Literature research and evaluation
Established & successful
According to European and national regulatory requirements, marketing authorization holders are obliged to regularly review the international specialist literature for reports of suspected adverse drug reactions and other information on the benefit-risk profile of their medicinal products or their active substances.
In order to meet this requirement efficiently, we developed a specific literature research service as a pooling project more than 25 years ago.
Here, generally available data relating to active ingredients is shared across companies.
In accordance with GVP Module VI, we now research and evaluate over 900 active substances and active substance groups for human and veterinary medicinal products – chemically defined active substances; herbal active substances; homeopathic active substances – in various databases on a weekly basis.
After the preliminary evaluation of the case reports with regard to “seriousness”, the search results are clustered into “Potential Cases”, “PSUR-relevant” and “Others”.
PhedaLit
The evaluated data is provided and continuously updated in Heacon’s own validated literature database PhedaLit. Thanks to the customer-specific presentation of the evaluated literature citations, the research results can be easily accessed via the online portal.
Automatic notification by e-mail when a relevant case is added to the database ensures that you are always kept informed on a daily basis.
ICSRs, CIOMS forms and “Recommended assessments of drug relation to adverse reaction” can be ordered for published individual cases that require immediate reporting (15-day deadline).
In addition, in view of the legal obligation to prepare PSURs, a corresponding line listing is available for download for each individual case that is to be included in the PSUR.
Studies that should be included in the PSUR are also entered into the database so that the PSUR can also be created easily within the company.
Optional additional services
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 are automatically sent within three working days for each identified individual case, the additional services that can be booked on an individual basis also include back-checks – during the preparation of PSURs or on special topics.
