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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
“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)
““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
“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
“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
“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
“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
“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
“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
“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.
What’s the current state of preclinical work for advancements in circulatory assist devices? GCMI’s Michael Sweet recently shared his insights.
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
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
“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.”
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.
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.
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?
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.
“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.”
“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.”
“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.”
“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.”
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.
“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.”
“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.”
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.
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.
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.
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.
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.
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.
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.
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.
“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.
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.
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.
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.
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.
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.
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.
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.
“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
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GCMI’s Spring 2023 Capstone Spotlight on Team LifeSTEM “Gliomas are brain tumors that come in multiple forms ranging from low-grade,…
2023 Capstone Team Phantom Lead: a leadless pacing device that utilizes transcatheter delivery for placement in an unconventional location within…
“X-rays supporting our testing at GCMI and T3 Labs clearly showed where the device engaged and the tip aligned at…
Evaluating your new artificial organ technology’s readiness for preclinical work or just want to get together to talk about the…
The National Center for Biotechnology Information describes mechanical circulatory assist devices as, “commonly used in the treatment of severe heart…
“Founded in 1917, the American Association for Thoracic Surgery (AATS), along with its philanthropic arm, the AATS Foundation, has sought…
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“Because we followed a solid pathway, we had a lot more latitude to make positive changes that should increase the…
Quick Insights Aligned in Acceleration: Indeed, the Most Expensive Preclinical Study is the One You Have to Do Twice As…
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Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022…
Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for…
As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to…
“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a…
How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries. During…
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Congratulations are in order! GCMI Chief Executive Officer, Sherry Farrugia, and Director for Product Development Mike Fisher, were among those…
Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022. They’re seeking the southeast’s…
Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization…
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Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed…
According to the American Red Cross, every two seconds someone in the United States needs a blood transfusion. That fails…
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more…
Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February…
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Yoel Alperin, Parth Gami, Sindhu Kannappan and Kelly Qiu comprise the Georgia Tech Spring 2021 Capstone Design Team ScolAlign. Their…
“Our validation work would not have been possible without GCMI’s support and T3 Labs’ facility and equipment. Being ‘radio-opaque’ is…
“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in…
We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also…
At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the…
At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers. GCMI is committed…
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing…
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your…
In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically…
There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24…
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Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for…
Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases…
How does medtech design verification and validation “translate” to preclinical testing? GCMI’s Director of Scientific Affairs explains.
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data…
Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash…
A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use…
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities…
Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies.…
The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not…
All preclinical study estimates are not created equal: they may or may not include line items that can widely influence…
Here are some of the most common cost types you should consider when planning your preclinical study to give your…
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To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have…
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA –…
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Based on decades of collective experience conducting preclinical studies and writing preclinical final reports (both GLP and Non-GLP), our team…
In mid-November 2019, six student-led Georgia Tech Capstone teams put their medical device ideas to the test at GCMI. These…
Georgia Tech biomedical engineering students Oscar Gutierrez, Ahmed Alnamos, Nishani Kanthasamy and Sondos Alnamos make up the team ‘Bullseye’ for…
Aprons of Shield set out to design a device that achieves full-body shielding from radiation for clinicians while still giving…
As the year comes to a close and many of us look forward to a holiday respite, I find myself…
Georgia Tech Biomedical Engineering students Robert Bridenhagen, Gabriel Cruz, and Annika Clawson teamed up with Computer Engineering student Matthew Aspinwall…
Leading Lap has redesigned the trocar’s tip to prevent puncturing or injuring organs upon insertion. Georgia Tech biomedical engineering students…
Thanks to GCMI’s Capstone Day, the team was able to use their device in a highly clinical, practical situation. “Being…
Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous,…
Finding a trustworthy CRO for preclinical studies is a top priority for medical product innovators. It is always more cost-effective…
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“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective;…
At GCMI, medtech and medical device innovation are at the core of our efforts including our work within our industry…
In October 2018, GCMI and Rambam Medical Center announced the formation of a partnership to help Israeli medtech innovators commercialize…
Yet another edition of the SEMDA Medtech Conference has come and gone. The 2019 edition saw colleagues from 26 states…
The American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting is the world’s largest orthopedic conference with over 30,000 attendees annually…
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“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I…
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For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills…
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The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of…
Connect with T3 Labs at AAOS 2017- Booth #1956 The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the…
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For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills…
The Masters of Biomedical Innovation and Development program (BioID program) is a collaborative academic experience in Biomedical technology and a…
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“DDW is the largest annual gathering of surgeons, hepatologists, and gastroenterologists from around the world. The breadth of content covered…
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“I’ve gotten more out of these eight hours than I have in any other training facility.” “This is as close…
Remaining on the forefront of FDA requirements and learning from our peers’ experience is why we invest in the SQA…
“At the conclusion of every program, we depart with a great brand name.”
At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational…
In any medical device training program the stakes are high. The investment in time and money, the relationships with your…
The data driving R&D and commercialization decisions in medtech innovation, like histology, can be underpowered and don’t expound the entire…
ALung recently raised $12 million to support the U.S. regulatory approval process for the Hemolung RAS, the world’s first fully…
At T3 Labs we love to connect with our colleagues at industry leading events year-round. Event engagement not only quenches…
Preclinical testing and training industry leader T3 Labs and imaging and image analysis experts ImageIQ use advanced quantitative imaging to…
A surgeon, a product director and a preclinical study director bump into each other at the Omni Shoreham lobby… Well,…
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in…
ALung Technologies continues to rely on T3 Labs for preclinical research for the Hemolung RAS (Respiratory Assist System) as GLP…
At T3 Labs, we are always eager to meet the collective medtech minds at every conference we attend. What projects…
“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant…
ALung Technologies needed a CRO with great flexibility and responsiveness in order to maximize limited resources and accelerate the timeline…
The past few months at T3 Labs have been immensely productive. Along with our preclinical sponsors we continue to produce…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Atlanta is a hidden gem in the national medical device innovation ecosystem. We recently detailed the top reasons why on…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment…
Surefire Medical achieves FDA 510(k) clearance for direct-to-tumor embolization device Surefire Precision in just 76 days with the help of…
Characterizing nerve response post renal denervation is the most critical aspect of any preclinical renal denervation study. Nerve atrophy, healing…
