Clinical Trial Site Selection in Africa

Site selection in clinical studies is a crucial step. Finding the right site for your clinical trial can be challenging. Fortunately, Infiuss can source your clinical trial site for you. We identify sites that seem to be a fit for your research; then we can arrange site selection visits as needed so you can evaluate suitability for yourself.

A site selection visit (SSV), also known as a site qualification visit (SQV) or pre-study qualification visit (PSQV) involves a representative of the sponsor organization touring a proposed clinical study site to assess its capabilities to carry out a proposed clinical trial.

A clinical trial has 4 phases of testing, approval, and monitoring.

1. Phase 1 involves testing a treatment for safety in humans, collecting and analyzing results, and submitting results to the FDA. If the FDA approves, the trial can move to Phase 2.
2. Phase 2 focuses on dosage and effectiveness of a treatment. Having determined its safety in Phase 1, tests can now be conducted to assess different treatment regimens and compare them against a control group.
3. Phase 3 broadens the testing to a wider range of individuals to ensure safety and effectiveness across more diverse populations and settings. Pending results of Phase 3 testing, the treatment is submitted for FDA approval.
4. Approval and monitoring: if the FDA approves a treatment, it enters a post-approval monitoring process. This is referred to as post-market surveillance or adverse event reporting, and the focus is on flagging adverse events that arise from the treatment’s usage.

Site selection is important in clinical trials because the suitability of a site can have a significant impact on trial outcomes. Considering the resources invested in a clinical trial, it makes sense to select a site carefully. Failure to select a high-performing site can extend timelines, exceed budget allocations and result in compromised data.

Clinical trial site monitoring involves the oversight of a clinical trial to ensure the following:

• The well-being and rights of human participants are safeguarded
• The trial is conducted according to protocol
• The trial data is complete, accurate, and verifiable
• The trial is recorded properly
• The trial is reported properly

Probe is an end-to-end decentralized clinical trial (DCT) platform that combines everything you need to carry out your research study remotely in Africa.

eProbe (probe enterprise) is our enterprise offering built to meet the most demanding requirements for larger organizations requiring control over their remote clinical trial study in Africa.

Africa has a large and growing population. By 2050, Africa will be home to over 2.5 billion people. Although previously only known for infectious diseases, Africans bear 17% of the global disease burden, which includes diseases in various therapeutic areas.

Disproportionately, only 2.5% of global clinical trials are performed in Africa. This means that the majority of clinical trials are devoid of data from a large and diverse population from the world's most genetically diverse continent.

Additionally, clinical studies can often be performed at a significantly lower cost in Africa than in North America, Europe, or other parts of the world.

We provide a flexible and adaptable service to our clients to catalyze increased access to patients and shorten cycle times. We have research professionals with global training and local expertise that perform regulatory and ethics submissions, study start-up activities, site initiations and all aspects of site monitoring and management, should our clients desire this.

We also provide real-time participant data and predictive analytics to track study enrollment, retention and completion.