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

Upcoming Connect Opportunity: ASAIO 2023

Evaluating your new artificial organ technology’s readiness for preclinical work or just want to get together to talk about the latest in preclinical testing, bioskills training or medtech innovation across the board? Connect with GCMI and our preclinical CRO T3 Labs at ASAIO 2023.

“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.”

Read on and connect with GCMI & T3 Labs at ASAIO 2023

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 preclinical CRO 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.

In the words of our customers

WHEN CLINICAL RELEVANCE CALLS FOR ON-THE-FLY PRECLINICAL PROTOCOL DEVIATION

“Adopting a protocol that more closely mirrors the actual clinical application in humans, was a high value recommendation brought forth in advance of the in-vivo preclinical work. Working with the great team at T3 Labs has dramatically improved the timeline to test the novel molecules in the clinic, most notably to heart attack patients receiving percutaneous coronary intervention (PCI).”

– Lindon H. Young, Director of the Endocrinology and Introduction to Human Disease and Therapeutics courses in the DO program at the Philadelphia College of Osteopathic Medicine (PCOM)

REGENERATING PACEMAKING CELLS FOR TREATMENT OF CARDIAC ARRHYTHMIAS

““Designing and managing the logistic demands of a large animal study is complex and requires much more knowledge than a bench scientist’s,” he said. “That’s where the team at T3 Labs has been exceptional. They fill in all of the translational gaps for our requirements with very high levels of proficiency. The ability to execute cardiac cath lab preclinical programs combined with electrophysiology is exceedingly rare. T3 Labs has the infrastructure and expertise to make it happen.”

– Hee Cheol Cho, PhD, Urowsky-Sahr Scholar in Pediatric Bioengineering, Associate Professor, Departments of Biomedical Engineering and Pediatrics at Emory and Georgia Tech

ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19

“A good preclinical partner must be able to adapt to the needs, schedule and budget for a specific project. T3 Labs, now part of GCMI, has been an outstanding partner in supporting ALung throughout many preclinical studies.

“Preclinical work is always filled with unexpected outcomes – some good, some bad. Having a trusted preclinical partner that has the experience, expertise, and flexibility to work with your specific product, team, timeline and budget is of the utmost importance.”

– Jeremy Kimmel, PhD, Vice President of New Technologies for ALung

Vesalio_Neva_M1_T_Neurothrombectomy_Clot_Removal_Stent_Retriever

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

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

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

Preclinical Trials Critical To CardioMEMS HF system: Case Study

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

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

Webinar recording: An introduction to the U.S. FDA Investigational Device Exemption (IDE)

THE LATEST: PRECLINICAL IMPLICATIONS FOR EXISTING, AND NEW CIRCULATORY ASSIST DEVICES

What’s the current state of preclinical work for advancements in circulatory assist devices? GCMI’s Michael Sweet recently shared his insights.

Read on.

Cardio Colleagues: Let's Talk Innovation, Including Design, Development, Preclinical Testing and Bioskills Training at AATS 2023.

If you’re evaluating your new cardiothoracic technology’s readiness for preclinical work including pilot studies, evaluating preclinical CROs in general, or if you just want to get together to talk about the latest in preclinical testing, bioskills training or medtech innovation across the board, set up a time to meet up with GCMI and T3 Labs at #AATS2023

Read on & connect.

Let's Talk Innovation, Including Design, Development, Preclinical Testing and Bioskills Training at ASAIO 2023.

If you’re evaluating your new artificial organ technology’s readiness for preclinical work including pilot studies or if you just want to get together to talk about the latest in preclinical testing, bioskills training or medtech innovation across the board, set up a time to meet up with GCMI and T3 Labs at #ASAIO2023

Read on & connect.

ONSITE STATE-OF-THE-ART CT SCANNER ADDS CAPABILITY, EFFICIENCY, TIME AND COST-SAVINGS FOR GCMI PRECLINICAL CUSTOMERS

“The ability for these machines to generate 3D images of anatomic structures and organs in a pre-op, post-op or intra-operative scenario, including cardiac and vascular imaging, has improved the safety and efficacy of scores of new medical technologies.”

Check it out.

Tackling a Standard of Care Treatment Suffering from a 40-70% Failure Rate

GCMI and our preclinical CRO T3 Labs proudly support Georgia Tech BME Capstone projects, including the Fall 2022 effort from Team Wristy Business, taking on an unmet need for scapholunate ligament tears.

