At Med Communications, we provide full support for pharmacovigilance (PV) projects—from all phases of clinical trials, over spontaneous and solicited post-marketing individual case safety reports (ICSR), to patient support programs, pregnancy registries, and scientific and medical literature reports. We offer our clients complete end-to-end workflow management for their PV activities, including collection, processing, medical evaluation, and single case reporting of adverse events.
Our PV team includes professionals from various medical, pharmaceutical, and academic backgrounds who together offer a broad range of experience and knowledge in the different case processing areas. We assess the validity and seriousness of incoming cases and ensure the timelines for submission to regulatory authorities are met. At the core of case processing, we determine causality as well as listedness according to the reference safety information of the product. In addition to routine case reports of adverse events, we also process special situations, such as pregnancy, overdose, abuse, misuse, lack of effect, and medication errors.
We handle compliant submissions of single cases following the E2B R2 and R3 standards via industry standard gateways. We use state-of-the-art database software, such as Argus and SafetyEasy, to process and report cases to regulatory authorities. Our expertise includes working within the regulatory environments of the United States, with the Food and Drug Administration (FDA), and Europe, with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory agencies worldwide. With a functional PV system in place, our depth of experience gives us the unique opportunity not only to offer our clients support in the markets within which their products are already available, but also to assist during expansion into new markets.
In addition to processing and submitting cases in a high-quality and compliant manner, we conduct reconciliation with teams in other non-PV functions, such as medical information, study teams, quality assurance teams, and other business partners.