Bid defense questions: what sponsors ask, and how to answer
Sponsors use the bid defense to test whether your proposal holds up. These are the 29 questions they ask most, grouped by theme, with what each one is really testing and what a strong answer includes.
- Most questions fall into seven groups. Enrollment and sites draw the most, and the hardest.
- Behind almost every question is one worry: will this trial enroll on time and on budget?
- A strong answer is short, has a number in it, and points to something the sponsor can check.
- Give every question group an owner before the meeting, so the right person answers.
- Ask the sponsor good questions too. It shows you have read the protocol.
A bid defense is where a shortlisted CRO presents and defends its proposal to the sponsor. The presentation matters, but the decision is usually made in the questions. Use this list to assign an owner to each group and rehearse the answers out loud. You will not get every question, but you will get most of the themes. For the full preparation timeline, see how to prepare for a bid defense meeting.
Group 1Enrollment and sites Most questions
Expect the most questions here, and the hardest. Sponsors have reason to push: Tufts CSDD found that about 37% of trial sites under-enroll and about 11% never enroll a single patient (the cost of guessing).
How do you know these sites will enroll this study?
Whether your site list rests on evidence, or on reputation and relationships.
The qualifying patient count at each site, the investigator who will deliver them, and the reason each site is on the list.
How many patients who meet our criteria does each site actually see?
Whether you looked past the diagnosis to the inclusion and exclusion criteria.
A count for each site against this protocol’s criteria, not a disease total or an average.
Why these sites, and not the usual academic centers?
Whether you can defend a list that differs from the one they expected.
The evidence for each site you chose, and the specific reason each well-known center was left off.
What enrollment rate are you assuming per site, and where does it come from?
Whether your timeline rests on a benchmark or on this study’s real patient pool.
The rate, its source, and how it changes for the slower sites on the list.
What happens if a site has not enrolled after 90 days?
Whether you have a plan before there is a problem.
A named trigger, backup sites already identified, and who makes the call.
How will you reach patients who are not already known to the site?
Whether your plan depends only on the site’s existing patients.
Where those patients are treated, the referral routes into each site, and any recruitment support you will fund.
Group 2Investigators
Sponsors want to know the people, not just the institutions.
Which investigators have run trials like this one, and how did they enroll?
Track record on similar studies, not a CV.
Named investigators and their record on trials like this one: the indication, the phase and how enrollment went.
How many competing trials are these investigators running right now?
Whether your sites will have the time and the patients for this study.
The current competing studies at each site, and how you allowed for them in the plan.
Has each investigator confirmed interest and capacity?
Whether the list is real or still a wish list.
The confirmation status of each site, with dates.
How long do these sites usually take from contract to activation?
Whether your start-up timeline is realistic.
Past activation times at these sites, not a company-wide average.
Group 3The team
The sponsor is choosing who they will work with for years.
Who will run this study day to day, and how much of their time is committed?
Whether the people in the room are the people on the study.
Named leads, the share of their time committed, and what else they are working on.
What happens if the project manager leaves?
Continuity, and whether one person is a single point of failure.
A named deputy who knows the study, and how handover works.
Have the people in this room worked together before?
Whether this is a team or a group assembled for the pitch.
Studies this team has delivered together, and how they split the work.
How often will we hear from you, and in what form?
Whether the sponsor will see problems early.
A reporting rhythm, what each report contains, and how issues are escalated.
Group 4Timeline
Every timeline question is really an enrollment question in disguise.
How long from contract to first patient in, and what is that based on?
Whether the start-up plan has any working behind it.
Each step with its duration, and the evidence for the slowest one.
Where is the timeline most likely to slip?
Whether you know your own weak points.
The one or two risks you would watch first, and the early signal for each.
What does your enrollment curve look like, month by month?
Whether the plan is built site by site or drawn as a straight line.
A curve built from site activation dates and site-level rates, with a slower case beside it.
What would it take to bring last patient in forward?
Flexibility, and what it would cost.
The levers you would pull, such as more sites or earlier activation, and the cost of each.
Group 5Budget
Budget questions are usually about the assumptions, not the total.
Why is your budget different from the others on this line?
Whether the difference comes from scope or from assumptions.
