For numerous clients, we perform the pharmacovigilance screening of medical literature. This service comprises all steps prescribed by the approval authorities, from the development and maintenance of suitable research strategies to creation of reportable data and forms.
Project duration: ongoing
Processing strictly observes the stipulations of the “Guideline on good pharmacovigilance practices (GVP)”. In detail, operations are adapted to specifications or processes already established at the client’s, so that together, we will find as efficient and cost-effective a way as possible.
Screening with regard to drug safety particularly focuses on the following content aspects of the publications:
- undesirable drug reactions
- interactions with other drugs
- administration during pregnancy or breastfeeding period
- administration in childhood
- overdoses / poisonings
- drug abuse / dependency
- therapy failure
- misapplications / errors
- off-label use
- risks / risk factors
- unexpected therapeutic benefit
- occupational exposure
Screening is performed by specially trained GIMD staff, who analyze and process all relevant literature documents in such detail that, if necessary, an individual case report can be generated from them. Depending on client specifications, the documents may also be used for the compilation of “periodic safety update reports”.
This complex type of analysis utilizes numerous ARTIS modules, especially multi-stage full-text analysis and the modules for controlling and documenting procedures. This ensures that even large numbers of documents can be processed within the prescribed short time limits. In order to guarantee the quality and consistency of the analysis results, crucial steps are carried out according to the four-eyes principle. Our quality management (QM) builds on long years of experience in this area and ensures the greatest possible transparency of the processes. The data collected in our QM system is then available for internal and external audits at all times, which simultaneously enables constant improvement and a high reproducibility of screening results.
Another ARTIS module may be used for the semi-automatic execution, e.g. of author enquiries, etc., immensely reducing workloads and effort.