Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to commercialization
Below are a few must-ask questions for medtech companies in the market for a CRO that can perform preclinical studies
Are you GLP compliant and/or have a thorough understanding of regulations? Time and again, FDA guidance documents stress the importance of conducting preclinical studies in compliance with 21 CFR Part 58 (Good Laboratory Practices, GLP). A compliant CRO should have appropriate Standard Operating Procedures (SOP) in place, an independent Quality Assurance team, and most importantly, study directors and technical staff that understand the regulations, beginning with a thorough knowledge of the CFR, but also an understanding of the medical device approval process, such as 510K, IDE and CE mark applications, pre-IDE submissions, post submission communications etc.
Is your facility AAALAC accredited and do you have a clean track record with the USDA and FDA? Working with animal models, both small and large, can prove to be very challenging — from anesthesia to post-operative care. A facility that adheres to AAALAC guidelines operates under the highest industry standards in animal care and use, which is a critical starting point for a clean data set for your submission. USDA and FDA routinely inspect CROs to ensure adherence to SOPs, compliance with CFRs, and delivery of clean, unbiased and truthful data. A high quality CRO should have a clean track record with government agencies.
How quick are your timelines? When it comes to device development, you’ll want to minimize, “thousand-dollar days.” After all, costly expenditures can make the difference between profit in loss, or worst-case scenario, can be a death sentence for smaller medical device startups. A good CRO should not only be forthcoming and realistic about timelines on providing you with an estimate, study initiation, reporting and study closeout; but also expeditious. Fast response times, real-time updates, data management and reporting are key to getting your answers quickly. That being said, the emphasis should always be on achieving the highest quality results.
Are you technically and conceptually fluent in my science? An immense amount of work goes into the medical device development process, including input from scientists, engineers, and physicians with unique skill sets. A highly fluent CRO with preclinical experience should understand your science, be able to execute the intent of your device from performing the surgical procedure to administering the drug, and be able to communicate clearly with your entire team: project managers, scientists, engineers, and physicians. The ability to do so not only accelerates the entire process, but also alleviates an administrative burden on the developer’s product manager.
Do you have adequate resources and the ability to source those you don’t? Since 2012, our US-based preclinical lab has archived more than 50 GLP studies for leading medical device manufacturers. Are you evaluating the readiness of your medical device, drug, or biologic for preclinical testing and need feedback from clinicians? Contact us to talk with our preclinical experts.
By carefully evaluating these key factors, you can confidently select a trustworthy CRO partner to accelerate your medical device development – take the first step today and start a conversation with our experts.