How to Design an Efficient Preclinical Testing Study

Our sponsors' journeys begin with our business development team. This team is designed to help you develop your preclinical program, including the optimal model. Selecting the right, clinically relevant in-vivo model is an essential component to the study’s efficiency and quality.

• If a large animal model is needed, are there any species-specific sizing, anatomical, or physiological variables?
• Is one or the other more significantly or more clinically relevant?
• What’s required for regulatory FDA review?
• What are the required endpoints, sample size, and target anatomy?

There are the questions that the team will answer based on many years of preclinical experience. For maximum efficiency, multiple separate studies may have to be initiated to provide clear-cut data, allowing you to stay on top of submission deadlines. Quotes, confidentiality agreements, and contracts defining the scope of work and protecting IP are also a result of this stage.

The scope or statement of work we expect from our sponsor usually includes:

• Species and quantity (if known),
• Timepoints,
• Deliverables (Type of services, need for final reports, need for histology, etc.)
• Supplies

Setting Realistic Expectations in Data Acquisition

We have executed GLP studies to completion in as few as eight days. To be clear, that is the exception, not the rule. We have also executed years-long translational studies in the interest of determining very late responses to new devices versus the current standard of care.

Medical product developers should anticipate the following ranges, even in highly efficient preclinical studies, depending on predicate products, truly novel solutions, and the type of regulatory approval required.

What preclinical challenges are you facing? We know medical device innovation is challenging at every level, in every phase. In addition to our preclinical acumen, especially including preclinical study design, Veranex has end-to-end resources with expertise throughout the commercialization process from the earliest phases like market assessment, human factors and design through regulatory submission, quality control, manufacturing and market access. This ensures wherever you are, you don't have to stop work when "downstream" expertise is needed to inform the work being done today.

Our industry leading preclinical CRO services have supported over 100 regulatory submissions returned with no questions asked.