This is an awkward article for a consultant to write, so let me be direct about the conflict: I sell clinical operations consulting. What follows is how I would evaluate someone in my position, including the questions I would find hardest to answer well.
Ask what they have run, not what they have advised on
There is a meaningful difference between having sat in governance meetings and having owned the outcome of one. Both have value. They are not the same, and the language used to describe them is nearly identical.
Ask for a specific engagement: what was the situation, what did you actually do, what happened, and what would you do differently. Someone who has run the work answers operationally and mentions something that went badly. Someone who has not answers in outcomes and benefits.
Ask which side of the relationship they have worked
Sponsor-side and CRO-side experience produce different instincts. A consultant who has only worked sponsor-side often underestimates what a CRO is absorbing. One who has only worked CRO-side can be too forgiving of vendor behavior a sponsor should not accept.
Experience on both sides is not a requirement, but it is worth knowing which lens you are buying, and asking directly what they think the other side would say about the same situation.
Ask who will do the work
In larger firms the person selling is rarely the person delivering. That is not inherently wrong, but it should be disclosed and it should be in the contract. Ask for the delivery team by name and ask what else they are committed to.
In a boutique or solo practice the answer should be simple: the person you are speaking to. If it is not, ask why.
Ask what they would decline
This is the most revealing question I know of, and the most uncomfortable to receive.
A consultant who takes every engagement is selling capacity. One with judgment will have a clear answer — work outside their therapeutic experience, situations where the real problem is a decision the client has already made, engagements where the scope suggests the sponsor wants validation rather than assessment.
Listen for whether the answer is specific. "I only take work where I can add value" is not an answer.
Ask what they will need from you
Every serious engagement consumes client time — interviews, document access, decisions, introductions. A consultant who says they will need almost nothing is either not planning to look closely or is planning to deliver something generic.
Ask for the estimate in hours, by role, by week. It is a fair question and the answer tells you how the work will actually run.
Ask what would make them tell you not to proceed
The answer should exist. If the engagement is a CRO selection and the honest recommendation might be that you are not ready to run one, a good consultant will say so before taking the money, not three weeks in.
What to weigh less than you might expect
Company size, for most engagements under six months. Volume of published content — visibility is not competence, and this article is itself an example of content marketing. Certifications, which indicate training rather than judgment. And the polish of the proposal, which correlates with business development investment rather than delivery quality.
Scope the engagement before you compare prices
Two proposals at different prices are often quoting different work, and the cheaper one is frequently cheaper because it is smaller. Before comparing, write down what you need to exist at the end — a selected CRO and an executed contract, a governance charter and a working cadence, a remediation plan with owners — and ask each consultant to price against that.
It also clarifies shape. Defined-scope work should be quoted against a deliverable. Ongoing oversight or leadership is a retainer. Open-ended hourly arrangements suit the consultant's risk profile rather than yours, and are worth questioning unless the scope is genuinely unknowable.
Comparing two credible options
When both look capable, compare specificity. Ask each to describe the first three weeks: what they would read, who they would speak to, what they would produce by the end of it. Someone who has done the work will answer in detail immediately, because they have a method. Someone who has not will describe a discovery phase.
Then check one reference each and ask the same question of both: what did they get wrong, and how did they handle it. The comparison is usually decided there.
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