Insight Genetics provides a vast number of established partnerships for our clients, including clinical research organizations (CROs), regulatory experts and contract manufacturing organizations (CMOs), to ease and strengthen assay design and development.
Insight Genetics has also established key partnerships with regulatory experts who have a proven track record to navigate the complicated diagnostic regulatory pathway. We will bring in these partners early in the clinical trial process to ensure open communication with FDA and a smoother regulatory path from pre-submission through PMA.
GLOBAL CONTRACT MANUFACTURING AND COMMERCIALIZATION
Using our preferred partners for global contract manufacturing, we will facilitate custom batch manufacturing and specification setting studies. In addition, Insight Genetics will work with the CMOs and biopharmaceutical companies to develop joint geographical commercialization plans for both the diagnostic and therapeutic.
CLINICAL TRIAL MANAGEMENT COORDINATION
Insight Genetics’ existing partnerships with leading clinical CROs provides our pharma partners with an established working relationship, allowing for the development of a well-structured clinical trial protocol to obtain the data needed for both the New Drug Application (NDA) and Pre-Market Approval (PMA) submissions.