Are surgical, biocompatibility, toxicology, and pathology services available individually?
How can I determine what tests are required for my device?
FDA and European guidelines are very similar and are approaching harmonization. APS’s team of experts will take a hands-on approach and will walk you through the FDA’s published list of recommended tests. Additional tests may be required on a device-by-device basis. APS can help you determine the needed and best tests to perform; in addition, we recommend that you consult your internal regulatory affairs department or the FDA directly to obtain a complete list of required tests. For biocompatibility studies, APS has developed blanket protocols for the individual tests (assays) contained within ISO 10993 guidance documents.
How can I request a quote or a consultation?
How much lead-time is necessary to initiate a study?
Estimates of lead-times will be provided as quotes are requested. APS is able to develop and initiate small studies within three weeks of quote acceptance. More complex studies involving multiple external laboratories, consultants, or large numbers of test systems may require additional lead-time. Expedited timelines for study initiation and completion can be negotiated on a case-by-case basis.
How often does the APS IACUC committee meet?
The APS IACUC (Institutional Animal Care and Use Committee) meets weekly to review and approve protocols.
Are you ISO certified/GLP compliant?
APS complies with the FDA’s Good Laboratory Practice regulations and is ISO 17025 accredited. APS meets or exceeds FDA standards for data integrity and documentation practices. Read more about our certifications and accreditations.
How confidential will APS keep our proprietary information?
APS is very sensitive to the proprietary nature of each study it conducts. In order to protect its clients’ proprietary information, APS does recommend that a signed CDA (Confidential Disclosure Agreement) be in place prior to any in-depth communication. In addition, APS does everything in its control to keep each study insulated and only available to the client and the APS staff who are directly involved with each study. Every APS employee is trained in clients’ need for confidentiality.
Can/does APS help develop a study protocol?
APS prides itself on helping clients develop thorough and practical protocols that get the job done, while saving time and money. We frequently develop protocols and project plans for unique treatment modalities and novel device designs.
What is the protocol development process?
APS works directly with clients’ teams to develop workable protocols in a collaborative effort. The objective is to document study needs (endpoints), timetables, and deliverables. APS then defines the protocol in writing, which is reviewed by the client, and once in agreement, the protocol is signed off by both parties.
Can we perform a pre-study QA inspection?
APS is happy to host on-site visits and complete the questionnaires required as you search for your preclinical vendor. Please contact us directly if you wish to schedule a pre-study inspection. Our quality-assurance group will respond quickly to all inquiries.
Does APS have an independent quality-assurance team on site?
APS has an independent, full-time staff dedicated to quality assurance. In addition to your study director, each GLP compliant study is assigned a member of the quality assurance team to audit the process, data, and reports.
How qualified are your study directors?
All study directors are BA, BS, MS, PhD level professionals with years of experience in preclinical testing. All directors have backgrounds in biology, toxicology and/or preclinical research. Individual bios are available upon request prior to assignment.
Can APS perform long-term studies with large animals?
APS has capacity for more than 600 large animals and can perform long-term studies of all sizes and species types
What about post-op care?
APS’s team of veterinarians and animal-care technicians provide full monitoring for all animals—pre and post op.
How can I find out the status of my study?
You will have a study director who is available to you during regular working hours via direct contact. He/she will be happy to update you on progress regularly, either on a scheduled or impromptu basis.
Can we use our own physician(s) and/or engineer(s)? Can our team participate?
APS gladly permits the use of qualified outside experts, physicians, and engineers. They are welcome at procedures and are free to assist in the prepping of devices, providing instructions to the implanting physician, and assist in data collection. We request a CV for any participant in the study. If these individuals will be collecting data directly, they may have a training session on APS’s policies and good documentation practices.
Can our team members watch procedures?
All procedure rooms have adjacent viewing suites to accommodate your teams. Cath lab viewing suites are equipped with monitors that will transmit the same information being viewed by the device operator at the table. Team members can also be in the operating suites during the procedures.
Can the procedures be transmitted via video in real time to remote locations?
APS can transmit real-time procedures from each operating suite over the internet. APS has a Quadview system with up to four video leads and a two-way audio channel. Broadcast of Quadview feeds can be done via Vidyo.
Can we just rent lab space or facilities for training?
Yes, APS has operating rooms, Cath lab suites, and wet labs available to rent. APS staff will oversee and participate in equipment and test-system operations on an as-needed basis.
Can you help us source control articles for comparative tests?
Generally, yes. We have accounts with most major hospital distributors and many direct relationships with medical manufacturers. However, any control articles purchased must be used at APS and remain in APS’s control. Not all medical products can be obtained from all manufacturers, and it is very difficult to obtain other off-label use or humanitarian use exemption devices.
Do you provide sterilization services?
APS has steam and ETO sterilization capabilities for early proof-of-concept devices or reusable ancillary equipment. For final devices, the FDA has publicly stated that sterilization should be done in a manner similar to the sterilization methods to be used for clinical-trial products. We do not sterilize finished devices for GLP compliant studies, since this could invalidate the results of the testing.
How many large animals and or small animals can be in a study?
APS has the capacity for hundreds of large or small animals to be used in a single study.