Assembling a team for an efficient preclinical study
When it comes to kicking off your preclinical study, assembling the right team will help you anticipate challenges and implement solutions that will help your study progress efficiently, saving you time and resources. In this blog post, we lay out the primary roles you will interact with during this phase of your product’s development.
Sponsor
- The medical product developer
- Initiates and supports a non-clinical laboratory study and submits the study in support of an application for a research or marketing permit
- Range from large, publicly traded companies to startups to individual innovators
Study Director/Principal Investigator/Program Manager
- Scientists with proven capabilities of successfully coordinating and leading preclinical studies, often with significant experience in at least one or two therapeutic areas
- Overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results
- Represents a single point of study control
- Principal investigator plays a similar role, but for a contributing scientist report or non-GLP study
Quality Assurance
- Trained professionals that independently monitor the execution of a preclinical GLP study
- Assure compliance with the protocol and test facility SOPs
- Responsible for monitoring the study to assure test facility management that the facilities, equipment, personnel, methods, practices, records, and controls are in compliance with regulations
Operator/Test Device Evaluator
- In-house veterinarian, a physician, or a third-party with experience performing this type of procedure
- Physician is typically SME
- Working side-by-side with veterinarian is advisable
Veterinarian/Veterinary Personnel
- Demonstrates successful expertise
- Evaluates the health of and care for the animals
- Ensures adherence to USDA, AAALAC, and animal welfare guidelines
Clinical Expert/Key Opinion Leader
- Highly recognized physicians or industry leaders
- Provide instant feedback and expert advice
- Leverage to speed up product development and approval pathway
Contributing Scientists
- Multiple members either from the sponsor’s team, the preclinical CRO’s team, or other facility or lab staff and/or independent subject matter experts
- Includes engineers, chemists, imaging, histopathology, clinical pathology, etc.