If you’re coming to APS with one of your first new medical devices, you may be uncertain how your preclinical research plan will unfold.
Perhaps the most important fact to know is that APS approaches each new contract as a partnership — a meeting of the minds aimed at achieving your specific goals as expertly and efficiently as possible. APS works with developers of all sizes, from major pharmaceutical firms to doctor/engineer duos with great ideas (but only basic plans).
That means you can expect a plan customized to your needs, whether your objective is cut-and-dried test results, advice about the next steps in your product development, assistance with FDA negotiations or help with marketing.
“One of the biggest advantages we have is our expertise in problem solving,” advises APS Chief Scientific Officer Mark Smith. “That comes from being in a very productive environment with a high throughput of new device designs and novel programs over the past 15 years. If we see a problem — whether we’re at fault, the client has made incorrect assumptions or the animal model is not appropriate — we use the experience base of our staff and our strong intent to produce the best quality experience for our customers. Over the years, we’ve been incredibly successful in getting to answers while minimizing dollars and time lost.”
Here are other elements to expect when you approach APS for preclinical assistance.
A professional consultation
APS will review your product, your stage of development, relevant and available previous test results, and your current objectives. Some components of consultation may be complimentary based on the client, the extent of information needed and the magnitude of the expected pre-clinical program.
Attention to your project from a core team of professionals
Many of APS’ experts have been part of the organization since its inception. “That’s a great deal of valuable institutional knowledge,” notes Smith. “The broad range of therapeutic areas our study directors and managers have seen is mind boggling.”
Transparency through a detailed plan
An APS-comprehensive study plan details the scope of your research, discusses the animal models involved, states what kinds of results can be expected and provides estimated timeframes for the work. “Various unexpected events can come up to shift timelines,” Smith notes. “For example, a single study might turn into three or four, all associated with refining end points and addressing surprises.”
An honest and accurate cost estimate
This will be based on the stage of your product, the scope of testing required and the level of consultation needed. Smith notes that the costs of early-stage projects can be harder to predict because they include more variables. In general, clients can expect large animal test subjects to cost a minimum of $5,000 per animal per test with costs increasing with overall study duration and increasing complexity.
“APS is approximately at or above the median price for most of the work we do,” he emphasizes. “In my opinion we offer a higher level of service, better quality of infrastructure and significantly enhanced level of experience among our interventionalists that justify the middle-to-high end.”
Partnership for regulatory approval processes
Clients can help APS streamline the testing and regulatory approval processes by presenting their devices after design freeze, and in the finished forms , with product names, labels, sterilization characteristics and other details clearly established. “In general, there’s a lack of knowledge about how strict FDA regulations are for us to be fully compliant,” notes Smith. “It’s just a very high bar.”
Talk to the experienced professionals at APS about how you can make your preclinical research plan as productive, efficient and cost-effective as possible.