Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to cure to commercialization. Here are a few must ask questions for medtech innovations selecting a CRO to perform your preclinical studies:
- Are they GLP compliant and/or have a thorough knowledge 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 the facility AAALAC/accredited and do they have a clean track record with the USDA and FDA?
Working with animal models, both small and large can prove to be very challenging, right from anesthesia to post op critical care. A facility that adheres to AAALAC guidelines has the highest standards in animal care and use, which is the 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 their timelines?
Device development is always on the fast track. Minimizing the “thousand dollar days” in the medtech development process can make the difference between profit and loss or, in some cases, life and death for a smaller medical device company. A good CRO should not only be forthcoming and realistic about timelines on estimate generation, study initiation, reporting and study closeout; but also expeditious. Fast response times, real time updates, data management and reporting is the key to getting your answers quickly. However, the emphasis should always be on utmost quality of the results.
- Are they technically and conceptually fluent in your science?
An immense amount of work goes into the medical device development process, inclusive of input from scientists, engineers and physicians with unique skill sets. A highly fluent preclinical CRO 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 quickly and 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 they have adequate resources and ability to source those they don’t?
Preclinical studies are resource intensive. Be it equipment, supplies, control articles, surgeons, interventionalists, veterinarians, clinical pathology, histology…the list is endless. An expert CRO should be well prepared and have all the tools and expertise available at their fingertips. You never know what can go wrong during the study, the team should be quick thinking and have resources available to them internally or locally, so they can meet every critical criteria of your study.
Since January 2012, our preclinical CRO has archived more than 50 GLP studies for leading medical device manufacturers of which more than 30 products like Surefire Precision and the CardioMEMS HF system have received regulatory approvals. Every year more than 2,000 allied health professionals train at T3 Labs. Every day we put our skills to work for scores of industry leading medical device companies of all sizes like St. Jude Medical, ALung Technologies, Surefire Medical, Alizee Pathology, ImageIQ and more.
Are you evaluating the readiness of your medical device, drug or biologic for preclinical testing, need valuable feedback from clinicians, or the very best in surgical training for your device? Contact info@t3labs.org or call (404)894-5227.