What is a Preclinical CRO?

A Preclinical CRO, or preclinical contract research organization, provides the experience, knowledge, and skill required to take a pharmaceutical product or medical device from the drawing board to distribution. This journey entails a plethora of activities that involve scientists, medical personnel, administrators, governmental and industry liaisons, marketing experts, and a host of other technical and creative individuals. Rarely is this unique combination of credentials and craft already present within a sponsoring organization. The CRO industry emerged to fill this much-needed role, to provide the expertise required to bring a pharmaceutical product or medical device into the marketplace as quickly and smoothly as possible.

Because the preclinical period is the most arduous, the phase where many prospective products fail (often due to unrecognized pitfalls in the regulatory process), finding the right CRO is essential. Not only does a sponsoring organization need to enlist the services of a staff knowledgeable in cutting-edge science and technology, well-versed in the ins and outs of governmental and industry regulations and best practices, but find one with a proven track record and a reliably clear and concise communication style. PMI possesses these qualities; we assist you with preclinical research services to proceed to clinical trials in a timely manner and as effortlessly as possible.

Why Conduct Preclinical Research?

Before a new drug or medical device can be tested on humans in clinical trials, it must be tested thoroughly in preclinical trials to make sure it is safe and effective. This often requires testing on animals under the close supervision of veterinary specialists and experts in regulations and ethics pertaining to the use of animals in such studies. Most sponsoring organizations do not have the requisite facilities and staff for this process and so choose to contract research of this kind.

Using a CRO for preclinical research, especially in animal studies (whether disease models or surgical models) helps to insure good laboratory practices (GLP) in all aspects of the study.

Taking a Product from Concept to Completion Requires Specialization

Perhaps the most critical member of a preclinical team is the Study Director. Though the sponsor is in a unique position to know the properties and intent of his or her concept, the path to regulatory acceptance, clinical trials, manufacturing, and post-research reporting and archival is a complex one, a path a sponsor will not necessarily be able to navigate easily.

For example, when conducting animal studies within new drug development, one of the first decisions necessary is the choice of an animal model. In this instance, a PMI veterinarian might be the optimal choice for Study Director in a pharmaceutical testing project. A veterinarian has the expertise to match the appropriate animal model with the product under investigation, the knowledge and motivation to insure the ethical treatment of the animal test subjects, and the in-depth knowledge of all aspects of the preclinical trials to communicate in comprehensible terms to the sponsor so he or she can monitor the study’s progress in the most informed manner and react quickly to any unforeseen need to alter or add to the study plan.

PMI has an excellent record of providing what clients require as part of its laboratory testing and in vivo services—state-of-the-art facilities, an experienced staff easy to work with, the know-how to ease the uncertainties of the process and the acumen to guide the sponsor through regulatory hurdles, and vast experience with both medical device testing and pharmaceutical product research and development.