Anyone developing study protocols and study design knows that components of a thorough safety assessment vary due to any number of factors. The test article or device, route of delivery, and the intended therapeutic application are only a handful of variables that impact how your study is established and executed.

How important are these factors? Unless each one is given careful consideration, the accuracy and usefulness of your research could very well be compromised.

Leave nothing to chance when developing your study protocols and design

The best advice we can give is this: Never risk your research with nonclinical studies that weren’t tailored to meet your program needs and objectives. A nonclinical study has many intricate parts, so it can be easy to overlook some seemingly minute consideration that could have major ramifications on your study results. This is especially true if your team is inexperienced with the practical application of how to run a study.

Even if you or your team members have a background in running nonclinical studies, there can be several scientific considerations that may not be apparent early on. If these considerations slip by without the proper thought required, you may find yourself having to conduct a repeat study.

A high-level view of how we achieve nonclinical study success for our clients

Our pathologists can guide your study design through rigorous protocol and method development, as well as offer scientific considerations support for exploratory non-GLP studies through GLP-compliant safety assessments.

Current specialties include:

• Scientific and Pathology Guidance for Investigational and Feasibility Studies
• General toxicologic pathology
• Medical device pathology
• Neuropathology
• Experimental pathology
• Ocular pathology
• Immunopathology
• Reproductive pathology
• Necropsy    

Using their specialized scientific expertise, StageBio pathologists ensure that your study protocols and design account for the unique variables that impact your study outcomes.

Every study under development has its own blindspots. Our team members combine their diverse backgrounds and skillsets to close the knowledge gaps that threaten your study’s integrity. At the same time, they advise you on optimal sampling approaches and overall study design, allowing you to best achieve your study objectives. In fact, if engaged early enough in the development process, one hour of consultation with StageBio pathologists can identify one or more potential pain points and save potentially hundreds of hours otherwise wasted on addressing those problems after the fact.

Additionally, StageBio provides:

• Tailored pathology evaluations that cover basic guidance, document expectations, and other critical considerations
• Considerations on the nuances of medical devices that may impact tissue response/pathology
• Specialized pathology support for both pathology and scientific specialty areas
• Pathology representation for all pre- and post-submission interactions with the FDA (in person meetings, written responses, etc.)

Don’t risk faulty, misinformed nonclinical study protocols and design

StageBio possesses the knowledge, equipment, and expertise required to eliminate risk from your nonclinical study protocols and design considerations. Get in touch and let’s partner together to optimize your pathology outcomes.