Curious about the most important things to know BEFORE starting a GLP preclinical study? GCMI has the insight and expertise to answer all of your questions! GCMI has launched a series of webinars hosted by our team members to cover everything you need to know in order to be well prepared for your preclinical GLP study.

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

Our first webinar, featuring GCMI’s Preclinical Program Director Evan Goldberg Ph.D. and Senior Program Manager Michael Sweet, focuses on good laboratory practice (GLP) preclinical studies, which 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). Ensure you are getting your GLP preclinical study and the resulting data right the first time by watching this webinar.

How to design an efficient preclinical protocol

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 opportunity for clarity in a final report that will ultimately be reviewed by regulators? Find out by watching this webinar, featuring GCMI’s Irena Brants and Deepal Panchal!

Buyer beware: Common costs in preclinical research

Medical product innovators need to know much more goes into the making of a high quality, value-based preclinical study. What costs should you expect, and what should you watch out for, when planning your next preclinical study?

In this webinar, GCMI CFO Jeffrey White, Preclinical Program Manager Matthew Elder, and Preclinical Program Director Deepal Panchal help you understand what’s needed – and frequently missing – in preclinical study estimates to properly plan, budget, get it right the first time and give your product the best chance of getting to through preclinical and into regulatory submission.

What makes a high quality preclinical study final report?

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? Dr. Victoria Hampshire, CEO of Capital Preclinical Scientific Research Consulting, Dr. Irena Brants, and Deepal Panchal preclinical program directors with GCMI, sit down to provide insights into elements of preclinical study final reports that reviewers with regulatory bodies will appreciate!


Gross pathology and histopathology in a preclinical study

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 outline methods of assessment to include gross pathology and histopathology. Board certified veterinary pathologists are important contributing scientists for a GLP study.

Marian Rippy, PhD., DVM., DACVP., Jessica Amilcar, DVM and Irena Brants, DVM explore the importance of gross pathology and histopathology in a preclinical study in this 30 minute webinar.