Clinical Research
CRO services through Calebyte BioSolutions, from feasibility to data management.
About CaleByte
Closing equity gaps in global research and health innovation
Bytes of Data, Breakthroughs in Health
Company overview
Who we are
CaleByte Health & Innovations LLC is a U.S.-based, Africa-focused healthcare technology and clinical research company. Founded by experts in regulatory science, oncology, and public health, CaleByte is building scalable, ethical, and data-driven healthcare and clinical research ecosystems across Africa, starting in Ethiopia.
Through its Contract Research Organization arm, Calebyte BioSolutions, the company enables global pharmaceutical, biotechnology, academic, and public health partners to conduct high-quality clinical research in African populations while strengthening local regulatory systems, workforce capacity, and digital infrastructure.
CaleByte's mission is to close equity gaps in global research and healthcare innovation by combining regulatory excellence, responsible AI-powered health tools, and long-term local capacity building.
Mission and vision
Our mission
To enable high-quality clinical research, regulatory excellence, and data-driven healthcare innovation across Africa.
Our vision
To become Africa's leading catalyst for globally integrated clinical research and health innovation.
Core values
The principles behind our work
Innovation
We apply data, technology, and responsible AI where they meaningfully improve research and care.
Integrity
We hold ourselves to transparent, evidence-based practice and honest communication with every partner.
Collaboration
We work alongside sponsors, institutions, regulators, and communities rather than around them.
Inclusion
We help ensure African populations are represented in the research that shapes global medicine.
Ethical Research
Participant safety, informed consent, and sound governance come before speed or convenience.
Sustainability
We invest in local people, systems, and infrastructure designed to outlast any single project.
Areas of expertise
Regulatory science, clinical research, and responsible AI
Our founding expertise spans regulatory science, oncology, and public health. We bring these together across four connected areas.
Regulatory Advisory
FDA, EFDA, and WHO regulatory mapping, compliance readiness, and governance.
AI Health Solutions
Validation, bias, safety, and usability testing for responsible AI health tools.
Consulting & Capacity Building
Strategy, roadmaps, and workforce development that strengthen local systems.
Geographic focus
Starting in Ethiopia, growing across East Africa
We are based in the United States and focused on Africa. Ethiopia is where we begin, with a planned expansion across East Africa.
Ethiopia
- Clinical research site readiness and operations support
- Alignment with the Ethiopian Food and Drug Authority (EFDA) and national ethics review
- Research workforce and institutional capacity building
Commitment to ethical research
Ethics is not a step in the process. It is the process.
Participant protection
Safety, dignity, and informed consent are non-negotiable in every study we support.
Independent oversight
We work within national regulatory and ethics review systems and help strengthen them.
Community engagement
Communities are partners in research, informed and involved throughout.
Responsible data and AI
Data is protected, used for its stated purpose, and AI is validated before it is trusted.
Partner with CaleByte
We work with sponsors, institutions, innovators, and public health organizations that share our commitment to ethical, high-quality research.