Superior access, service, quality and deliverables in a preclinical CRO.

T3 Labs is a trusted, proven industry leading preclinical CRO for medical device and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, safety, and GLP medical device testing for studies in any therapeutic area and in small and large models. Since January 2012, we have archived more than 50 GLP studies for leading medical device manufacturers of which more than 25 products have received regulatory approvals.

What is a Preclinical CRO?

A preclinical CRO (contract research organizations) helps new medical product developers (including devices, drugs, biologics and more) prove those products are safe and effective in live models the FDA deems approximate as closely as possible the human anatomy prior to those devices enter clinical trials (or receiving other approvals like 510Ks) or use for human care.

Top preclinical CROs carry certifications including AAALAC, GLP, USDA registration and Animal Welfare Act compliance. The highest value preclinical CROs understand their customers’ science, have significant numbers of biomedical engineers on staff and are prepared to support those sponsors at multiple inflection points on their pathway from concept to commercialization. T3 Labs and GCMI tick all of those boxes and then some when combined with GCMI’s A1 Accelerator and D2 Design and Development services.

In the words of our sponsors

“T3 Labs is a high quality, dependable, time-sensitive and collegial team with whom we are proud to work. They cover everything you need in a preclinical product, including the right model and pathway to GLP at the right price.”
“We cannot think of a better CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.”
“We value T3 Labs because of the top-notch facilities and expertise,” says Dr. Levit. “We were in need of people with practical experience translating our device beyond the initial idea. It was easy to recognize this unmet need, but I did not understand the complexities that it would take to make it a reality: understanding the market, how to derisk a product, how many studies we would need and what documentation is needed for FDA submission and clearance. T3 is a flexible and efficient environment to work in addition to scientific expertise.”
“We are grateful to T3 Labs for providing access to the facilities and resources the team needed to be ready for our first ever preclinical session with a practicing anesthesiologist,” said Cassidy Wang, co-founder of Neuraline. “There we acquired the customer feedback and functional performance data needed to keep us moving forward efficiently on the complex pathway from concept to commercialization.”
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Vesalio CEO Steve Rybka
“I am convinced this recommendation has accelerated our product refinement testing and preclinical trials, saving ALung time and money at every step along the way,” said Jeremy Kimmel, PhD, ALung’s director of new technology. “Through smart trial and error, we have gone from inconsistent initial outcomes to a position of confidence that we have determined the best protocol to use.”

How to design an efficient preclinical testing study

We are often asked by prospective sponsors for in vivo preclinical studies that are premature. Is the technology successful on bench tests or in vitro? Has a pilot study been performed to verify basic functionality and initial biological response before a GLP study for regulatory submissions? Are there design refinements that could be implemented?

We have saved our sponsors thousands dollars by addressing those issues early and implementing improvements, so that when you are ready for preclinical testing, you have the greatest opportunity to make the most of that investment in compliance with regulatory requirements.

Once it’s “go time,” how do you design an efficient in vivo preclinical testing study? What are the top requirements that give the greatest chances for success? Read more.

Five questions to ask when selecting a CRO for preclinical studies

Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to cure to commercialization. See a few of the must-ask questions for medtech innovations selecting a CRO to perform your preclinical studies here. 

A partner that understands your science and your product development needs

“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans.” – Jason White, Senior Director of Product Development, St. Jude Medical. Read more here

Cardiology

T3 Labs’ cardiology / cardiothoracic preclinical testing experience includes interventional, structural heart, electrophysiology, and renal nerve ablation technologies. Our preclinical, GLP work for leading cardiology/cardiothoracic device manufacturers employs a wide variety of techniques and models tailored to the test article. Our GLP and AAALAC accredited facility includes a real-life cath lab, high quality operating rooms and all of the equipment needed.

Orthopaedics & Spine

T3 Labs’ orthopaedic preclinical testing experience includes spine, large joints, and extremities treated with devices, biologics and cell-based products. Models include, but aren’t limited to: Spine fusion, degenerative disc disease, orthopaedic infection, tendon repair/replacement, fracture healing and critical-sized defect models. Our GLP and AAALAC accredited facility includes high quality operating rooms and all of the equipment needed, including Digital x-ray, Micro-CT, MRI and CT, surgical instrumentation and qualified plastic histology labs. Model development is available.

General Surgery

T3 Labs’ general surgical testing experience for preclinical includes gastrointestinal, wound healing and organ transplant to name a few. Our GLP and AAALAC accredited facility includes high quality operating rooms and all of the equipment needed including ECHO including ICE, TTE and TEE, C-arms and MRI and CT. Model development is available.

Regenerative Medicine

T3 Labs’ regenerative medicine testing experience includes products for wound healing, cardiovascular and orthopaedic applications. Our GLP and AAALAC accredited facility includes high quality operating rooms and all of the equipment needed including cell culture and sorting, C-arms, ECHO including ICE, TTE, TEE, Doppler, IVUS, OCT, Micro-CT, MRI and CT.

Drug & Biologics

T3 Labs has the surgical, veterinary and specialized experience needed to generate positive preclinical results for your drugs and biologics programs. Delivery, dosage, biodistribution and toxicity are the top challenges for developers of new drugs and biologics. Particularly so, for those specific indications where current therapies are underwhelming. Heart attacks, critical limb ischemia, wound healing, stroke and ALS (amyotrophic lateral sclerosis) are a few of the unmet medical needs that will require new, innovative approaches for better treatments and eventual cures.

Other Therapeutic Areas

T3 Labs’ preclinical testing experience in other fields includes dermatology, neurology, and urology.
Dermatology models for preclinical include wound healing in normal or diabetic models and air pouch models.
Neurology models for preclinical include stroke and traumatic brain injury models.
Urology models include for preclinical renal calculi, street urinary incontinence, and embolic delivery models.

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