By Julio G.
November 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Sponsors do not choose a new Phase I program because the unit looks impressive on a tour. They choose it when three harder questions have documented answers: who on the team has actually run first-in-human (FIH) cohorts, who is medically responsible while volunteers are confined overnight and during dosing, and whether the program can prove — not promise — that it can recruit and retain healthy volunteers. Put those three answers, in that order, at the front of your capability materials and feasibility responses, and the facility becomes supporting evidence instead of your whole argument.
Facilities Are the Entry Ticket, Not the Decision
A clean unit, dedicated dosing rooms, and secure drug storage get a program into consideration. They rarely close a decision, because photographs of beds and examination rooms prove almost nothing about risk.
Sponsors, contract research organizations (CROs), and medical monitors are underwriting a different risk: the first time a new compound enters a human body, something unexpected can happen, and the team on site that day has to recognize it, act, document it, and communicate it clearly. That risk is carried by people, coverage, and recruitment systems.
One: Team First-in-Human Experience
Name the principal investigator (PI) and describe the PI's early-phase work in concrete terms: early-phase cohorts supervised, dose-escalation designs run, experience with sentinel dosing (dosing one or two volunteers first and observing them before the rest of the cohort is dosed), and familiarity with predefined stopping rules. Do the same, in shorter form, for the sub-investigators, lead coordinator, pharmacist, and safety assessment staff.
Evidence that counts includes:
- A one-page experience matrix listing each key team member, role, early-phase responsibilities, and training dates
- Redacted training records and delegation logs from prior early-phase studies
- A list of standard operating procedure (SOP) titles covering dosing, safety reporting, emergency response, and data capture, with revision dates
- Documented experience with adverse events (AEs) and serious adverse events (SAEs), described by process — how events were assessed, escalated, and reported — rather than by naming sponsors or compounds you are not free to disclose
What reads as marketing is the phrase “experienced early-phase team” with no names, no cohort history, and no dates. Sponsors hear that phrase from everyone. They trust a matrix they can verify in a qualification visit and cross-check against curricula vitae (CVs).
Two: Medical Coverage for Confinement
Confinement changes the medical question from “who is the PI?” to “who is responsible at 2:00 in the morning on the second night, and what happens next if a volunteer deteriorates?”
Your materials should include a sample coverage roster for a typical confinement period, not just a statement that coverage exists. Show who is physically present, who is on call and within what response time, and who decides on dosing pauses, additional monitoring, and hospital transfer.
Cover these points explicitly:
- Dosing windows: Which clinician is present for dosing and the highest-risk observation period after it, and what safety assessments — vital signs, electrocardiogram (ECG) monitoring, laboratory sampling — are performed and reviewed in that window
- Overnight coverage: Who is in the unit overnight, what qualifications that person holds, and which decisions that person can make alone
- Escalation path: A written, step-by-step chain from bedside staff to the PI or covering physician to emergency services and hospital transfer, including who accompanies the volunteer
- Equipment and rehearsal: Emergency equipment checks, crash cart location, and evidence of scheduled, documented mock emergency drills
- Communication: How and how quickly the sponsor and medical monitor are notified of an SAE, and who makes that call
What reads as marketing is “24-hour medical coverage” as a single line. Sponsors will probe it in feasibility calls, and a vague answer there undoes good answers everywhere else. A one-page coverage and escalation summary, signed by your PI, is one of the highest-value pages a new program can produce.
Three: Documented Healthy-Volunteer Recruitment
Patients and healthy volunteers are different recruitment problems. A site that recruits patients well through physician referrals may still fail a Phase I cohort if it has no healthy-volunteer community and no plan for no-shows.
Sponsors want a screening funnel with real numbers from your own records. For a defined recent period, report how many volunteers are in your database and actively contactable, how many were pre-screened, attended screening, passed screening, were dosed, and completed. Include your most common screen-failure reasons in general terms, because that tells a sponsor whether your population fits a protocol's eligibility criteria.
Then explain the operational details that protect a cohort date:
- Throughput: How many screening visits the unit can run per day without crowding out dosing or follow-up visits
- No-show handling: Reminder cadence, confirmation steps, and the confirmed backup pool held for each cohort so one absence does not delay dosing
- Retention: How you keep volunteers through confinement and follow-up — scheduling clarity, payment timing explained in plain language, and a single point of contact — and what your completion rate shows
What reads as marketing is “large volunteer database” and “proven recruitment.” Database size without contactability and screening data is a vanity number. A modest database with a documented funnel and a strong completion rate beats a huge list nobody has called in two years.
The Order Sponsors Actually Evaluate This
In practice, evaluation follows the order of risk. First, can this team run an FIH cohort safely? Second, is a confined volunteer medically covered at every hour, with a tested escalation path? Third, will the cohort be filled, on schedule, with volunteers who stay to completion? Only then do sponsors weigh facilities in detail, timelines, and cost.
That order should shape your feasibility responses. Answer the exact question asked, attach the evidence instead of describing it, and name the owner of each answer. If a question asks about overnight coverage, “the PI is responsible for all medical decisions” is not an answer. The roster, the response times, and the escalation chain are the answer.
It should also shape how you present your gaps. If one area is still developing, say so plainly and state what is in place and what is being built, with dates. Sponsors place programs they caught being honest far more readily than programs they caught exaggerating. One overstated claim — an aspirational coverage arrangement, a database figure that collapses under questioning — casts doubt on every other page you submitted.
A Short Checklist for Your Capability Materials
Before your next sponsor call or feasibility submission, confirm you can hand over each of these:
- One-page team experience matrix for the PI, sub-investigators, lead coordinator, and pharmacist
- SOP title list with revision dates for dosing, safety reporting, and emergencies
- Sample confinement coverage roster showing present and on-call staff by time block
- One-page escalation and hospital transfer summary signed by the PI
- Record of the most recent mock emergency drill, with date and participants
- Healthy-volunteer screening funnel with defined dates and real counts at each stage
- Written no-show and backup-pool plan for cohort dosing days
- Named contact for each of the three areas, so a sponsor question reaches the right person the first time
If an item on that list does not exist yet, building it is your development plan for the next quarter. Each document is inexpensive to produce, and together they answer the questions that decide awards.
Put the Proof Where Sponsors Look First
I lead bioaccess, a first-in-human CRO that runs early-phase trials anywhere from Canada down to Argentina, and Amavita Research Services, a Miami cardiovascular trial site with 18,000-plus active cardiology patients and zero United States Food and Drug Administration (FDA) Form 483 findings. Working on both sides — selecting sites and being selected — I see the same pattern: new programs lose awards they could have won because they led with their building and buried their proof.
Build the proof first. Lead with the team that has run cohorts, the coverage that protects a confined volunteer at every hour, and the recruitment record that fills a cohort on time. Then show the facility.
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.