Home/Capabilities
What We Do

A complete site infrastructure, ready for your protocol.

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.

Clinical Research Capabilities

Full-service trial execution

Study Start-Up & Regulatory

Ethics submissions, SAHPRA notifications, site file preparation, and contract execution, managed with precision and speed.

Investigational Product Management

Full cold-chain capability with access-controlled pharmacy and continuous temperature monitoring, protecting IP integrity at every stage.

Clinical Assessments

Calibrated 12-lead ECG, centrifuge, sphygmomanometry, pulse oximetry, and weight/height measurement performed 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 Visit Support

A dedicated monitor workspace, thorough pre-visit preparation, and consistently high-quality monitoring visit outcomes.

Ethics & IRB Management

Comprehensive ethics management, protocol amendments, safety reporting, annual renewals, and NHREC compliance.

Patient Recruitment & Retention

Community relationships and structured retention protocols refined across 40+ trials and multiple cohorts.

Informed Consent

Multilingual consent processes in English, Zulu, Sotho, and Tswana, ensuring genuine participant understanding.

Facility & Infrastructure

Built for continuity, secured for integrity

Our purpose-built facility is engineered to safeguard investigational product, participant wellbeing, and protocol adherence, even under challenging infrastructure conditions.

  • Power resilience

    Generator + inverter backup ensures uninterrupted operations and cold-chain protection.

  • Security & access control

    Access-controlled pharmacy, secure consultation rooms, and continuous temperature monitoring.

  • Continuous cold-chain monitoring

    Temperature logging across all storage tiers, safeguarding IP from receipt to dispensing.

Facility at a glance

Temp-controlled IP storage Generator + inverter backup Access-controlled pharmacy Continuous temperature monitoring Secure consultation rooms Dedicated monitor workspace Ampath laboratory access Chest imaging, Radiology24 Emergency trolley on-site

Local support network

Emergency care
Life Wilgers Hospital
Laboratory
Ampath, Wilgers Hospital (accredited)
Chest imaging
Radiology24 at Wilgers
Pharmacy
On-site, access-controlled, pharmacist dispensing
Oncology
Curo Oncology, Eugene Marais Hospital
Site Equipment

Calibrated, maintained, and audit-ready

A full complement of clinical and cold-chain equipment supports studies across our therapeutic areas.

Cold Chain Storage

  • ·Fridges (2–8 °C) ×2
  • ·Freezer −20 °C
  • ·Freezer −40 °C
  • ·Freezers −70 °C ×3

Diagnostic

  • ·Calibrated 12-lead ECG
  • ·Defibrillator
  • ·Calibrated centrifuge
  • ·Sphygmomanometer & pulse oximeter

Patient Assessment

  • ·Weight scale (≥250 kg)
  • ·Calibrated baby scale
  • ·Height scale (6–230 cm)

Emergency

  • ·Emergency trolley
  • ·Emergency drug kit (access-controlled)
  • ·Rapid-response protocols

Power Resilience

  • ·Generator backup
  • ·Inverter backup
  • ·Uninterrupted cold-chain protection

Security

  • ·Access-controlled pharmacy
  • ·Secure consultation rooms
  • ·Continuous temperature monitoring

Have a protocol in mind?

Tell us about your study and we will share a detailed site feasibility overview. Reach our feasibility team directly at feasibilities@bothokebontle.co.za.