Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous, are conducted in compliance with a legally bound code of federal regulations (21 CFR Part 58) and should be conducted by qualified scientists and staff of an accredited contract research organization (CRO). They are also…
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.
“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.” – Innoblative Co-Founder and CEO Tyler Wanke Innoblative seeks to change the game for intraoperative coagulation and ablation of soft tissue via…
Yet another edition of the SEMDA Medtech Conference has come and gone. The 2019 edition saw colleagues from 26 states attend and significant diversity among the PitchRounds companies who hailed from AL, AR, GA, FL, KY, MS, NC, SC, TN, TX and VA. Every year, SEMDA is the place to connect with the entirety of…
GCMI’s 2018 year end review and 2019 look ahead Thanks to our staff, customers, sponsors and fellow industry, academic and philanthropic visionaries, GCMI has tangibly advanced our mission of accelerating the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. 2018 Highlights Leading…
“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.” – Vesalio CEO Steve Rybka Dr.…
As the leading annual electrophysiology event, HRS will always bring the latest advancements in pacing, ablation and mapping to the society’s annual meeting. The 2018 edition was no exception and included a few variations on atrial fibrillation (AF) ablations. Catheter Ablation vs/ Antiarrhythmic Drug Therapy The big news from the show was the dissemination of…
“It is exceedingly rare for student medtech projects to become companies,” Rains said. “But in a very intentional way, and thanks to a robust local and regional medtech ecosystem, that is exactly what is happening here.” Among the approximately 4 million births in the United States each year, 2.4 million of those mothers elect to…
A new medical device’s or product’s pathway from concept to cure to commercialization is fraught with pitfalls, setbacks and usually significant financial investment. T3 Labs prides itself in delivering value-based excellence in what we consider phase 2 of this process, preclinical testing. We are often asked by prospective sponsors for in vivo preclinical studies that…
Grants season is coming up again! Let’s face it, preparing and submitting a biomedical research grant application is a tedious task that requires a lot of planning. We at GCMI-T3 get dozens of requests every year to be collaborators on the preclinical portion of the grant application, often times the night before the grant is…