PSI INTERNATIONAL, Inc. (PSI) provides a broad base of services to our Government and Global
Commercial clients through our Health Science practice, including:
- PSI’s experienced scientists and clinicians facilitate clinical research by offering expert advice in the planning, coordination, and monitoring of all facets of clinical trials.
- Through our support of the Food and Drug Administration (FDA) and the National Cancer Institute’s Cancer Therapy Evaluation Program, PSI has gained an in-depth understanding of the best means to achieve and maintain operational compliance with the published policies and guidance of the FDA, including 21 CFR Part 11.
- We are thoroughly adept at navigating the regulatory process, including developing and processing Investigational New Drug Applications, Adverse Event Reports (AERS), Annual Reports, Investigator’s Brochures, and various legal agreements.
- We have health science personnel who are adept in Medical Dictionary for Regulatory Activities(MedDRA), ICD-9/10, SNOMED, and World Health Organization Drug Dictionary (WHO-DD). Our experience in the historical development and evolution of these medical coding terminologies and dictionaries enables us to utilize them more efficiently and correctly.
PSI has provided technology and mission-oriented support to the FDA continuously since 1988. Over the years, we have gained a thorough understanding of the missions and technical environments of the FDA as well as its Centers and Offices. PSI offers an outstanding blend of subject matter and technical expertise supported by a disciplined management infrastructure and a sound customer centric philosophy. Below we provide a sample of our recent FDA projects.
ADVERSE EVENTS REPORTING PROGRAMS SUPPORT (AERPS)
PSI is highly experienced in operating the Center for Drug Evaluation and Research’s (CDER) Drug Safety Surveillance (DSS) AERPS contract. For more than 13 years, PSI’s medical, information technology (IT), and administrative personnel demonstrated capabilities in processing all of the Adverse Event Reports (AERs) submitted to the FDA, including those received in paper (MedWatchForms) and electronic (E2B) formats from the drug industry and the general public. PSI personnel received, tracked, imaged, performed data entry, and coded all reports into the CDER Adverse Event Reporting System (AERS) database used by the FDA Safety Evaluators.
AERS IT SUPPORT SERVICES (AERS ITS)
PSI has experience managing and maintaining the AERS and the Electronic Submissions (eSub) software applications, including appropriate redesigning where necessary. PSI provided technical and subject matter expertise to implement MedDRA version upgrade releases semi-annually. Complying with the Department of Health and Human Services (HHS) Enterprise Performance Lifecycle (EPLC), PSI has performed various stages of development, including full technical and user documentation.
DOCUMENT CONTROL CENTER (DCC)
For 23 years, PSI provided management, personnel, and technical services for the Center for Biologics Evaluation and Research (CBER) DCC. PSI managed the flow of more than 16 types of highly sensitive documents supplied by over 3,000 blood establishments and biologics manufacturers through the regulatory process, including essential review, approval, circulation, and archive cycles. We operated the records management and communication systems for document and correspondence receipt, retrieval, tracking, circulation control, and disposition.
ESTABLISHMENT EVALUATION SYSTEM (EES)
PSI provides full software development lifecycle support to accomplish the analysis, change requests, requirements definition, system testing, documentation, upgrade and installation of modifications to the EES application, a mission critical application for CDER used to support the drug application review process through submission and tracking of Establishment Evaluation Requests (EERs).