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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.

Standardization of necropsy techniques is important for consistency and comparability between animals and dose groups. It also aids in minimizing the amount of autolysis that may occur during necropsy, which is particularly important in susceptible organs like the liver, pancreas, kidney and especially the gastrointestinal (GI) tract. An abundance of resident bacteria along the tract leave organs vulnerable to tissue destruction caused by advanced autolysis. Although there will be some low-level, inevitable autolysis that occurs immediately post-mortem, an experienced veterinary pathologist will recognize these intrinsic, enzyme-induced changes and will be able to evaluate the tissues as planned. However, more pronounced artifacts that occur with subsequent, bacterial-derived autolysis could make assessment of pathological tissue changes next to impossible. Precautions should be employed to avoid this detrimental, secondary autolysis during the necropsy; the most effective of which is to shorten the interval between time of death and tissue fixation.

Maintaining integrity at each step in the life cycle of your study materials is the primary responsibility of a contract specimen storage facility. This includes controlling conditions, auditing the facility for GLP preparedness, safeguarding the inventory and offering transparency at every point throughout collection, transport, processing, storage, retrieval and disposal of study materials. A quality facility will work with you to establish the most appropriate storage solutions for your particular needs and plan accordingly to ensure those requirements are achieved. Comprehensive biospecimen storage and management requires that the following considerations be guaranteed.

Making the decision to outsource your preclinical histopathology to a contract laboratory can deliver a myriad of benefits including: the assurance of regulatory compliance; timely and reliable results; and, perhaps most importantly, access to the most highly trained and experienced staff without the cost of hiring and training those individuals in-house. Veterinary pathologists play a key role as team members contributing to drug discovery and safety. To ensure that the veterinary pathologist evaluating your study has the proper qualifications, be sure to ask the following questions:

Successful preclinical research programs rely on board-certified veterinary pathologists to provide critical and accurate analyses pertaining to safety and clinical relevance of the experimental product. To obtain the most comprehensive and high-quality final reports, it is vital to ensure that the study pathologist has access to the most effective support team and most pertinent tools available. Below is a list of items that will provide crucial support to the study pathologist and will ensure the highest quality pathology report:

Market demand for outsourced preclinical research services is growing. Pharmaceutical and biotech companies need contract research organization (CRO) partners who can help them maximize productivity and efficiency in research and development. Faced with a variety of cost pressures, such as patent expiries and more competition from generics, pharmaceutical companies are building strategic relationships with CROs at an increasing rate.

If you’re running a preclinical study that requires histopathology services, you’ll soon discover (if you haven’t already) that high quality histotechnicians play a vital role in making sure your study stays on track. They are responsible for the process of preparing tissues for microscopic examination by a pathologist, who then issues a report on the findings. When high quality slides are delivered to the study pathologist for evaluation, reports can be issued in a timely manner and your study continues to stay on time and on budget.

The objective of the necropsy is to examine the animal macroscopically, identifying any lesions that may help the pathologist diagnose what may have been taking place within the body before the time of death. The prosector will dissect the tissues from the animal and place them in fixative for histology. Once slides have been prepared, the study pathologist evaluates the slides and explains clinical and laboratory findings that may have been found in specific organs. Use of careful and attentive necropsy techniques will yield the most accurate interpretation of results and will ensure that clinically relevant observations are not overlooked.