We offer personalised advice on pharmacovigilance,
from a system description to assuming the role of Graduated Plan Officer.
Assessment of suspected adverse events reported either spontaneously or from clinical trials, safety studies and post-marketing studies:
Medical assessment covers the evaluation of causal relationship and severity of the event. To this end we use the scores developed by Naranjo and Hartwig. We're happy to adapt to the individual requirements of our clients, of course.
In addition to the scoring systems, each case is verbally assessed based on the information available, including classification in line with the latest standards.
We examine whether the event is listed and can be expected or not.
Ultimately you receive a CIOMS form, a corresponding entry in your database or, in future, also an E2B file (xml format).
Review and analysis of scientific literature (single search, periodic searches as legally required):
We can offer one-off searches at specific times, on particular topics or individual adverse reactions.
Periodic literature searches as required legally can be scheduled and undertaken at your specified intervals (weekly, monthly, quarterly).
Results can be reported as protocols listing only the hits with their bibliographical data, or as fully analysed, single cases on a CIOMS form with or without line listing.
If requested, we can summarise the data from published clinical trials in separate data tables, the result of which is a table in the format compliant with point 4.8 of the summary of product characteristics.
Advice for doctors, pharmacists and patients:
You can also appoint us to answer enquiries from doctors, pharmacists and patients concerning your medicinal products or medical devices, beyond mere questions of safety.
Development and maintenance
of risk management plans (RMP):
We can develop RMPs for generic drugs, but can also advise you on risk management plans for pipeline products.
The sooner you contact us, the easier this will be.
Support with the description, implementation and maintenance of your pharmacovigilance system as far as assuming the role of external Qualified Person Pharmacovigilance (QPPV)/Graduated Plan Officer:
We can support you in writing and maintaining standard operating procedures (SOPs) for pharmacovigilance, as well as system descriptions.
Looking for a Qualified Person Pharmacovigilance/Graduated Plan Officer or deputy for these positions? We can gladly assume such a role.
Production of periodic safety update reports (PSURs) or similar documents on clinical trial safety and bridging reports:
You need to write periodic safety reports on your products? We can write them for you, using your data.
The reports are literature-based, but you have no access to literature databases? We can do this research and write the report for you.
Your marketing authorisation is due for renewal? We can systemise your individual safety reports to create a bridging report.
The annual report on your clinical studies needs to be written? We'll gladly help you with this.