Preclinical work, especially GLP studies, are costly and critical to the product’s successful regulatory submission. Efficiency and quality in preclinical work begins with a robust preclinical study protocol. Preclinical protocols are the foundation on which reports required by regulatory bodies are built. What elements in a preclinical study protocol give the study the best…
Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The team at GCMI is excited to announce that we will be hosting a series of webinars starting next week. Our first webinar focuses on good laboratory practice (GLP) preclinical…
To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have been focused on how GCMI can lend a hand. Today, I am asking you to help us accelerate our efforts. We are on the frontline of the COVID-19 relief effort. We are part of a…
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. “University research teams and others have been racing to develop DIY ventilators to help patients whose breathing is restricted by COVID-19. Those seeking to 3D-print accessories or parts…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA – March 24, 2020 – Global Center for Medical Innovation (GCMI), the Southeast’s first and only comprehensive medical device innovation center, today announced a collaboration that addresses the severe shortage of personal protective equipment (PPE) for…
WE ARE HERE FOR YOU – Here’s what we are doing during this time to keep business moving forward GCMI remains focused on the health and well-being of our customers and in that spirit we are sharing guidelines for our facilities, recommended by various health organizations as it relates to Coronavirus (COVID-19). As policies and…
Based on decades of collective experience conducting preclinical studies and writing preclinical final reports (both GLP and Non-GLP), our team of subject matter experts has outlined what makes a good preclinical study final report.
As the year comes to a close and many of us look forward to a holiday respite, I find myself full of enthusiasm having recently returned from Israel advancing our accelerator program with Rambam Health Center and participating in the mHEALTH Israel Women’s Meetup at Google for Startups Campus in Tel Aviv. We live in…
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.