinical research experience and a stable operational team.
"New drugs bring hope, and every participant deserves research conducted with dignity, safety, and scientific rigour."
The founding ethos of Botho Ke Bontle
What We Do
End-to-end clinical trial capabilities
From start-up and regulatory submission through to close-out and archiving, a complete site infrastructure that sponsors and CROs can rely on.
Investigational Product Management
Full cold-chain capability, 2–8 °C, −20 °C, −40 °C and −70 °C, with access-controlled pharmacy and continuous temperature monitoring.
Clinical Assessments
Calibrated 12-lead ECG, centrifuge, sphygmomanometry, pulse oximetry, and weight/height measurement to GCP standards.
Laboratory Coordination
Accredited Ampath laboratory at Wilgers Hospital, chest imaging via Radiology24, and emergency care through Life Wilgers Hospital.
Data & Source Documents
Audit-ready source documentation, sponsor EDC system support, and rigorous query-resolution practices.
Monitoring & Ethics Management
Dedicated monitor workspace, pre-visit preparation, and comprehensive ethics management, amendments, safety reporting, and renewals.
Proven Experience
Over a decade of sponsor confidence
The most reliable indicator of site quality is repeat engagement, and our sponsors return, study after study.
14
International sponsors
4
Studies currently active
5
Studies in start-up
Therapeutic Breadth
Experience across the areas that matter most
Vaccines, metabolic disease, respiratory medicine and beyond, spanning maternal, paediatric, and adult populations.
COVID-19 Treatment & Vaccines
RSV Vaccines
Obesity & Diabetes
Respiratory Medicine
Quality & Compliance
Held to the standards our sponsors expect
ICH-GCP E6(R3)
All studies conducted to international Good Clinical Practice standards.
SAHPRA Inspected
Regulatory compliance confirmed at inspection in 2015 and re-inspection in 2023.
NHREC Ethics
Protocols reviewed by a NHREC-registered SA Research Ethics Committee.
Current GCP Training
All key personnel maintain current GCP certification and protocol training.
Every trial we conduct depends on volunteers who choose to take part in research.
For Our Community
Take part in clinical research
Clinical trials give participants access to investigational treatments and close medical monitoring, while advancing medicine for everyone. If you are interested in taking part in a study at our Pretoria site, we would be glad to tell you what is involved.
Learn about participatingConsidering a site for your next study?
We welcome CROs and sponsors seeking a reliable, growth-oriented clinical research partner in South Africa.