Every feasibility questionnaire a site answers can be accurate, and the portfolio can still fail.
November 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Feasibility is true study by study — and false for the portfolio
Feasibility usually asks a narrow question: can this site do this study? Does it have the right patients, the right principal investigator (PI), the right equipment, and experience with similar protocols? Answered one study at a time, the answer is often yes — honestly yes.
The problem is that no study arrives into an empty site. A new award lands on top of studies already screening, enrolling, and following patients. It competes for coordinator time during start-up, for the PI during protocol training, for pharmacy during dispensing windows, and for imaging slots and beds on visit days. None of that competition appears on a single-study feasibility form.
So each answer is locally true and collectively false. The site could do any one of the studies. It cannot do all of them, at the promised pace, with the team it actually has.
I see this from both sides of the table. I am chief executive officer (CEO) of bioaccess, a first-in-human (FIH) contract research organization (CRO) that runs early-stage trials anywhere from Canada down to Argentina, and CEO of Amavita Research Services, a Miami cardiovascular trial site with 18,000+ active cardiology patients and zero Food and Drug Administration (FDA) Form 483 findings. As a CRO, I need feasibility answers I can trust. As a site leader, I know why a confident answer in January can become a strained forecast by June. The difference is rarely effort or honesty. It is visibility.
What feasibility drift actually looks like
Feasibility drift never announces itself as a crisis. It accumulates quietly, one decision at a time.
A coordinator takes on one more study because the start-up work looks light. Then two studies enter active screening in the same month. Screening visits take longer than planned, source documents pile up, and follow-up visits for an older study compete with first visits for a newer one. The coordinator is not failing. The arithmetic changed underneath her.
The same pattern repeats with shared resources. The PI can support each protocol in isolation, but medical review, eligibility sign-off, and safety assessment all arrive on the same days. Pharmacy can handle each study alone, but not three dispensing windows in one morning. Imaging can accommodate every protocol on paper, until the schedules align and there are not enough slots for patients already consented.
The symptoms come later: enrollment that starts strong and turns volatile, timelines that slip a week at a time, overtime that becomes permanent, and margins that erode as the site pays premium hours to keep ordinary promises. Sponsors experience this as inconsistency. Sites experience it as exhaustion. Both are looking at the same root cause — commitments made without a portfolio view.
The one view: portfolio capacity, not study capacity
The fix is not a more detailed feasibility questionnaire. It is a second question, asked before any new study is accepted: what does this commitment do to everything else we have already promised?
Answering it takes one portfolio capacity view — a single page, or a single screen, that shows the whole site at once. It does not need specialized software. A spreadsheet maintained honestly will outperform an expensive system nobody updates. What matters is what it contains.
Coordinator hours by study and phase. List every study, its current phase — start-up, screening, enrollment, follow-up, or close-out — and the coordinator hours it actually consumes each week, not the hours budgeted at award. Phases matter because a study in follow-up may need a fraction of the time it needed during screening. Totals by person matter most: if one coordinator's assigned hours already meet her available hours, the portfolio is over-committed before any new study is discussed.
Shared resources. Add the resources no single study owns: PI hours for review and sign-off, pharmacy capacity, imaging slots, procedure rooms, and beds. Record both the capacity available each week and the capacity already claimed. Shared resources are where portfolios break first, because each feasibility answer quietly assumes full access to them.
Forward load. Extend the view eight to twelve weeks ahead. A portfolio that looks manageable today can be impossible next month, when two awarded studies change phase and screen at once. The forward view makes that collision visible while there is still time to negotiate it.
A clear total. End with one honest line: capacity available, capacity committed, and the remainder. That remainder — positive or negative — is the real answer to the next feasibility question.
A weekly review ritual that takes thirty minutes
A capacity view only works if someone looks at it before commitments are made, not after problems appear. The review has to be a ritual, not a report.
Once a week, site leadership — the site director, the lead coordinator, and whoever manages feasibility — spends thirty minutes with the view. The agenda never changes.
First, update reality. Each study owner confirms the phase and the actual hours consumed last week. If a study is taking more time than planned, the view changes that day, not at the end of the quarter.
Second, look forward. Walk the next eight to twelve weeks and name the collisions out loud: two screening pushes in the same week, a PI bottleneck, a pharmacy or imaging pinch point. Naming a collision early creates options — stagger a start date, sequence screening, or add temporary support. Discovering it late creates only apologies.
Third, decide on new business against the remainder. Every pending feasibility answer and likely award is tested against the numbers just reviewed. If the remainder cannot absorb the study, the answer is not a hopeful yes.
Fourth, record the decision and the reason. Over time, that record shows which phases were underestimated and which resources run short — and how much confidence the next answer deserves.
The honest "not yet" conversation with a sponsor
The hardest part of a capacity view is not building it. It is what it requires a site to say.
Sites fear that any hesitation loses the study. In my experience, the opposite is true. Sponsors and CROs plan around the answers they receive, and a yes that quietly borrows from other studies damages trust far more than an early explanation of timing.
An honest answer has three parts. Name the constraint plainly: coordinator hours are fully committed through a specific period, or a shared resource is already claimed by studies in active screening. Give the specific alternative: start on a stated date, begin with a smaller enrollment target, or stagger screening so the commitment is real. Then connect it to the sponsor's own interest: the point of the delay or smaller start is that the enrollment promised is the enrollment the sponsor will actually get.
"Not yet" is not "no." Neither is a reduced target a lack of ambition. Both are what a credible commitment sounds like from a site that can see its whole portfolio. A sponsor may still choose another site for an urgent timeline — a legitimate outcome, and better than an award that produces volatile enrollment, burned-out staff, and a relationship that does not survive the study.
What changes when a site can see itself whole
A portfolio capacity view changes feasibility from a sales answer into an operational commitment. Enrollment steadies because new work is only accepted when the people and resources to deliver it demonstrably exist. Margins improve because the site stops paying overtime to cover gaps that were visible weeks earlier. Staff stay longer because their workload was decided honestly instead of discovered painfully.
Most importantly, the site's word gets stronger. Every promise is made against the same visible reality, so promises stop competing in the dark.
Before accepting the next study, build the one view: every study, every coordinator hour, and every shared resource on a single page, reviewed weekly. Answer feasibility from the portfolio, not from hope. That is how drift stops.
*Julio G. Martinez-Clark is CEO of bioaccess and of Amavita Research Services in Miami.*
Julio G. Martinez-Clark is chief executive officer (CEO) of bioaccess\u00AE, a first-in-human contract research organization running early-phase trials anywhere from Canada down to Argentina, and of Amavita Research Services, a Miami cardiovascular research site he has operated for seven years with zero United States Food and Drug Administration (FDA) Form 483 inspection findings. He founded Global Trial Accelerators\u2122, a podcast for medtech and biotech founders navigating first-in-human studies.