Check it out.

Preclinical Implications for Novel Cell and Gene Therapies

What are the preclinical implications for developers of novel cell and gene therapies?

In short, they are a significant departure from the typical preclinical testing requirements to which the manufacturers of these therapies, almost exclusively pharmaceutical companies, are accustomed.

Check it out.

Preclinical Implications for 3D Printed and Bioresorbable Medical Technologies

3D printing and bioresorbable material technologies are actively realizing personalized medicine in the clinical setting improving the lives of patients worldwide.

What, then, are the preclinical testing implications for innovators working with, or relying upon, 3D printed or bioresorbable material technologies?

Check it out.

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical CRO Ecosystem

As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost and improve patient outcomes developed much more recently.

What is the current state of preclinical testing of new medical technologies, drugs and biologics? GCMI Director of Scientific Affairs shares his perspective and insights.

Check it out.

A SCALABLE, CUSTOMIZED SOLUTION TO AN UNMET CLINICAL NEED LONG IN NEED OF INNOVATION

“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a problem we addressed with enthusiasm and with the support and encouragement of Dr. Emily Blum and Dr. Jenelle Foote especially with regard to patient, user and clinical needs.”

Read on.

WHEN CLINICAL RELEVANCE CALLS FOR ON-THE-FLY PRECLINICAL PROTOCOL DEVIATION

“The personnel at T3 Labs has randomized the treatments (test and control agents) and have implemented rigorous study design protocol (e.g. location of area at risk) to enable clear and concise reproducibility of the in-vivo myocardial infarction model to render valid comparisons between the test and control compounds used in the study protocol,” Lindon wrote. “We have completed testing of the first test agent and the results indicate a robust reduction in infarct size (i.e. 70% reduction) in the test compound vs.the control compound group accompanied with significant improvement in post-MI cardiac function.”

Read on.

A SAFER WAY TO CONDUCT PERICARDIOCENTESIS – A PROCEDURE BEGGING FOR A TECHNOLOGY TO REDUCE MORTALITY

“In our tests supported by GCMI and T3 Labs, we found our device reduces pericardial entry depth by over three times less compared to currently available technologies including the 18 gauge needles on the market.”

Read on.

GCMI’S SHERRY FARRUGIA AND MIKE FISHER SHARE IN THE PRESIDENTS’ AWARD OF DISTINCTION FROM CTSA FOR TRANSLATIONAL RESEARCH

“Because of this research collaboration between Georgia Tech, Emory, Children’s and GCMI, one of the biggest problems affecting patient safety in hospital settings might finally be solved.”

Read on.

FEATURED EVENT: AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR

The IDE process allows a limited product release to enable the clinical use of a new device. The trial can then study a device’s safety, efficacy, and usability when there are too many unknowns for a general market release. The market release is constrained for use as prescribed in the clinical trial protocol and limited in distribution in approved institutions. All this is intended to mitigate the risk when studying a novel technology. The IDE is a common, critical activity and waypoint in the path to FDA full market approval.

Join us April 14, 2022 at 11:00 a.m. eastern.

PRECLINICAL SPOTLIGHT: REGENERATING PACEMAKING CELLS FOR TREATMENT OF CARDIAC ARRHYTHMIAS WITH DR. HEE CHEOL CHO

“The more translational we became, the more I understood the lives of the patients who have to live with existing pacemaker technology. “The ability to conduct fundamental and translational studies in small and large animal models in the same location with a highly qualified preclinical staff who understand our needs and our science was the final piece of the puzzle. I distinctly remember flying out of Hartsfield-Jackson that day knowing that this is the place.”

Preclinical support for Georgia Tech researchers' innovative IV Sensor.

“Mabrouk and Inan worked with Patrick Strane, an engineer at GCMI, to figure out how to prepare the device for human testing. After analyzing the device, they decided to make improvements to its packaging, which made it safer for children and more resilient to stringent hospital cleaning standards.”

From Capstone through CREATE-X and on to the precipice of commercialization: Ethos Medical’s medtech journey for its novel spinal guidance system

In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the promising product dubbed Neuraline has evolved to become a new medtech startup: Ethos Medical. The Ethos team leveraged the supporting elements and mentors within the Georgia Tech CREATE-X program—with assistance from GCMI and T3 Labs—to advance development of its needle guidance system.

