The fundamental of any successful clinical operations department is its structure, people, processes and systems. The execution of clinical trials can be challenging if the organization is not at its optimal functioning.
Standard Operating Procedures (SOPs) ensure consistency, compliance and accountability at all levels of clinical trials. Companies without SOPs runs a high risk of GCP non-compliance and poor productivity.
Outsourcing is like a partnership – they should be formed for mutual benefit. Each party's goals and expectations should be clearly understood and be transparent from the outset of the collaboration.
"What GCP training have your had?" is often the first question from an inspector to a staff member. Though it's a basic question, it can floor anyone who is unprepared.