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

We are 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. A high value preclinical CRO understands 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. GCMI’s preclinical testing and bioskills training facilities tick all of those boxes and then some when combined with our Lifecycle Advisory and Design and Development services.

Resources

What makes a good preclinical study final report?

The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a reviewer might be working on. How do you make the report detailed, yet easy to read?

Based on decades of collective experience conducting preclinical studies and writing preclinical final reports, our team details what makes a good preclinical study final report. Read more.

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?

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 preclinical CRO

Medical device innovators need a trustworthy preclinical CRO 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.
  • Cardiovascular

    Our 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 preclinical CRO facility includes a real-life cath lab, high quality operating rooms and all of the equipment needed.

  • Drug & Biologics

    Our preclinical CRO team 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.

  • Orthopedics

    Our orthopedic 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, orthopedic infection, tendon repair/replacement, fracture healing and critical-sized defect models. Our GLP and AAALAC accredited preclinical CRO 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/Urology/GI

    Our general surgical testing experience for preclinical includes gastrointestinal, wound healing and organ transplant to name a few. Our GLP and AAALAC accredited preclinical CRO 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 and Wound Healing

    Our regenerative medicine testing experience includes products for wound healing, cardiovascular and orthopedic applications. Our GLP and AAALAC accredited preclinical CRO 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.

  • Other Therapeutic Areas

    Our 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.

  • Preclinical Facilities & Equipment

    Our preclinical facilities are AAALAC accredited, USDA licensed, and GLP compliant. We operate 32,000 sq ft of operating room, lab, office and vivarium space.

BUYER BEWARE: COMMON COSTS IN PRECLINICAL RESEARCH

All preclinical study estimates are not created equal. We know preclinical studies are expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but not always obvious. A high quality product – data from a preclinical study and the associated final report from your preclinical CRO – are of high value in the medical product lifecycle.

 

What costs you should expect, and what should you watch out for, when planning your next preclinical study to give your product the best chance of getting to market as swiftly and efficiently as possible? Join GCMI CFO & COO Jeffrey White and Preclinical Program Director Matthew Elder in a 30 minute webinar on Thursday, June 18 at 11:00 a.m. Register

In the words of our customers

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Vesalio Finds an Unprecedented Preclinical Partner in GCMI

“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.” – Steve Rybka, CEO of Vesalio

Cell Constructs

Selecting the right preclinical partner: Why Cell Constructs utilizes GCMI

“We cannot think of a better Preclinical CRO to work with and as we continue to add new products to the pipeline, we will certainly utilize T3 Labs for preclinical studies.” – Dr. Tom Barrows, President & Chief Science Officer of Cell Constructs

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GCMI sets gold standard in preclinical testing for CorAmi

“At T3 Labs they have the perfect setup for what we needed. From the cath lab to fluoroscopy to large animal proficiency, not to mention years of expertise specific to cardiology. The entire staff is excited and interested in our technology.” – Dr. Rebecca Levit, Chief Scientific Officer of CorAmi Therapeutics

cardiomems

Preclinical Trials Critical To CardioMEMS HF system: Case Study

“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 at St. Jude Medical

Innoblative SIRA Device

What to do when your GLP preclinical study raises questions

“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective; we learned that we needed to engage the right partners to do that.” – Tyler Wanke, Co-Founder and CEO of Innoblative

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Improving patient outcomes through medtech innovation

“The facilities are top tier. We designed the facilities to make it easy to move from concept through protocol to budgeting and now it happens as efficiently as possible.” – Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc.

Featured Preclinical Stories

Common costs in preclinical research

Preclinical studies can be expensive. Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study that is critical, but not always obvious. What are the most common cost types you should consider when planning your preclinical study? Read on.

Critical elements of high quality preclinical study protocols

Quality preclinical research begins with a robust preclinical study protocol. Preclinical study protocols can make or break a study, and are the foundation on which reports required by regulatory bodies are built. Our team of subject matter experts have outlined what to include in a preclinical study protocol. Read on.

The most expensive study is one you have to repeat. 10 things to know before you start your GLP preclinical study.

Think of your GLP study as a final exam. They follow months, if not years, of “course work.” They can make or break your innovative medical product. Like a tuition bill (including your final exam), GLP studies are costly. Be prepared with everything on our list below, BEFORE you start that study. Click here to read.

Why Choose GCMI as your Preclinical CRO

How do we get preclinical studies right for our customers? Easy access to resources, flexibility, experienced staff, and attention to detail and timelines are the high points. Read more.

What do you do when your GLP preclinical study raises questions?

“This was a make-or-break moment for us. Having credentialed professionals managing the study, board certified veterinarians on staff and a team who cared about the project as if it was their own, is a distinguishing feature for GCMI/T3 Labs.” – Tyler Wanke, Co-Founder and CEO, Innoblative

GLP in 8 days? It is remarkable, but possible with the right preclinical CRO.

Based on our extensive GLP experience, we understood what the sponsor was looking for, what the regulatory body required and then gathered precisely the data that was required in a way that enabled us to generate their report as swiftly as possible: in this circumstance, 8 days. Read more here.

How to Design an Efficient Preclinical Study

When you are confident you are ready for preclinical testing, what gives you the greatest opportunity to make the most of that investment in a preclinical CRO? Click here to learn more.

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