Confidence Beyond Compliance

Our Vigilit® system is a quality-assured environment that accomplishes all the functions related to your legal obligations for literature surveillance. The service has been successfully inspected by MHRA and BfArM. Vigilit® independently performs weekly database searches within PubMed, Embase or other databases. Vigilit® is our web-based solution that can be accessed by any browser / operating system worldwide. You can assign as many users as needed.

After setting up searches in consultation with you (for each substance a search string is created and saved in the Vigilit® system), we continuously monitor the safety literature for your product. Appropriately trained staff is responsible for rating of references in the Vigilit® system for you. Case reports are identified and made available in an automatic push mail for you. Process detected case reports can also be automatically pushed to you in a CIOMS I or E2B-compatible format, if needed. There is a duplicate check performed for all your case reports against cases provided by the Monitoring of medical literature service from EMA (MLM). Other safety relevant literature is also identified for you which can also be feed into our continuous monitoring services. In Vigilit, you can query literature references by category, product name and time interval without additional fees. Vigilit® can be integrated in your current pharmacovigilance system.

We can also support you in managing MLM. Your relevant cases are downloaded from EMA web page and E2B (R2), E2B (R3) as well as a readable file are provided via email on a daily basis to you.

Moreover, we are well experienced in local literature surveillance in multiple countries, which are either covered via our affiliates or our global alliance partner network. You will receive case reports as well as other safety relevant information in English language in addition to a monthly report which documents the searches performed for your products.

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Post authorisation pharmalex