American Preclinical Services Answers Frequently Asked Questions (FAQs)

Are services available individually - surgical, biocompatibility, toxicology, pathology?

Yes, all APS services are offered a la carte. Biocompatibility, ISR and pathology services are all quoted individually.

How can I determine what tests are required for my device?

FDA and European guidelines are very similar and approaching harmonization. The FDA has published a list of recommended tests. APS’ team of experts can walk you through this list. These are blanket recommendations. Additional tests may be required on a device-by-device basis. APS can consult for you to determine the needed and best tests to perform, or 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 ISO10993

How can I request a quote or a consultation?

You can contact us at 763.717.7990, 877.717.7997, fill out our information request form or send us an email at quoting@apsemail.com.

What happens after a request is made?

Once a request has been made, APS will contact you to execute a Confidential Disclosure Agreement (CDA). After signing a CDA, we will assign an internal contact for you who will be happy to provide initial consultation on program design, model development and testing strategy in support of protocol development. Once a protocol is decided, APS will prepare and offer a proposal for conducting the study.

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 two weeks of quote acceptance. Because APS houses stock test systems, even shorter lead-times are possible under certain circumstances. More complex studies involving multiple external laboratories, consultants or large numbers of test systems may require additional lead-time.

How often does the APS’ IACUC committee meet?

The IACUC (APS Institutional Animal Care and Use Committee) meets weekly to review and approve protocols. Expedited timelines for study initiation and completion can be negotiated on a case-by-case basis.

Are you ISO certified/GLP compliant?

APS complies with FDA’s Good Laboratory Practice regulations and APS is ISO17025 accredited. APS is regularly inspected. APS’ business focus is not directly involved in the manufacturing or release of medical devices, therefore APS is not compliant to ISO13485.

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 require a signed CDA (Confidential Disclosure Agreement). In addition, APS does everything in its control to keep each study insulated and only available to the client and those within APS that are directly involved with each study. Every APS employee is trained in clients’ needs 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, yet save time and money. We frequently develop protocols and project plans for unique treatment modalities and novel device  designs. We like the challenge of “new.”

What is the protocol development process?

APS works directly with clients’ teams to develop workable protocols which is a collaborative effort. The objective is to document study needs (specifications), timetables and deliverables. APS then defines the protocol in writing, which is then 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 onsite visits and complete questionnaires required for APS to be approved as 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 for quality assurance. Each study not only has a study director, but for GLP compliant studies a key member of the quality-assurance team audits 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, animal care, 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 500 large animals and can perform long-term studies of all sizes and species types.

What about post-op care?

APS’ team of veterinarians and animal-care technicians provide full monitoring and 24/7 care 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 on a direct contact basis. 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), 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 assisting 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’ policies and good documentation practices.

Can our team members watch procedures?

All procedure rooms have adjacent viewing suites able 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 Skype or OVOO.

Can we just rent lab space or facilities for training?

Yes, APS has OR, 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 speaking, yes. We have accounts with most major hospital distributors and many direct relationships with medical manufacturers. However, any control articles purchased must be used and remain at APS and in APS’ control. Not all medical products can be obtained from all manufacturers, and other off-label use or humanitarian use exemption devices are very difficult to obtain.

Do you provide sterilization services?

APS has steam and ETO sterilization capabilities for early proof-of-concept devices or reusable ancillary equipment. Flash sterilization cycles can be run. 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 FLP 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.

Take a look inside at the capabilities that APS has to offer...

American Preclinical Services (APS) is a State of the Art, ISO 17025 accredited, AAALAC accredited, USDA registered and GLP compliant Contract Research Organization (CRO) located in Minneapolis, MN.

We are a comprehensive CRO whose catalogue includes ISO10993, USP, USP, JMHLW, custom biocompatibility testing, interventional, surgical, toxicology, pharmacology, pain, cadaver and bioskills, model development and complete pathology services.

Whether your company is a startup or an established industry leader, APS’ experienced staff is uniquely qualified to tackle your project and meet your in-vivo and in-vitro preclinical research needs in a timely fashion. more