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The Histopathology industry is one that requires exacting study techniques and can suffer exponentially when not having enough capital expenditure. Studying disease and doing pre-clinical research means you have to set a high bar for your reputation, which could easily shatter with one mistake.

The efficiencies that contract research organizations can gain from outsourcing preclinical histopathology services comes from a mix of organizational principles and industry specific standards. Of these, the three most critical success factors to consider are the quality of the slides and data, the speed and accuracy of completion, and price competitiveness.

In the role specimen storage plays in GLP preclinical studies, there is a simple answer; it is at the heart of pharmaceutical research and important to Food and Drug Administration approval for new drugs. However, that statement does need extensive qualification.

If you are exploring the resources available in support of preclinical histological testing, it is useful to understand how important archiving preclinical histology slides is in creating the context and environment in which it takes place.

Your Beginners Guide to Outsourcing Pathology Services should feature chapters on these three qualities: Efficiency, accuracy and affordability.

Do you really know how much capital expenditure you spend on your histopathology services? How about the amount of time you have to put in to manage your projects on a daily basis? If you're not paying attention, both are likely becoming challenging to control considering the complexity of the histology industry. With much of your time and resources going into studying the changes in tissues caused by disease, it's perhaps taking more money than you realize you're spending to keep projects moving forward. It's maybe at a point where you're realizing you've overstepped your boundaries on your budget, and time has become strained due to pressures of getting research done by strict deadlines.

Specimen Storage: Why FM-200 is the Best Fire Suppression System

The entire drug discovery process can be a long and arduous road; each step provides a crucial contribution to the final goal, which is safely and effectively treating patients with an FDA-approved drug. The preclinical phase relies significantly on high quality histotechnology, which comprises the cornerstone of safety and efficacy studies, therefore influencing all further phases of development for the test compound. The path to drug discovery includes the following:

The primary reason for outsourcing preclinical research to a contract research organization (CRO) tends to be consolidation of infrastructure and lowering of fixed operating costs. According to a study conducted by The Tufts Center for the Study of Drug Development (Tufts CSDD), sponsors primarily make the decision to outsource because they believe the CRO is more cost-efficient and time-efficient than internal teams and they want to take advantage of the efficiency and capacity potential that these external players can offer. The study also showed that a sponsor’s primary criterion for selecting a CRO is its reputation to deliver on these cost-savings capacities. The preclinical CRO is therefore under immense pressure to conduct studies and deliver results in a cost-effective and efficient way. Ideally, the facility will have the ability to spread overhead costs, including expert staff and equipment, over a large number of preclinical studies from different clients. But there are several factors that may influence their ability to do just that including: variables related to their own infrastructure, capacity and capability across each unique study and client. Challenges surface when the CRO is spread too thin and can no longer provide individualized focus on the services they provide. When this happens, quality of service falls short and so there is a careful balance for the CRO between taking on the right amount of work and maintaining the highest possible quality of work; but one constant remains: reputation is always on the line.