Study Start-Up & Regulatory
Ethics submissions, SAHPRA notifications, site file preparation, and contract execution, managed with precision and speed.
From study start-up and regulatory submission through to close-out and archiving, the people, processes, and equipment to execute Phase 1–4 trials to GCP standards.
Ethics submissions, SAHPRA notifications, site file preparation, and contract execution, managed with precision and speed.
Full cold-chain capability with access-controlled pharmacy and continuous temperature monitoring, protecting IP integrity at every stage.
Calibrated 12-lead ECG, centrifuge, sphygmomanometry, pulse oximetry, and weight/height measurement performed to GCP standards.
Accredited Ampath laboratory at Wilgers Hospital, chest imaging via Radiology24, and emergency care through Life Wilgers Hospital.
Audit-ready source documentation, sponsor EDC system support, and rigorous query-resolution practices.
A dedicated monitor workspace, thorough pre-visit preparation, and consistently high-quality monitoring visit outcomes.
Comprehensive ethics management, protocol amendments, safety reporting, annual renewals, and NHREC compliance.
Community relationships and structured retention protocols refined across 40+ trials and multiple cohorts.
Multilingual consent processes in English, Zulu, Sotho, and Tswana, ensuring genuine participant understanding.
Our purpose-built facility is engineered to safeguard investigational product, participant wellbeing, and protocol adherence, even under challenging infrastructure conditions.
Generator + inverter backup ensures uninterrupted operations and cold-chain protection.
Access-controlled pharmacy, secure consultation rooms, and continuous temperature monitoring.
Temperature logging across all storage tiers, safeguarding IP from receipt to dispensing.
A full complement of clinical and cold-chain equipment supports studies across our therapeutic areas.
Tell us about your study and we will share a detailed site feasibility overview. Reach our feasibility team directly at feasibilities@bothokebontle.co.za.