Managing histology services internally can require a great deal of time and capital expenditure. Outsourcing services such as these continues to increase as clinical and nonclinical laboratories strive to maximize their resources, increase their productivity and expand their capabilities without adding to their workforce.
Here we cover 4 major benefits of outsourcing your histology services.
1. Setting Up a Histology Laboratory Is Expensive
Setting up and running a histology lab takes many resources, the most vital being human resources. A robust technical training program as well as meticulous upkeep of standard operating procedures (SOPs), training documents, equipment maintenance records, and regulatory compliance documents are mandatory to ensure your tissues are being processed according to GLPs and study protocol. Partnering with a GLP laboratory with histology technicians who’ve been properly cross-trained in multiple areas of histotechnique will expedite your study without the long-term expense and management of technical staff.
2. Faster Turnaround Times
Balancing the ebb and flow of sample volume with staffing requirements is a challenge faced by many CROs and lab managers. Clients expect their tissues to be processed on time and with the highest quality. Delays can compromise IND submissions, and ultimately your relationship with the sponsor. Outsourcing histology to a reliable partner with streamlined service offerings can help you get the job done on time.
3. Efficient Use of Project Management Time
Managing the histology portion of a GLP study can be very complex and time consuming, especially for those with little-to-no experience in histopathology. It is critical that each part of the study protocol be followed and the histology portion of these studies be carefully planned. Working with a knowledgeable histology laboratory will not only help you avoid costly mistakes and delays in the timeline, but also decreases the hands-on time required to manage the project.
4. Regulatory Compliance Support
Ensuring that your tissues are processed, evaluated and stored in a GLP-compliant facility is critical. Depending on your project needs or study requirements, you may have to consider the ever-changing regulations of multiple national and international regulatory bodies. When regulatory requirements are not met, unintended issues arise, often in the form of delays and additional resources being spent trying to remedy the situation. The cost and stress of internal regulatory compliance monitoring is minimized when you outsource to a histology lab with the experience to keep your project or study compliant.
When looking for a subcontractor to outsource your histology services to, consider the services they offer and compare both cost and quality factors. Choose a histology laboratory with a track record of clean FDA audits and have technicians with experience providing high-quality services on time and on budget.