Expedited Scheduling of Histology and Histopathology
In today’s drug development environment, many of our clients have critical projects with tight timelines that need to be met in order to advance their programs. This is particularly vital in the pre-IND (Investigational New Drug) phase of a preclinical drug development program. Often, expedited histology and histopathology are requested immediately preceding submission of the IND to a regulatory agency or prior to the initiation of a longer term repeat dose study that depends on the findings of the previous investigation. The decision of when and where to send a study for expedited histology and/or histopathology is frequently prompted by delays in the initial schedule. This is the point at which the work should either be starting or nearly finished, and it highlights the importance of preliminary planning and project management of the client’s workload. Often the client is tasked with completing a study on schedule, while at the same time dealing with competing studies that must also be completed to meet management expectations.
My personal experience in the pharmaceutical and agricultural toxicology industries has taught me that thoughtful and meticulous scheduling on the front end can save a great deal of perspiration, stress and headaches when it comes time for the actual work to begin. I managed this by keeping a calendar of all studies, including an accounting of the various individual study phases (necropsy, histology, histopathology, reports, etc.). This calendar allowed me to anticipate pending bottlenecks and make contingency plans. Weeks and even months prior to the determination that outsourcing the histology/histopathology to a CRO would be necessary, I would begin contacting preferred labs to see who could handle the workload within the required time frame. I would get the requisite quotes for performing this work then make a preliminary decision of where to send it, if truly needed, when the time came.
I would request that the CRO “pencil in” the study on their calendar. As the time for a final decision neared, I would reconfirm the details with the CRO and make a firm commitment to send the study to that organization. If, after preliminary acceptance of my study, that CRO had another client who wanted to send them another study during the same timeframe, I always asked the CRO to contact me. At that point I would confirm my commitment, release the dates, or adjust the dates so the CRO could satisfy the study needs of both clients.
The key to successful contingency planning of histology/histopathology projects is early communication with the CRO. EPL has extensive experience managing multiple histology/pathology projects from clients of varying sizes and with a range of needs. I encourage you to work with us to plan your study needs and schedule them (even with a pencil) to ensure a successful outcome.
Kerry Crabb, HTL (ASCP)
Assistant Manager of NC Laboratory Operations