It may sound obvious, but when looking for the right CRO for your study, you must take the time to review laboratory staff qualifications. Not only do you want to know who the technicians are that will be working on your study, but you should also ask about ancillary staff such as animal care, computer and report support personnel.
The most important person you want to meet as far as your study is concerned is the Study Director. Theirs is the first C.V. you should evaluate. The Study Director is the last person to sign off on the study, even though he/she may not be the most senior staff.
- Overall responsibility for the conduct of the study, its interpretation, analysis, documentation, and reporting of results is theirs.
- The Study Director represents the single point of control.
These are not arbitrary statements and are given as defined in the Code of Federal Regulations CFR 21, Part 58.
What are you looking for when you talk to laboratory staff and Study Director?
- Experience level
- Continuity in previous experience
- Ask questions particular to experience with this study/model
- What were some of the surprises you had with this particular model?
- Ask “hard” questions, for example, when you go to a restaurant and ask, “What’s good on the menu?” the waiter will more than likely say, “Everything!” But if you ask more probing questions like, “What is your favorite dish on the menu? Why?” you’ll get more valuable information.
- “An area of difficulty with this preparation is __________. How do you manage that?”
- “What do you believe are the strengths of this approach?
- How long have you been a Study Director for this particular model?
- “How do you monitor the responses and what do you think of the current technology for doing this? Were you involved in the validation?
- What improvements have been made in the last few years?
- When talking with technical staff
- Look to see if they have a good rapport and communication with upper management.
- How confident and knowledgeable of the preparation or the needs of the study are they?
- How long have they been part of the study team?
Staff qualifications can be the most important part of your study. Spend the time and choose wisely.