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Challenges Facing a Preclinical CRO, Part 1: Quality

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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.

Experienced Staff

In addition to experience with the various specialized procedures outlined in the study protocol, consistency in quality is mediated by expert staff familiar with preparing and running a preclinical study. One example that highlights the importance of employing an experienced staff in the early stages of the study is animal dosing. Dosing can be a particularly involved aspect of the procedure and is dependent on animal model, type of administration and protocol timeline, among other things. Accurate delivery of the dose is also essential for consistent results and requires an experienced staff to ensure the animals are dosed properly.

One example of the importance of employing an experienced staff in the later stages of the study is histology. The team of histotechnicians working on a given study should be knowledgeable in the anatomy of the chosen animal model. Each team member needs to be well trained in all areas of histology so that the study pathologist is able to make an accurate evaluation without the hassle of reading through poorly processed or missing tissues. Experience and training in ALL areas of preclinical study management is invaluable for consistent, high-quality results across diverse projects and clientele.

Regulatory Compliance

A solid understanding and working knowledge of Good Laboratory Practices (GLP) is essential for a CRO conducting GLP compliant preclinical studies. Internal and external auditing of facilities and documents will help ensure compliance. Moreover, with regulations evolving constantly, it is essential to have an on-site Quality Assurance Unit responsible for monitoring all aspects of the study including: staff, equipment and documentation. An effective Quality Assurance Unit will keep in contact with the industry’s new guidelines and/or best practices as well as keep the facilities GLP compliant.

Management and Team

Sometimes the most state-of-the-art equipment and expert staff still have trouble working together to yield accurate results within a given timeline. When this occurs, an effective management team should be able to intervene and remedy the problem. When this interaction between management and technical team is working smoothly, it is reflected in all aspects of the organization. Most prominently, a smooth internal working relationship manifests itself by the CRO continually providing the highest quality science to its clientele.

Responsiveness

In the dynamic field of drug discovery and development, it is vital that the CRO be transparent and responsive to all client inquiries in a timely manner. Whether implementing a protocol amendment or requesting access to interim data, the efficiency with which client requests are met is a real indication of the quality of the work being conducted and the efficiency of the facility.

Consistency

Running GLP studies is all about consistent, accurate results. This is the key to sound science! Employing qualified staff to handle the workload is of the utmost importance. Planning workload and staff availability will allow you to give each study the necessary time and attention it requires in order for you to produce quality results. An effective team will identify challenges before they become a problem and will implement solutions quickly.


When any or all of the above challenges arise, delivering consistent, high-quality results can become an uphill battle. An established training program should also be put in place to ensure that new members are adequately equipped to join the team and contribute effectively from the start. Comprehensive training will allow for the highest level of employee independence and least burden on management.

Finally, know when to outsource. If hiring and adequately training new staff or investing in new equipment is not feasible at the moment, delegate some of the work to a reputable contractor who has the resources to give your projects the attention they require and who has a reputation for delivering consistent, high-quality results.

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