The specific assumptions that drive the gap: number of sites, enrollment rate and screen failure.
What site and patient assumptions sit behind the numbers?
Whether the budget and the enrollment plan agree with each other.
The same site count and rates you used in the enrollment plan, stated plainly.
What happens to cost if enrollment runs slower than planned?
Exposure to delay.
The cost of each extra month, and the point at which you would add sites.
Which costs are fixed and which move with enrollment?
Whether the sponsor can predict their spend.
A short split of fixed and variable costs.
Group 6Protocol and risk
This is where you show you have read the protocol closely. It overlaps with feasibility (see bid defense vs feasibility).
What is the biggest risk in this protocol?
Judgment, and whether you will tell them something they do not want to hear.
One clear risk, why it matters for enrollment or data, and what you would do about it.
Which eligibility criteria will be hardest to meet?
Whether you understand who actually qualifies.
The criteria that remove the most patients, and whether any could change without hurting the science.
If you could change one thing in the protocol, what would it be?
Whether you think like a partner or an order taker.
A specific, respectful suggestion with the reason behind it.
What is your plan if screen failure runs higher than expected?
Contingency planning.
The screen failure rate you assumed, the point at which you would act, and what you would do.
Group 7Track record
Sponsors check whether your past matches your promises.
Have you run trials in this indication before, and how did they enroll?
Relevant experience, not total experience.
Similar studies, how enrollment went against plan, and what you learned.
Tell us about a study that went wrong. What did you change?
Honesty, and whether you learn.
A real example, what caused it, and the specific change you made since.
Can we speak to a sponsor you have worked with?
Whether others would choose you again.
A reference ready to take the call, on a similar study.
Worked exampleWeak answer, strong answer
The same question, answered two ways. The figures are illustrative.
“How do you know these sites will enroll this study?”
“We have strong relationships in this indication and have worked with most of these sites before. We are confident in the enrollment plan.”
“Every site on the list sees patients who meet your criteria. Site 4, for example, has 46 qualifying patients, and its investigator has enrolled three similar trials on plan. Two well-known centers were left off because each sees fewer than ten.”
The strong answer takes about the same time to say. The difference is that every part of it can be checked.
PreparationHow to prepare your answers
- An owner. Every group above has one person who answers it, and everyone knows who.
- One number. Each answer contains at least one figure the sponsor can write down.
- The evidence. Each number has a source you can show, ideally in an appendix the sponsor keeps.
- Sixty seconds. If an answer runs longer than a minute, cut it. The sponsor will ask a follow-up if they want more.
Your turnQuestions to ask the sponsor
Most bid defenses leave time for the CRO to ask questions. Use it. Good questions show you have read the protocol and care how the study goes.
- What concerns you most about this study?
- What did you learn from the last trial in this program?
- How will you make the decision, and when?
- Is there anything in our proposal you would like us to clarify in writing?
For sponsorsIf you are the sponsor
If you are running the bid defense, a few habits make the answers easier to compare across CROs:
- Ask every CRO the same enrollment questions, so the answers line up side by side.
- Ask for counts at each site against your own criteria, not totals for the disease.
- Ask where each enrollment rate comes from.
- Ask which well-known centers were left off, and why.
Bid defense questions, answered
What questions are asked at a bid defense?
Most fall into seven groups: enrollment and sites, investigators, the team, timeline, budget, protocol risk and track record. Enrollment draws the most questions, because it is the hardest part of a bid to prove.
What is the most important question at a bid defense?
Usually some version of “How do you know these sites will enroll this study?” It tests whether the site list rests on evidence, and the answer shapes how the sponsor reads the timeline and the budget.
How should a CRO answer enrollment questions at a bid defense?
With a number the sponsor can check: the count of patients who meet the protocol’s criteria at each site, the investigator who will deliver them, and why each site is on the list. Averages and questionnaire responses carry less weight.
What questions should a CRO ask the sponsor at a bid defense?
Ask what concerns them most about the study, what they learned from earlier trials in the program, how and when they will decide, and whether anything in the proposal needs clarifying in writing.
Who answers the questions at a bid defense?
The person who will own that area on the study: the project manager for the plan and timeline, the clinical lead for the protocol, and the feasibility or site lead for sites and enrollment. Agree the owners before the meeting.