Sponsors shortlist oncology sites in Brazil on evidence, not location or promises: documented ethics committee timelines from recent studies, a credible plan for handling the investigational product (IP), and enrollment volume broken down by tumor type, supported by a dedicated coordinator for each study.
November 7, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
I review oncology feasibility from two seats. As chief executive officer (CEO) of bioaccess®, a first-in-human (FIH) contract research organization (CRO) running trials anywhere from Canada down to Argentina, I help sponsors decide where a study can start and enroll. As CEO of Amavita Research Services, a Miami cardiovascular research site operated for seven years with zero United States Food and Drug Administration (FDA) Form 483 findings, I answer feasibility questionnaires from the site side. The questions sponsors ask about Brazil oncology sites are consistent, and they are narrower than most sites expect.
Ethics timelines: document them, do not promise them
The first question is not how fast a site hopes to be approved. It is how long ethics review actually took on its recent studies, and whether the site can document that history.
Every oncology protocol is different, and ethics timelines vary by study. That is exactly why a generic promise helps no one. A sponsor cannot build a startup plan around a verbal estimate, and a site damages its credibility when a promised timeline slips with no record behind it.
What a sponsor can use is a short, documented history: for each of the site's recent oncology studies, the date the submission package went to the ethics committee, the date of approval, and the main reasons for any delay in between, such as additional information requests or consent-form revisions. Sites should document their own ethics timelines in that form and keep the record current, study by study. A site that presents real dates, including the slow studies and what caused the delay, reads as a lower startup risk than a site that presents only its fastest approval.
Sites should also show who owns the submission. Name the person who prepares the ethics package, who tracks questions from the committee, and who turns responses around. Startup speed in oncology is usually a staffing and follow-through question before it is a regulatory one.
Investigational product handling: show the chain, not the storeroom
Oncology protocols place heavy demands on IP handling: temperature-controlled storage, documented receipt and accountability, preparation steps that must happen on schedule, and a clear record of what was dispensed, returned, or destroyed. Sponsors probe this area because an IP failure can invalidate participant data and create a safety risk, not just an administrative finding.
A strong feasibility answer describes the chain end to end. Who receives the shipment and verifies its condition on arrival? Where is the product stored, how is storage temperature monitored, and what happens when there is an excursion? Who is authorized to prepare and dispense, and how is accountability reconciled during the study, not only at close-out? What is the backup plan if the primary person is unavailable on a dosing day?
The answer does not need to be long. It needs to be specific, consistent with the site's standard operating procedure (SOP) set, and owned by named roles. Sponsors and CRO teams compare the feasibility answer against what they see on a site visit and in monitoring. Sites that describe the process they actually run, including its limits, pass that comparison. Sites that describe an ideal process they cannot staff do not.
Training matters here as well. The team handling IP should have current training in Good Clinical Practice (GCP), documented before the study starts, and the principal investigator (PI) should be able to explain oversight of the pharmacy or IP function in plain terms during a selection visit.
Tumor-specific volume: totals do not answer the protocol
The most common weakness in oncology feasibility is volume presented as a single site total. A statement that a center treats a large number of oncology patients tells a sponsor almost nothing about a specific protocol. A breast cancer study, a lung cancer study, and a hematology study draw on different clinics, different investigators, different prior-treatment patterns, and different competing trials.
Sponsors screen by tumor type. For the indication in the protocol, they want to know how many patients the site saw in the last twelve months, how many matched the broad stage and prior-treatment profile the protocol requires, and how many were already committed to a competing study. They want the referral pattern behind those numbers: which departments or outside physicians refer, and how quickly a referred patient can be seen.
Present volume the way a feasibility team can use it: one line per tumor type, with the time period, the source of the count, and the competing studies in the same population. If the number for a tumor type is small, say so and explain the context. A small, documented, reachable population is worth more than a large total that cannot be reconciled when the questionnaire asks for detail.
One dedicated coordinator per study
The fourth signal is staffing. Oncology studies are visit-intensive, documentation-heavy, and unforgiving of delays in safety reporting and data entry. When one coordinator carries several demanding studies plus routine clinic work, the oncology study competes for attention every day, and the competition shows up as slow screening, late data, and missed windows.
Sponsors therefore ask a direct question: who is the dedicated coordinator for this study, and what else will that person carry while it runs? A credible answer names the coordinator, names the backup, and states the other studies assigned to each. It also shows coordinator experience in oncology, not only in research generally, because infusion schedules, toxicity assessments, and response evaluations have their own rhythm.
A dedicated coordinator per study is not a luxury claim. It is the mechanism that makes the other three answers true: ethics questions get answered quickly, IP records stay current, and patients in a specific tumor clinic actually get screened instead of noted and forgotten.
What to send in the first feasibility response
A Brazil oncology site that wants to be shortlisted should be able to attach, in its first response, a compact evidence pack:
- Ethics history: Recent oncology studies with submission dates, approval dates, and the documented reason for any delay.
- IP handling summary: One page covering receipt, storage, temperature monitoring, preparation, dispensing, accountability, and backup coverage, consistent with the site SOP set.
- Tumor-specific volume: Patients seen in the last twelve months by tumor type, with the count source, the broad eligibility profile, and competing studies in the same population.
- Named team: The PI, sub-investigators, the dedicated coordinator for the study, and the backup for each critical role, with current GCP training dates.
- Startup ownership: The named person who owns the ethics submission and the expected internal turnaround for committee questions.
None of this requires a polished marketing deck. It requires records the site should already keep, presented in the order a feasibility team reads them.
The shortlist standard
Sponsors do not shortlist Brazil oncology sites because the country is large or because a site promises effort. They shortlist the sites whose feasibility answers reduce uncertainty: documented ethics timelines instead of estimates, a described IP chain instead of assurances, tumor-specific volume instead of site totals, and a named, dedicated coordinator instead of borrowed staff.
That is the standard we apply at bioaccess® when we evaluate sites for sponsors, and it is the standard I would want applied to my own site. I founded Global Trial Accelerators, a podcast hosted by Jesús E. Moreno for founders and site leaders navigating early-phase development, because these operational details are where trials are won or lost long before the first participant is dosed. Sites that answer feasibility with evidence earn the visit, the selection, and the next study.
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.