Clinical Research
CRO services through Calebyte BioSolutions, from feasibility to data management.
Healthcare technology & clinical research
Accelerating Health Innovation Across Africa & Beyond
Precision medicine, AI health tools, regulatory solutions, and clinical research support designed for real-world impact.
Who we are
Connecting Scientific Expertise with Healthcare Innovation
CaleByte Health & Innovations is a U.S.-based, Africa-focused healthcare technology and clinical research company. Founded by experts in regulatory science, oncology, and public health, we are building scalable, ethical, and data-driven research and healthcare ecosystems, starting in Ethiopia.
We help global sponsors, health innovators, and institutions conduct high-quality research in African populations, adopt AI responsibly, and navigate complex regulatory requirements, while investing in the local people and systems that make lasting progress possible.
Our expertise
Integrated support from research design to real-world impact
Four connected areas of expertise, delivered by one team with a shared commitment to ethical, high-quality work.
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.
Calebyte BioSolutions
Advancing Clinical Research Across Africa
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.
Explore Calebyte BioSolutions- Clinical Trial ServicesTrial feasibility · Site identification · Study start-up
- Regulatory & Ethics SupportRegulatory strategy · Regulatory submissions · Ethics committee coordination
- Site ReadinessSite feasibility · Infrastructure readiness · Staff training
- Data Management & BiostatisticsClinical data management · Data quality · Biostatistics
- PharmacovigilanceSafety reporting support · Adverse event documentation · Safety data coordination
- Research TechnologyDigital research workflows · Clinical research technology · Research analytics
Why CaleByte
Built for research and innovation that lasts
Africa-first expertise
Programs designed around African health systems, populations, and priorities from the start.
Global research alignment
Work aligned with international standards, including ICH Good Clinical Practice.
Regulatory science foundation
Founded by experts in regulatory science, with FDA, EFDA, and WHO expectations built in.
Ethical research
Participant protection, consent, and community engagement at the centre of every engagement.
Data-driven innovation
Responsible use of data, analytics, and AI to improve research and care.
Sustainable capacity building
Long-term investment in local people, institutions, and infrastructure.
Geographic focus
Rooted in Africa. Connected to Global Innovation.
We connect U.S. and global research partners with African institutions, starting in Ethiopia and expanding 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
Insights
Perspectives on research and health innovation
The articles below are sample content shown for demonstration while our publication program is prepared.
Clinical ResearchSample contentWhy African Representation in Clinical Trials Matters
Medicines are used worldwide, but the evidence behind them often is not. We look at why diverse participation strengthens global research and what responsible inclusion requires.
6 min read
Regulatory ScienceSample contentNavigating FDA, EFDA, and WHO Expectations Together
Regulatory requirements overlap more than many teams expect. A practical look at mapping pathways across authorities without duplicating effort.
7 min read
AI in HealthSample contentTesting Health Chatbots for Safety and Bias
Conversational AI can extend access to health information, but only if it behaves safely. An overview of what a responsible test plan should include.
8 min read
Let's Advance Healthcare Innovation Together
Whether you are planning a clinical study, validating an AI health tool, or strengthening research capacity, we would welcome a conversation.