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