Clinical Trial Services
End-to-end operational support from feasibility and site identification through study start-up, monitoring, and coordination.
- Trial feasibility
- Site identification
- Study start-up
- Clinical operations
Calebyte BioSolutions
Advancing Clinical Research Across Africa
Enabling globally aligned clinical research through local expertise, regulatory excellence, and data-driven operations.
The Contract Research Organization of CaleByte Health & Innovations
CRO overview
Globally aligned research, locally grounded
Calebyte BioSolutions is the Contract Research Organization (CRO) arm of CaleByte Health & Innovations. We help pharmaceutical, biotechnology, academic, and public health sponsors plan and run high-quality clinical research in African populations, starting in Ethiopia.
African populations remain under-represented in the clinical research that shapes global medicine. We work to change that responsibly by pairing international standards with local regulatory knowledge, site partnerships, and data operations designed for the settings where studies take place.
Who we serve
Partners across the research ecosystem
Pharmaceutical sponsors
Expanding development programs to include diverse African populations.
Biotechnology companies
Seeking practical, well-governed pathways to run studies in new regions.
Academic institutions
Running investigator-initiated and collaborative research programs.
Public health organizations
Generating evidence for programs, interventions, and health policy.
CRO services
Comprehensive clinical research support
Choose the services you need, or work with us across the full study lifecycle.
Regulatory & Ethics Support
Regulatory strategy, submissions, and ethics committee coordination that keep your study compliant and participants protected.
- Regulatory strategy
- Regulatory submissions
- Ethics committee coordination
- IRB support
Site Readiness
Prepare research sites with the infrastructure, people, workflows, and quality systems needed to run studies to international standards.
- Site feasibility
- Infrastructure readiness
- Staff training
- Operational workflows
Data Management & Biostatistics
Clinical data management, quality control, biostatistics, and analytics that turn study data into reliable evidence.
- Clinical data management
- Data quality
- Biostatistics
- Research analytics
Pharmacovigilance
Safety reporting, adverse event documentation, and pharmacovigilance processes that protect participants and meet reporting obligations.
- Safety reporting support
- Adverse event documentation
- Safety data coordination
- Pharmacovigilance processes
Research Technology
Digital workflows, data infrastructure, interoperability, and responsible AI that modernize how clinical research is run.
- Digital research workflows
- Clinical research technology
- Research analytics
- Data infrastructure
Study lifecycle
Support at every stage of your study
Why Calebyte BioSolutions
What sponsors can rely on
Africa-first operations
Study plans shaped by local health systems, languages, and infrastructure from day one.
Regulatory science foundation
Grounded in FDA, EFDA, WHO, and ICH Good Clinical Practice expectations.
Ethics at the centre
Participant protection, informed consent, and community engagement built into every study.
Data you can trust
Data management, biostatistics, and technology designed for quality and traceability.
Planning a study in Africa?
Share your protocol stage, therapeutic area, and timelines. We will help you understand feasibility and next steps.