Axella Research is a clinical development venture company offering a unique research model for companies exploring options to further develop their technology for clinical applications and/or regulatory approval through mitigating the financial burden and navigating the regulatory environment. We serve as a strategic partner to assist in expediting clinical research utilizing our SMO/CRO services with both a traditional fee for service model as well as our innovative equity driven model. We have a robust clinical network and a dynamic clinical and scientific advisory board comprised of practicing physicians who understand the practical application and economics of medical devices and drugs that can guide a company with strategic, clinical and regulatory pathways for commercialization of their product. The additional advantage of this model allows us to generate data and qualify proof of concept in new technologies to enable us to engage our group of potential investors for second round financing.
Our network consists of community based physician practices, including a private free standing multidisciplinary cancer center, incorporating medical oncology, hematology, radiation oncology, breast surgery and urology, with additional satellite offices located throughtout the New York area. As a private community based network, we focus on personalized patient care and have experience in conducting phase I-IV clinical trials, with the ability to streamline and expedite accrual of patients. Our core focus is based in oncology and urology with an expanded network of affiliated medical professionals which run the gamut of all medical disciplines.
Our regulatory division consists of an independent CRO which assists in protocol design, strategic planning, IRB approval, FDA submission and study monitoring. Through leveraging our clinical and regulatory expertise, we have the ability to navigate the complexities of the FDA approval process and tap into our clinical network to expedite clinical trials at a tremendous savings to the companies we partner with.
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On a case by case basis, Axella Research may fund the costs of clinical trials and has several capital partners it works with to provide variant levels of funding to companies for the purpose of escalating the development and regulatory process for commercialization of their product.
Biostatistics is a critical element in clinical trials, regulatory submissions, and market promotion. We support this process by providing exceptional consulting services ranging from individual trial design to complete product development programs to support your clinical studies and regulatory submissions.