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...