PSI’s health science services include new drug development support, pharmacovigilance, Tobaccovigilance®, regulatory compliance, drug safety support services, pharmacology, medical coding, MedDRA/WHO-DD implementation consulting, and training. We offer these services to commercial as well as government clients globally.
PSI offers a wide variety of medical coding related services in MedDRA and WHO-DD, including implementation consulting support, coding support, training support, and our eCert Solution. PSI’s coding services expertise is a result of extensive experience in both the regulatory and industry environments.
All of our coding services solutions are focused on ensuring the highest possible coding quality. Our quality focus substantially reduces and often eliminates coding errors, resulting in increased value of the coded information due to the increased accuracy.
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).
PSI’s premier Drug Safety Support Services, DS3, is within our Health Science practice and is the result of many years of experience in providing Drug Safety services and solutions globally. It includes:
PSI offers a wide variety of medical coding related services in MedDRA and WHO-DD, including implementation consulting support, coding support, training support, and our eCert Solution. PSI’s coding services expertise is a result of extensive experience in both the regulatory and industry environments. Many of the lessons we learned in our support of MedDRA and WHO-DD are applicable to other medical coding environments. All of our coding services solutions are focused on ensuring the highest possible coding quality. Our quality focus substantially reduces, or even eliminates, coding errors; vastly increasing the accuracy and value of the coded information.