We even do the daily work for you
1. Data entry
Our personnel are specialized in data entry of SAEs/SUSARs and ICSRs as well as any information required for EVMPD. We prefer to work with vigiS3® and vigiDict®. However, we are also familiar with most of the commercially available tools and eager to get into any other tool.
2. SUSAR/ICSR Management
We’ll take care of the complete SUSAR or ICSR management, from receipt to data entry, to classification, to medical evaluation, and to transmission of reportable cases to competent authorities and other receivers.
3. Coding with MedDRA®
We code all the medical terms either within single case reports or bunches of terms from clinical trials and we also provide quality control of already coded terms. Our coding experts are either Certified MedDRA Coders and/or experienced MedDRA trainers.
4. Medical evaluation
Medical evaluation is certainly much more than solely assessing the causal relationship. Our scientists—mostly physicians with profound pharmacovigilance knowledge—are happy to provide in-depth case evaluations.
5. Preparing PSURs, DSURs and other regular reports
We prepare any kind of regular report, such as PSURs, Addendum Reports, SBRs, DSURs etc. Make use of our profound medical knowledge and our long-standing expertise preparing such reports.
6. Signal detection and evaluation
Let us support you in finding the right signal detection method that takes into account the number of cases you are aware of. Let us support you in thoroughly evaluating the signals thus derived and re-assessing the benefit-risk balance of your medicinal products.
7. Risk management plans
Profit from our pharmacovigilance experience in the preparation and maintenance of risk management plans.
8. Clinical expert statements
We prepare the Clinical Expert Statement for your application for renewal of marketing authorizations including comprehensive literature search of the worldwide scientific literature.
9. In-house training
We offer a broad range of in-house trainings: Introduction to pharmacovigilance; MedDRA® for beginners; MedDRA® for advanced users; How to write a narrative. Talk to us about comprehensive training programs for your personnel and any other topic related to pharmacovigilance.