You have come a long way to get here.
Your device has moved through early concept work, bench testing, human factors and pilot studies. Now the GLP safety study is approaching, and with it, one of the most important preclinical milestones before IDE studies or pivotal clinical trials begin.
Too many sponsors and their selected preclinical partners treat a GLP safety study as the last regulatory hurdle before clinical trials. The best preclinical programs do more than satisfy a submission requirement. They also affirm that risks associated with investigator satisfaction, trial site enrollment, and market adoption have been mitigated to the fullest extent possible.
That difference matters.
By: Jennifer Gordon with Genice Gallegos contributing.
Regulatory compliance is essential, but it is only part of the story. If a study is not designed with clinical translation in mind, the sponsor may still reach first-in-human studies, be those IDE or pivotal trials with incomplete information about procedure timing, workflow, technology or imaging requirements, console placement, staffing needs, human factors, and device behavior in a realistic use environment.
That gap can be especially costly for innovators who assume bench data, in vitro testing, or a less than clinically relevant preclinical setup will be enough. In reality, the preclinical phase, especially GLP studies, is often the last structured opportunity to pressure test the full procedure before it moves into the clinic, and exposed to clinical care in humans for the first time.
The best preclinical work should do more than confirm safety. It should answer practical clinical questions such as:
Those are not secondary details. They are the building blocks of a smooth transition into clinical development and, ultimately, post-market adoption. A well-designed preclinical study provides a key opportunity to generate evidence physicians actually care about – procedural simplicity, ease of learning, procedural time, reproducibility, predictability, durability, complication management – this data captured early on become powerful adoption tools later.
When preclinical study design intentionally mirrors the clinical environment, the resulting data are more useful for downstream planning. The more closely the preclinical OR resembles the intended surgical suite or procedure room, the more confidence sponsors can have that what they are seeing is relevant to real-world use their investigators will experience. This has direct implications for additional investigators needed, trial site enrollment and downstream, post-market adoption.
Bench testing and in vitro work have an important place, but they cannot fully replicate the realities of a living system.
In a live animal model, devices commonly behave or perform differently because the environment is different. Tissue is different. Hemodynamics are different. Anatomy is different. Procedural complexity is different. Something that looks straightforward on the bench can become much more demanding once it is used in vivo.
That is why model selection matters so much. Selection of the animal model should be driven not only by regulatory expectations, but also by the model's ability to support meaningful evaluation of the predefined endpoints and anticipated clinical risks.
For sponsors working with a new or custom model, it is worth asking how many similar models the partner has developed, what validation approach was used, and how the model reflects the intended human use case. Those are not niche questions. They are core questions about whether the study can truly support clinical translation.
From a clinical perspective, that gap shows up in the first human cases including IDE studies or pivotal trials. Veranex SVP of Clinical Research (North America) Genice Gallegos put it plainly: The greatest risk of narrow preclinical thinking is not regulatory delay. It is arriving at first-in-human with unanswered clinical realities that compromise investigator confidence, site adoption, workflow integration, and ultimately patient impact.
The more closely the preclinical environment mirrors the clinical setting where the first-in-human trial will take place, the more valuable the results become. That includes equipment, imaging capability, hemodynamic monitoring, staffing configuration, and the overall setup of the room.
Facility fidelity matters because it affects how the procedure is performed and what the team learns. If the preclinical environment is too different from the intended clinical setting, sponsors may miss workflow issues that could have been surfaced earlier.
This is especially important for interventional technologies where console placement, imaging, procedural flow, and support team coordination can affect both efficiency and user confidence. In other words, the room matters because the room affects the case.
Because the preclinical CRO designs and executes the study, partner selection is one of the sponsor's most important levers. The right questions vet more than a vendor. They help determine whether the partner is simply capable of running a study or is truly equipped to prepare a device for first-in-human success.
Veranex has organized those questions, with guidance on what strong and concerning answers sound like, into a diligence framework for sponsors. Access Evaluating a Preclinical Partner for Clinical Translation here. (Note: We feel this is high value and believe you will find it so as well. As such, it's lightly gated and we ask that you tell us just a little bit about yourself before accessing.)
When preclinical work is designed and implemented well, it creates a cleaner handoff into clinical research including IDE studies and pivotal trials.
Sponsors gain more than a final report to submit to regulatory bodies. They gain procedural intelligence, workflow insight, and better input for investigator training and site readiness. They also reduce the likelihood that their first human cases will uncover avoidable surprises.
That can make clinical trials faster and more successful in practical ways. It can help investigators feel more confident, reduce friction at trial sites, and support a more consistent early clinical experience for patients and users alike.
Just as importantly, it helps preserve momentum. If the first-in-human trial begins with better preparation, there is less need to stop, back up, or revisit questions that should have been answered earlier.
At Veranex, preclinical and clinical research live within the same ecosystem. That matters because it allows the preclinical program to be informed by what the clinical team knows will matter later.
Rather than treating GLP as an isolated event, Veranex approaches it as part of a larger PCS-to-Clinical optimization path. That means sponsors can think about the full journey from study design to first-in-human readiness with greater continuity and less risk of disconnect between preclinical findings and clinical needs.
For innovators that perspective can be the difference between simply getting through GLP and truly preparing for what comes next.
If you are working on a new medical device that must withstand an IDE or classification that demands pivotal trials in humans take a very close look at your potential preclinical partners' capabilities, facilities, experience with your technology and approach to clinical translation. Your prospective customers, patients and growth pathway depend on them more than you might think.
Choosing the right CRO for preclinical testing, especially GLP testing, can be the difference between market success and costly setbacks. Pick a partner who understands both science and strategy including an optimal preclinical model, one who validates their expertise with evidence, not just claims.
About the Author: Jennifer Gordon is Director of Quality Assurance at Veranex Preclinical Services. She is responsible for leading the Quality Assurance Unit (QAU) and ensuring compliance with GLP, OECD GLP, USDA, and AAALAC supporting new and generational medical device development. She possesses 16+ years of program management, process improvement, and Quality Systems experience.
Preclinical Services at Veranex generates the in vivo evidence that clears the way for first-in-human studies. Particularly, though not exclusively, in complex cardiovascular and structural heart technologies like TAVR, Veranex is recognized as a gold-standard preclinical research services provider. GLP and non-GLP studies are designed by device-savvy veterinary surgeons with fast access to Engineering & Development, Manufacturing Solutions, and Biocompatibility, so models, procedures, and endpoints reflect clinical reality from the start. In-house Pathology & Histology delivers integrated interpretations, while Regulatory Affairs and Clinical Research use these findings to shape submissions and optimize trial designs. The result is fewer regulatory questions and a faster path to clinical utility.
About Clinical Research at Veranex - Device-specific trial execution from design through follow-up
Device trials are among the largest investments in a development program, and most of the cost compounds when execution slips. Clinical Research provides end-to-end services for medical devices and IVDs including trial design, site selection, monitoring, data management, and biostatistics. Our device-savvy CRAs understand surgical learning curves, UDI traceability, and ISO 14155 compliance in ways pharma-focused CROs do not. Trials are designed on the strength of Human Factors Engineering, Preclinical Services, and Regulatory Affairs inputs, with endpoints calibrated to satisfy both regulators and payers. Data flows downstream into Medical Writing for CERs and PERs and into HEOR models supporting reimbursement so one partner is accountable from design through post-market follow-up.
Learn more about how Veranex's Preclinical Services and Pathology Services can accelerate your medical device development timeline while ensuring regulatory success from the start. Contact us today to discover how our approach and comprehensive human factors and regulatory teams’ expertise can turn your next FDA pre-submission meeting into a competitive advantage.