Rinda Ubuzima has an experimented Research Team composed by Medical Doctors, Research Nurses, Social Workers and other Health care Professionals that are the helm of all clinical trials exercises.
A clinical trial is a research study conducted in human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that help people.
It is well known that clinical trials are conducted in phases. Each phase is designed to answer certain questions, while taking necessary steps to safeguard the people taking part. Every new treatment is usually tested in three phases of clinical trials before regulatory agencies consider it safe and effective. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.
At Rinda ubuzima we conduct each trial according to the protocol and all Trials are also conducted according to Good Clinical Practice (GCP) guidelines that regulators require in order to protect patient safety. Rinda Ubuzima has the capacity to conduct each phase among the three phases of the clinical trial.
Rinda Ubuzima conducts all administrative procedures prior to the start of the clinical trial exercise.
Based on Rwanda context, we ensure that:
– All regulatory bodies’ approvals are obtained (i.e.: Rwanda National Ethics Committee (RNEC), Rwanda Food and Drugs Authority (Rwanda FDA), National Health Research Committee (NHRC), and Rwanda Biomedical Centre (RBC) etc.).
– Both the study team and partners are well trained to carry out the study. An emphasis is put on patient information and informed consent, Data collection and management, measure outcomes, as well as safety monitoring.
– Analysis are conducted using appropriate statistical methods
– Compare to null hypothesis is examined (proven or disproven, statistically significant difference or not)
– Errors consideration are taken into account (Source of bias, patients lost to follow-up, adverse effects, surprising benefits)
– All materials are submitted to the sponsor for publication