Trial Readiness Is Not a Status. It Is an Execution Condition.

Trial Readiness Is Not a Status. It Is an Execution Condition.

In clinical research, few words carry more operational risk than “ready.” A site may be described as ready when a Research Ethics Committee or Institutional Review Board has approved the protocol. A network may be described as ready when a master agreement is in...
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...