Top elements of GCMI’s high-value preclinical services in our customers’ own words 

Finding a trustworthy CRO for preclinical studies is a top priority for medical product innovators. It is always more cost-effective for companies to get it right the first time when selecting data sets, study endpoints and a preclinical partner. In other words, the most expensive study is the one you have to repeat. 

Poorly conducted GLP studies often lead to requests for additional data and delayed regulatory clearance, regardless of the technology’s value or efficacy, not to mention, a huge added expense to the development pathway.

How do we get preclinical studies right for our customers?

Easy access to resources allows for flexibility 

Flexibility and access to resources are key in helping innovators reach their milestones, including preclinical work, on time and on budget. GCMI has tapped into Atlanta’s rich medtech ecosystem and network of healthcare professionals to optimize the product development process and form a team that can easily accommodate for innovators’ specific needs. 

“The Atlanta medtech ecosystem is full of great hospitals and great surgeons,” said Tyler Wanke, Innoblative Co-Founder and CEO. “GCMI did a tremendous job with coordination, scheduling, flexibility and logistics to ensure those doctors felt comfortable and respected in a familiar environment and convenient location.” 

“At T3 Labs they have the perfect setup for what we needed,” said Dr. Rebecca Levit, chief scientific officer for Corami Therapeutics, assistant professor of cardiology at Emory University and adjunct faculty for the Georgia Institute of Technology Department of Biomedical Engineering. “From the cath lab to fluoroscopy to large animal proficiency, not to mention years of expertise specific to cardiology.

“More so, T3 is a very friendly CRO to work with- the entire staff is excited and interested in our technology. I remember even in testing our first prototype- multiple staff members stuck their head in just to say ‘good luck.’ The customer service is what really sets T3 Labs apart from other CRO’s.”

Experienced and knowledgeable staff 

Innovators need to choose a preclinical CRO that is fluent in their science and familiar with regulatory roadblocks. A preclinical study for regulatory submission has very specific criteria, and if not followed correctly can lead to questions.

“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 stated.

GCMI’s preclinical team consists of 40 staff members that include qualified study directors, board-certified veterinarians, surgical and veterinary staff and access to a network of vendors to include qualified histopathologists and clinical pathologists. 

“We have done 7-10 labs with GCMI/T3,” Vesalio CEO Steve Rybka told us. “Every T3 Labs scientist exhibits exemplary levels of professionalism when it comes to interacting with the physicians and associated team members we bring in to conduct our preclinical tests.”

Vesalio started working with T3 Labs as a preclinical partner in 2016 for data collection and proof of concept, in addition to some early onsite prototyping.

“T3 Labs has been a true partner throughout this entire process,” he said. “We understand and are appreciative of the value they bring to development, quality and regulatory processes.”

Attention to detail and timelines 

As many medical device innovators know, one small hiccup in a preclinical study can quickly escalate into a mass of larger issues and be detrimental to the study itself and even the company. GCMI’s independent quality assurance staff ensures that the preclinical team delivers quick results while still maintaining high-quality data. Fast response times, real-time updates, data management and reporting are all key components of our development process. 

For those companies that are conducting an additional preclinical study, deadlines and cost-efficiency become even more important. Innoblative, whose SIRA device utilizes radiofrequency for intraoperative coagulation and ablation of soft tissue, became extremely concerned when their early GLP preclinical studies received a request for additional information from the regulatory body. Highly confident in their technology, the company attributed this unexpected drawback to insufficient attention to detail in their previous study.

Determined to complete their next preclinical study successfully, Innoblative was then referred to GCMI and T3 Labs. 

“We set a very aggressive set of timelines and endpoints,” explained Tyler. “The access to ecosystem resources, the staff qualifications, regimens on veterinary care and all-team coordination were paramount to achieving a GLP 510(k) submission that returned with zero questions asked in a very short timeframe.” 

GCMI/T3 Labs is equipped to meet any of our preclinical needs, whether it be performing a medical device’s early pilot, first GLP study or salvaging what’s left of a previous one. Contact us to learn how we can support your company on the pathway from concept to commercialization.