Our sponsors’ journey begins with our business development
team comprised of professionals with significant scientific experience and a passion for their areas of expertise, that will 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 significantly more clinically relevant / required for regulatory FDA review? What are the required endpoints, sample size and target anatomy? These are questions that the team will answer together based on many years of preclinical experience, more than over 60 GLP studies archived and 35 products granted regulatory approval. Refinement of the study design with wisely selected endpoints will always lead to quality data. For maximum efficiency, multiple separate studies may have to be initiated to provide clear cut data and stay on top of submission timelines.
Quotes, confidentiality agreements and contracts defining the scope of work and protecting precious intellectual property result from this initial interaction.
The scope or statement of work we expect from our sponsor usually includes
- Species and quantity (if known)
- Deliverables (Type of services, need for final reports, need for histology, etc.)
- Any specialty supplies
The next step is the development of the preclinical study protocol and securing IACUC approvals. The study director or PI will work closely with the sponsor to develop the study protocol that includes the species and quantity along with a rationale for selection, study design, objectives, names of the test and control articles, steps for using the test article, in-life observation requirements, endpoints and data retention.
The execution of the study begins, followed by the delivery of data and reports, QAU and an audit with reconciliations. In a GLP scenario, these data are the backbone of regulatory requirements needed to advance a device or product into the third stage of development.