Regulatory Readiness Is Not the Same as Regulatory Delay

Regulatory Readiness Is Not the Same as Regulatory Delay

When a clinical trial in Africa stalls, the explanation is often immediate: “regulatory delay.” It is a convenient phrase. It is also too often an incomplete one. “Regulatory delay” can mean many different things. It can mean a regulator took longer than expected. It...
What Sponsors Actually Need from African Trial Networks

What Sponsors Actually Need from African Trial Networks

By now, the argument for Africa’s inclusion in global clinical research is well established. The scientific rationale is clear. The public health need is clear. The access imperative is clear. But sponsors do not place complex Phase II and III trials solely on the...
Why Feasibility Assessments Fail in African Clinical Research

Why Feasibility Assessments Fail in African Clinical Research

What if many clinical trial delays attributed to African sites begin much earlier — in weak feasibility design?  When a study misses its first-patient-in date or enrolment lags, the explanation is often reduced to a familiar shorthand: “Africa is difficult.” But that...