With a shared passion for, and experience in, the field of personalized medicine, Amerimmune implemented their Contract Diagnostics Organization in response to the numerous pitfalls we have personally experienced in the companion diagnostics development process. With our team's extensive experience in managing clinical laboratories, designing and managing clinical research, and navigating the complex regulatory environment specific to diagnostics, we saw the opportunity to fill an unmet need for partnership with the biopharmaceutical and diagnostics industries.
As a result, Amerimmune provides all of the services necessary to develop a companion diagnostic in an integrated, technology-independent manner that stays focused on our customers' business objectives. As a CDO, Amerimmune offers clinical research, a clinical laboratory, manufacturing, and consulting all in one organization - eliminating the need for outsourcing to multiple partners. This also builds in flexibility as well as the ability to implement an efficient, nimble strategy that may naturally shift as development continues.
With inner drives that demand excellence, the belief that there is always more knowledge to be gleaned, and work ethics that leave no stone unturned, the scientists on our assay development team engage in weekly meetings where projects are presented and discussed critically, compared to published literature and talks given at both national and international conferences. All team members participate in extensive training, not only in immunology, but also in flow cytometry as the best panels are designed by individuals who understand both the science and the laboratory technique. Learn more about our team here.
We believe in transparency with our clients, providing all of our assay development, validation, and internal QC data at regular teleconferences. As all projects have both a dedicated project manager and assistant project manager, we make it our goal to respond to any and all questions and/or concerns in a timely fashion, along with providing regular email updates as projects progress. We understand that time is of the essence for our clients and so we do not hesitate from working within their timezone.
Our Quality Management
Our assays undergo rigorous validation, oftentimes exceeding the regulatory guidelines set by CLIA/CAP and the FDA. We make adjustments according to the goals of our clients and the ways in which they plan to utilize our assays, yet even then, we adhere to the highest standards in QM, performing QA and QC steps at every step of assay development and validation, as well as throughout the course of the clinical trial (if our assays are ultimately used in a clinical trial).