THE STATE OF PRECLINICAL TESTING IN 2021: A Q&A with GCMI’s Director of Scientific Affairs

What is the current state of the preclinical testing landscape in the United States? GCMI Director of Scientific Affairs Evan Goldberg sheds some light on that question in a Q&A with Write2Market’s Paul Snyder.

WHY GCMI FOR PRECLINICAL TESTING AND BIOSKILLS TRAINING? OUR COMMITMENT TO VALUE

We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice. Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all preclinical programs and RFPs are not created equal. Read on.

WHY GCMI FOR PRECLINICAL TESTING AND BIOSKILLS TRAINING? OUR SCIENTIFIC ACUMEN.

At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA. Let us convince you.

Why GCMI - Quality Compliance Accreditation

WHY GCMI FOR PRECLINICAL TESTING AND BIOSKILLS TRAINING? QUALITY, COMPLIANCE AND ACCREDITATION

GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services. Our AAALAC accreditation and GLP experience validate these claims. But you don’t have to take our word for it. Read on.

WHY GCMI FOR PRECLINICAL TESTING AND BIOSKILLS TRAINING? COLLABORATIVE ACCOUNTABILITY

In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established protocols. What happens if and when a regulatory body returns questions? We won’t turn your project away because it’s too hard, or because we haven’t done it before. We pride ourselves on our interest in your project and our accountability. Read on including a few words from two of our clients.

WHY GCMI FOR PRECLINICAL TESTING AND BIOSKILLS TRAINING? FLEXIBILITY.

As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your surgeons’ availability, not the other way around. We work beyond the bankers hours because we know time is of the essence, deadlines must be met and your innovation is not your surgeons’ sole concern. Read on.

PRECLINICAL TESTING’S ROLE IN THE MEDICAL DEVICE DESIGN AND DEVELOPMENT PHASE

Where does preclinical testing enter the design and development phase of new medical technologies and devices? GCMI Design and Development Director Mike Fisher and Preclinical Program Director Evan Goldberg share deep dive insights.

“At the end of the day, some testing requirements in the design and development phase simply cannot be done ‘on the bench,’ Evan says. “In design input requirements and confirmation activities within the design and development phase, only cadaveric or small scale in-vivo testing can determine if a device provides appropriate grip or traction for the user, or if it works as intended in a beating heart or vessels with blood flow. Read on.

UNDER PRESSURE: CADAVERIC TESTING YIELDS INITIAL HUMAN ORGAN VALIDATION FOR GT CAPSTONE EXPO WINNERS’ MINIMALLY INVASIVE TREATMENT FOR CARDIAC ARREST

“We needed more detail and more evidence on our technology’s potential beyond a porcine heart,” Jackson told us. “We liked what we saw from our early testing, but the access to a cadaveric testing opportunity and support with the GCMI and T3 Labs team was invaluable to our work. With their help, we proved the system can produce the pressure required while inflating at a rate that would not tear the pericardium.” Read more about the Best Interdisciplinary Team in the Fall 2020 Georgia Tech Capstone Design Expo.

Critical preclinical considerations to include in the project planning phase of a new medical technology

Project planning is the beginning of formal product development process, wherein the identified team enters a design control process that complies with medical device regulatory requirements (in the United States, per the FDA) and business strategy. This phase is all about determining the resources, the timing, and the work that’s required for product success.

Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for preclinical work in this early development stage? GCMI Preclinical Program Director Evan Goldberg shares his insights in this Q&A.

How does verification and validation translate to preclinical studies?

Design validation ensures that you have made the “right” product – according to the customer’s needs. Design verification ensures that the team has made the product “right” – according to regulatory and engineering requirements.

How does verification and validation in the design and development process “translate” to preclinical?

Find the insights from GCMI / T3 Labs Preclinical Program Director Evan Goldberg tells us in this Q&A. Read more.

What it takes to keep an industry leading preclinical CRO running right

GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+ years of experience along with his team to keep our industry leading 31,000 square foot preclinical facility performing at the highest of standards for our medtech and life science customers. Read on.

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 and evaluating a preclinical CRO? 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 our preclinical CRO 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.