News & Events

Outsourcing: How Important are SOPs?

As a laboratory that deals in a specific science, you're perhaps starting to realize it's impossible to do testing on your own without some help. Whether its histology, biotechnology, or the pharma industry, your reputation is on the line if a particular study goes awry due to staff inefficiencies.

Why Preclinical Research is Critical To Drug Discovery For Breast Cancer

Breast cancer is a serious disease that plagues both men and women around the globe. US Breast Cancer statistics estimates that approximately one in eight women will develop invasive breast cancer at some time in their life. There are approximately 240,000 new cases of invasive breast cancer and 61,000 cases of noninvasive breast cancer diagnosed every year. There is no cure for breast cancer as of yet, though there is a significant amount of research focused upon it.

Four Benefits to Outsourcing Your Histopathology: Maintaining GLP to Regulatory Compliance

The Histopathology industry is one that requires exacting study techniques and can suffer exponentially when not having enough capital expenditure. Studying disease and doing pre-clinical research means you have to set a high bar for your reputation, which could easily shatter with one mistake.

The 3 keys to Success in Preclinical Outsourcing: Quality, Speed, and Price

The efficiencies that contract research organizations can gain from outsourcing preclinical histopathology services comes from a mix of organizational principles and industry specific standards. Of these, the three most critical success factors to consider are the quality of the slides and data, the speed and accuracy of completion, and price competitiveness.

The Importance of Archiving Preclinical Histology Slides for FDA Audits

If you are exploring the resources available in support of preclinical histological testing, it is useful to understand how important archiving preclinical histology slides is in creating the context and environment in which it takes place.

A Beginner's Guide to Outsourcing Pathology

Your Beginners Guide to Outsourcing Pathology Services should feature chapters on these three qualities: Efficiency, accuracy and affordability.

Qualifications of Your Contracted Veterinary Pathologist

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:

5 Things a Veterinary Pathologist Needs to Produce a High Quality Report

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:

Preclinical CRO: From Necropsy to Specimen Storage

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.

Preclinical CRO: Delivering Superb Pathology Reports

A quality preclinical pathology report will include critical analysis and interpretation of histopathological and toxicological data, providing the foundation for making a decision on how best to proceed with your preclinical research. Prior to study initiation, it is crucial to ensure that the study pathologist is up to the task of delivering an accurate and comprehensive pathology report. Although, often incorporated as an appendix to the final study report, the pathology report should constitute a stand-alone document that is ultimately responsible for characterizing the preclinical safety of your compound or biologic.

Upcoming Events

SQA

Date: April 6-11
Location: Aurora, CO

ARVO

Date: May 5-9
Location: Seattle, WA

ASGCT

Date: May 7-11
Location: Baltimore, MD

Learn more about StageBio’s COVID-19 response