Bid defense vs feasibility: what each one is, and how they connect
Feasibility and the bid defense are two stages of the same CRO selection process. Feasibility asks whether and where a trial can enroll. The bid defense is where the CRO proves that answer to the sponsor.
- Feasibility answers “can this protocol enroll, and where?” It produces the site list and the enrollment plan.
- The bid defense answers “why should we trust you to deliver it?” It is where the sponsor decides.
- Feasibility comes first. The bid defense is where it gets tested.
- Most of the hardest bid defense questions are feasibility questions.
- Feasibility built on counts the sponsor can check is far easier to defend than feasibility built on estimates.
The short answerTwo stages, one question
“Can this protocol enroll, and where?”
The assessment of whether a study can realistically enroll, at which sites and how fast. It produces the site list, the enrollment assumptions and the timeline in the proposal. More on clinical trial feasibility.
“Why should we trust you to deliver it?”
The meeting where a shortlisted CRO presents and defends its proposal to the sponsor: the team, the timeline, the budget and the sites. It usually decides the award. More on the bid defense.
The processWhere each one sits
Feasibility shapes the written proposal. The bid defense comes after the sponsor has cut the field to a shortlist, and the gap varies: a CRO might be called to defend its bid within days, or a couple of months later.
- RFP issued
- Feasibility
- Written proposal
- Shortlist
- Bid defense
- Award
- Site activation
- Enrollment
Feasibility does not stop at the award. It is usually refined again before sites are activated, when the study team confirms each site and its investigator.
Side by sideHow they differ
| Feasibility | Bid defense | |
|---|---|---|
| The question it answers | Can this protocol enroll, and where? | Why should we trust you to deliver it? |
| When it happens | Before and during the proposal, and again before sites are activated | After the shortlist, before the contract is awarded |
| Who leads it at the CRO | The feasibility or site selection team | The proposed project manager, with clinical, feasibility and business development leads |
| Who it is for | The CRO’s own planning, and the written proposal | The sponsor’s selection team |
| What it produces | A site list, enrollment assumptions and a timeline | A decision: award the work or not |
| What it draws on | Site questionnaires, past performance and patient data | The proposal, the team and the evidence behind the plan |
| How it goes wrong | Optimistic assumptions that nobody tests | A plan the team cannot defend under questioning |
| How it is judged | Whether the sites go on to enroll | Whether the sponsor awards the work |
The linkThe bid defense tests the feasibility
Look at the questions sponsors ask in the room. How many qualifying patients does each site see? Where does the enrollment rate come from? Why these sites and not the usual academic centers? Every one of them is a feasibility question. (We collected them in 29 bid defense questions sponsors ask.)
So the quality of the feasibility work shows up twice. First in the bid defense, where the sponsor decides whether to trust it. Then in the trial, where the sites either enroll or they do not.
The second test is the expensive one. Tufts CSDD found that about 37% of trial sites under-enroll, about 11% never enroll a single patient, and 53% of studies run past their enrollment timeline. Sponsors know these numbers, which is why they push hardest on the enrollment plan. (The cost of guessing.)
The partsThe three kinds of feasibility
- Protocol feasibility. Can the study enroll as written? Which eligibility criteria remove the most patients, and could any change without hurting the science?
- Country feasibility. Which countries have enough qualifying patients, the right standard of care and workable start-up timelines?
- Site feasibility. Which sites see the patients, which investigators have run trials like this one, and how many competing studies are they already running?
Sponsors often run their own protocol feasibility before they issue an RFP. CROs usually lead on country and site feasibility. At the bid defense, all three come up.
In practiceBuild feasibility you can defend
If the feasibility work is going to be tested in front of the sponsor, build it that way from the start:
- Count the patients who meet this protocol’s criteria at each site, not the disease total
- Name the investigator at each site, and their record on trials like this one
- Write down the reason each site is on the list
- Note which well-known centers you left off, and why
- Keep the source of every enrollment rate you assume
- Put the detail in an appendix the sponsor can take away
Feasibility built this way turns the hardest part of the bid defense into the strongest. For the meeting itself, see how to prepare for a bid defense meeting.
Common mix-upsWhat people get wrong
- Treating feasibility as a form to fill in, rather than the evidence the bid will be judged on.
- Building the site list from reputation, then trying to justify it at the bid defense.
- Sending a pitch team to the bid defense, without the feasibility lead who built the plan.
- Doing feasibility once, and not revisiting it before sites are activated.
Bid defense and feasibility, answered
What is the difference between feasibility and a bid defense?
Feasibility asks whether and where a trial can enroll, and produces the site list and enrollment plan. A bid defense is the meeting where a shortlisted CRO defends that plan, its team and its budget to the sponsor to win the contract.
Which comes first, feasibility or the bid defense?
Feasibility comes first. The CRO assesses the protocol, countries and sites while it writes the proposal. The bid defense comes later, after the sponsor has shortlisted a few CROs, and the feasibility work is what gets tested there.
Who is responsible for feasibility at a CRO?
Usually a feasibility or site selection team, working with clinical and medical leads. At the bid defense, the feasibility or site lead typically answers the questions about sites and enrollment.
Do sponsors run their own feasibility?
Often, yes. Many sponsors assess protocol feasibility before they issue an RFP, then compare what each CRO proposes against their own view. That is one reason enrollment questions at a bid defense can be so specific.
How does feasibility affect the bid defense?
Directly. Most of the hardest bid defense questions are feasibility questions: how many qualifying patients each site sees, where the enrollment rate comes from, and why each site is on the list. Strong feasibility makes those answers easy to give and easy to check.