Trominosoft LLC is a software solutions company focused on developing Pharmacovigilance software products. Pharmacovigilance is a branch of pharmacological science encompassing all scientific and data gathering activities relating to the detection, assessment, understanding and prevention of adverse events of medicines and medical devices. This includes the use of pharmacoepidemiologic studies. These activities are undertaken with the goal of identifying adverse events and understanding, to the extent possible, their nature, frequency, and potential risk factors. Pharmacovigilance in principle involves the identification and evaluation of safety signals. Safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product’s use.
Postmarketing pharmacovigilance uses tools such as data mining and electronic case report forms to identify the relationships between drugs and adverse drug reactions (ADRs). In brief, an electronic data capture (EDC) system is a computerized system designed for automated support of clinical data collection, reporting, query resolution, randomization, and validation, among other features, in conducting clinical trials. Though EDC technologies offer superior advantages over traditional paper-based systems, collecting, monitoring, coding, reconciling, and analyzing safety data can be challenging.4 To realize the full potential of the information revolution in e-clinical research as compared with traditional paper-based studies, both sponsor and site users will probably have to change the way their offices and days are organized, how they enter and retrieve patient information, how data is entered, the process by which they issue, answer, or close queries, and the ways in which they relate to colleagues and clinical research organizations (CROs) and interact with their patients.
Here at Trominosoft we are committed to developing innovative software solutions for the collection, reporting and analysis of postmarketing pharmacovigilance data.