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| PSI supports the development of new drugs throughout the development lifecycle. PSI's experienced scientists and clinicians facilitate clinical research by offering expert advice in planning, coordination, and monitoring of all facets of clinical trial initiatives. By virtue of our support to the Food and Drug Administration (FDA) and the National Cancer Institute's (NCI's) Cancer Therapy Evaluation Program (CTEP), PSI has an in-depth understanding of the best means to achieve and maintain operational compliance with FDA's published policy and guidance. We have exceptional expertise in navigating the regulatory process, including developing and processing the Investigational New Drug Applications (INDs), Adverse Event Reports, Annual Reports, Investigator's Brochures, Cooperative Research and Development Agreements (CRADAs), Clinical Trials Agreements (CTAs), and other agreement types (i.e., CSA, MTA, CDA). | |
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