Research and Community
Our Commitment to healing our communities is forever. Below is a list of Research and Community projects we have lead.
A Revolution in HIV Prevention: Dr. Moraba Leads Phase 3 Trial of Long-Acting Lenacapavir
Adherence to daily pills is a major challenge for HIV prevention. Dr. Sehulong Robert Moraba…
A Historic Step Forward: Dr. Moraba Contributes to Phase 3 Trial of Promising TB Vaccine
Tuberculosis remains one of the world’s deadliest infectious diseases. The M72/AS01E vaccine candidate has emerged as one…
Discover Our Medical Research Services
Clinical Trial Operations & Site Management
Clinical Trial Site Leadership & Directorship: Full operational management of a clinical research site, including staffing, SOP development, and quality systems.
Principal & Sub-Investigator Services: Serving as the responsible study physician for Phase I-IV clinical trials across multiple therapeutic areas (especially Infectious Diseases: HIV, TB, RSV, Vaccines).
Site Feasibility & Activation: Assessing a site’s capability to conduct specific trials, followed by leading the activation process (regulatory submissions, clinic setup, training).
Regulatory & Ethics Compliance Management: Ensuring adherence to SAHPRA, GCP, protocol-specific requirements, and maintaining all essential regulatory documentation.
Clinical Quality Assurance (CQA) & Auditing: Conducting internal audits of clinical trial processes and data to ensure readiness for sponsor and regulatory inspections.
Clinical Research Services
Protocol Implementation & Study Coordination: Managing all day-to-day aspects of a clinical trial at the site level, from participant screening to close-out.
Participant Recruitment & Retention Strategy: Leveraging community engagement experience to design and implement effective strategies for diverse populations.
Informed Consent Process Oversight: Ensuring ethical and comprehensive participant consenting, a critical skill noted in his trial roles.
Investigational Product (IP) Management: Oversight of the storage, prescription, dispensing, and accountability of trial drugs/vaccines.
Clinical Trial Safety Monitoring & Pharmacovigilance: Performing safety assessments, managing adverse events, and ensuring timely reporting.
Capacity Building & Training
GCP & Research Ethics Training: Certified to provide training to research staff, nurses, and investigators on international and local ethical research standards.
Clinical Research Staff Mentorship & Training: Developing and delivering training programs for research nurses, coordinators, and data capture staff.
TB/HIV Clinical Mentorship for Healthcare Workers: Building clinical capacity for nurses and clinicians in public health and primary care settings.
Trial-Specific Procedure Training: Training site staff on complex trial protocols, laboratory procedures, and data collection tools.
Scientific & Medical Leadership
Clinical Trial Design & Protocol Development Consultation: Providing input on protocol feasibility, especially for trials in African settings and vulnerable populations.
Medical Monitoring & Safety Review: Serving as an independent medical monitor for clinical trials, reviewing safety data.
Clinical Advisory Services for Sponsors/CROs: Advising pharmaceutical companies and research organizations on best practices for conducting trials in South Africa and similar contexts.
Scientific Communications & Community Engagement: Translating complex trial concepts for communities, stakeholders, and healthcare workers to build trust and understanding.
Public Health & Programme Implementation Research
Implementation Science Research: Designing and leading studies on how to best integrate new evidence (like trial results) into real-world public health programs.
Programme Evaluation & Quality Improvement: Using research methodologies to evaluate the effectiveness of HIV/TB/PHC programs and design quality improvement initiatives.
Operational Research for Public Health: Conducting studies to solve practical problems in healthcare delivery (e.g., optimizing mobile clinic models, improving treatment adherence).
Telemedicine & Digital Health Integration
Telemedicine Clinical Service Design: Setting up and providing oversight for telemedicine platforms in clinical care and research support.
Digital Health Tool Integration in Research: Advising on and implementing the use of electronic data capture (EDC), EHR systems, and novel tools (e.g., AI for chest X-rays) in research settings.
Specialized Consulting Services
Community Engagement & Stakeholder Facilitation: Conducting community needs assessments and acting as a liaison between research sponsors, health authorities, and community leaders.
Feasibility Assessments for New Clinic/Research Sites: Evaluating the potential for establishing new primary care clinics or clinical trial sites in underserved areas.
Grant Writing & Research Proposal Development: Leveraging extensive experience to design and write competitive grant applications for clinical and public health research.
Data Safety and Monitoring Board (DSMB) Membership: Serving as an independent expert on DSMBs for clinical trials, particularly those in infectious diseases.
