Literature Research and Evaluation

In accordance with European and national regulatory requirements, marketing authorisation holders are obliged to regularly screen the international scientific literature, on a substance-related basis, for reports of suspected adverse drug reactions as well as other information on the benefit-risk profile of their medicinal products and their active substances.

In order to meet this requirement efficiently, more than 25 years ago we developed a specific literature research service as a pooling project. In this project, substance-related, generally available data is shared jointly across companies.

By now we research and evaluate, in accordance with GVP Module VI, over 900 active substances and active substance groups for human and veterinary medicinal products on a weekly basis – chemically defined active substances, herbal active substances, homeopathic active substances – across various databases. After the preliminary assessment of the case reports with regard to “seriousness”, the search results are clustered into “Potential Cases”, “PSUR-relevant” and “Others”.

The evaluated data is provided in Heacon's own, validated literature database PhedaLit and is continuously updated. Thanks to the client-specific presentation of the evaluated literature citations, the research results can be retrieved easily via the online portal. An automatic email notification when a relevant case is entered into the database ensures that you are always informed up to date.

For published individual cases that require immediate reporting (15-day deadline), ICSRs, CIOMS forms and “Recommended assessments of drug relation to adverse reaction” can be ordered. Furthermore, with a view to the statutory obligation to prepare PSURs, a corresponding line listing is offered for download for each individual case that is to be included in the PSUR. Studies that should be taken into account in the PSUR are also entered into the database, so that the PSUR preparation can also be carried out easily in-house.

In addition to the provision of line listings (Excel format) and XMLs (E2B-compliant files for electronic reporting) and an XML subscription, in which ICSR XMLs for each identified individual case are sent automatically within three working days, the individually bookable additional services include, among others, retrospective searches – on the occasion of the preparation of PSURs or on specific topics.