ALung Technologies granted Emergency Use Authorization by the FDA for their Hemolung® Respiratory Assist System for the Treatment of COVID-19

Accelerator, Blog, Cardiology & Cardiothoracic, GCMI, News, Preclinical CRO Excellence, T3, Uncategorized

A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung® Respiratory Assist System (RAS), the world’s first fully-integrated respiratory dialysis system. This system removes carbon dioxide directly from the blood, allowing the patient’s lungs to rest and heal while avoiding…

Behind the scenes: what it takes to keep an industry leading preclinical CRO running right

Bio-skills and medical device training, Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

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. …

Free webcast: Importance of gross pathology and histopathology in a preclinical study

Blog, Cardiology & Cardiothoracic, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Uncategorized

Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether adverse events were device related. Laboratory veterinarians that write preclinical veterinary reports rely on pathologists to help explain some in-life clinical observations. Regulatory guidance documents also require that preclinical protocols…

“What makes a high quality preclinical study final report?” – FREE Webcast

Blog, Cardiology & Cardiothoracic, Event, GCMI, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Webinar

The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a reviewer might be working on. How do you make the report detailed, yet easy to read? What elements must be present? What common mistakes should you be certain to avoid?…

Buyer beware: Common costs in preclinical research: a free webinar from GCMI

Blog, Cardiology & Cardiothoracic, Events, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3, Webinar

All preclinical study estimates are not created equal: they may or may not include line items that can widely influence the total fee. We know preclinical studies are 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 is not always…

Critical elements of high quality preclinical study protocols

Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, T3

When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already surmounted significant obstacles. They are nearer to realizing the possibility that their product will enter the market and patient care than ever before. Quality preclinical research begins with a robust preclinical study…

Webinar: How to design an efficient preclinical protocol

Blog, Cardiology & Cardiothoracic, GCMI, GI, neurology, News, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, Webinar

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…

Webinar: The most important things to know before you start a GLP preclinical study

Blog, Cardiology & Cardiothoracic, Events, neurology, orthopedic, Physician Innovators, Preclinical CRO Excellence, Regenerative Medicine, spine, Uncategorized, Webinar

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…