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As we've written about recently, toxicology continues to be a demanding scientific field that requires extensive safety procedures and accuracy to maintain reputations. Seeking help from organizations helps immensely in gaining new knowledge and procedures to keep your own lab skills up to date. The same goes for staying compliant to avoid any regulatory fines.

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.

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.

Adhering to a tight schedule is a reality that most contract research organizations (CROs) will face in the preclinical phase of drug development. Managing sponsor expectations and completing the work within strict time, cost and quality constraints can be a challenge and requires adequate experience and resources to succeed. Communicate/Manage expectations Even early on in the project planning stage, both sponsor and CRO can be proactive at mitigating communication fails by ensuring that expectations and responsibilities are explicitly outlined for all team members. The sponsor should communicate company policies and standards explicitly and in writing whenever possible to the contract facility prior to beginning the project. For example, if the sponsor prefers data formatted in a certain way or described in specific language, it is important that the sponsor delineates that up front. A responsive CRO will take heed and ensure that deliverables are structured accordingly. The following issues should be outlined in advanced and communicated clearly to all team members:

The quality of histopathology deliverables is among the most important responsibilities of a preclinical contract research organization (CRO). Results delivered on time and within budget but of a suboptimal quality will never meet the sponsor’s expectations and in reality, wastes valuable time and resources for all parties involved. Challenges can arise when there is a gap in necessary expertise, technology, or other infrastructure necessary to complete the study properly. Outlined below are a few specific areas where challenges frequently arise.