In the rush to get new medical devices to market, a process that can rapidly burn through many “$10k days,” unforced errors that result in questions from regulators slow the process even further, causing crises of confidence by stakeholders, and self-doubt. Worse still, once those questions return from regulatory agencies, team members, and investors, the clock starts ticking or accelerates. Medical product innovators must respond with satisfactory answers and solutions, often requiring additional GLP studies, within 30-180 days depending on the type of regulatory submission.
When this occurs, it does not have to cripple a project, provided the innovator engages a preclinical CRO that possesses the staff and expertise to plan proactively, responsiveness to react on decisions, delivering a GLP study from start to finish in no time.
GLP in eight days
While uncommon and remarkable, it is fact that T3 Labs, led by Program Manager Deepal Panchal, accomplished the following in as little as eight days from the start of the study.
- Responded to a Sponsor’s call within the hour,
- Consulted with the Sponsor on a series of FDA questions returned from a regulatory submission for a cardiothoracic device,
- Formed a study execution team,
- Built a plan with the Sponsor,
- Secured all the necessary resources,
- Called a timeout to double check before study-start,
- Executed the study, and
- Produced a GLP report on a two animal acute model. All in as little as eight days from the start of the study.
The stakes were high – missing their window would have resulted in several delays. The sponsor achieved its regulatory clearance within 30 days.
Three main attributes of a preclinical CRO enable this type of responsiveness and success.
1. Surgical expertise
Yes, we can do that. Our relationships with Emory Healthcare, the Georgia Institute of Technology and GCMI (the Global Center for Medical Innovation), Alizee Pathology, CV Path and others bring deep knowledge, access to leading surgeons and training of our internal staff. For the example cited above, T3 Labs swiftly engaged Dr. Ashley Strong, Attending Veterinarian, T3 Labs, who performed the necessary testing procedures by training himself using constructive feedback from the sponsor.
2. Willingness to invest in our own learning
Our preclinical testing and training program leaders are trained scientists, too. As such, we are interested in understanding and participating in the science and methods behind therapeutic options, not only those in the cardiothoracic/cardiology space, but various other surgical/non-surgical models and devices. Learning is a high priority for our own curiosity and supports our preclinical CRO’s mission by advancing the development of innovative therapeutics by providing exceptional quality work to industry and academic collaborators in the biomedical research field.
In this case, T3 Labs provided the training/pilot animals at no cost to the sponsor. We believe the cyclical nature of our sponsor relationships and our commitment to learning provides value to all concerned beyond the bottom line financial contract terms and any individual study of its own.
3. Process/Procedure development and experience yields efficient reporting and deep regulatory knowledge
With more than 50 GLP studies archived and more than 30 sponsor products receiving regulatory approvals, T3 knows how to gather the data required in a way that allows for efficient tabulation and reporting. This is possible due in part to continuous process improvement and constant attention to detail with SOPs, protocols, real-time raw data capture and processing.
In its original form developed at the sponsor’s own lab, the regulatory submission returned with questions regarding an aspect of the study that the sponsor had overlooked in their first GLP study at their internal facility.
Based on our extensive GLP experience, we understood what the sponsor was looking for, what the regulatory body required and then gathered precisely the data that was required in a way that enabled us to generate their report as swiftly as possible: in this circumstance, 8 days.
Talk to T3 Labs about your preclinical medical device testing and training needs.
If your internal lab has reached capacity and can’t accommodate an urgent preclinical need, or if the FDA has questions about your GLP final report for a new medical device or product and the clock is ticking, contact firstname.lastname@example.org or call (404)894-5227. Connect with T3 Labs on LinkedIn.