At Usahihi Therapeutics, we prioritize meticulous planning and thoughtful design of every clinical trial. Our protocol development ensures that every study has clear objectives, endpoints, methodologies, and patient inclusion/exclusion criteria, setting the foundation for success. We conduct thorough site selection and feasibility assessments, identifying suitable hospitals and clinics that meet the trial’s needs. Additionally, we focus on obtaining ethics and regulatory approvals, training investigators and staff on compliance, and managing trial budgeting and contracts to ensure smooth execution of the trial.
Core Components:
- Protocol Development – Designing study protocols outlining objectives, endpoints, methodologies, inclusion/exclusion criteria, etc.
- Site Selection & Feasibility Assessment – Identifying hospitals, research centers, and clinics suitable for conducting trials.
- Ethics & Regulatory Approvals – Submitting protocols to Institutional Review Boards (IRB) and regulatory authorities for approval.
- Investigator & Site Training – Educating investigators, clinicians, and staff on trial protocols and compliance requirements.
- Trial Budgeting & Contracting – Managing financial agreements with sites, suppliers, and investigators.
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