Especially after a prolonged period of hard work, I find it helpful to step back and look at what I do and how I do it — and consider ways to improve one or both. It’s like going on a retreat, taking some time to rest and reflect — and stay open to unexpected insights and opportunities. Let’s see what’s happening …
Dr. Magnus Lerch Consulting & Coaching is a freelance business that offers consulting services especially for, but not limited to, organizations that work in pharmacovigilance (PV) / drug safety. Here is an overview of the offerings:
Signal Detection and its subsequent processes (Signal Management) are at the core of pharmacovigilance in the pharmaceutical industry, in regulatory authorities (e.g. FDA, EMA), and in other PV organizations like research institutes. Software companies take care of the topic, too: they provide off-the-shelf or custom-made solutions to support Signal Detection.
Finding relevant data in the increasingly huge company/regulatory safety databases is a challenge, especially given the complex nature of safety questions and the high time pressure: answers often have to be delivered immediately, or at least “as soon as possible”.
In a nostalgic mood – Goodbye 2012! – I’ve searched my computer’s hard disk for presentations I’ve created about signal detection in the past. One from 2010 caught my attention, especially two figures I had used to illustrate why computers can help us finding signals in not so small safety data sets.
The first figure represents a small safety data set with 1 drug, 25 MedDRA Preferred Terms (PTs) and 50 individual case safety reports (ICSRs). My message was: “You know them all by name!” – and, hence, probably don’t need a computer to assist you in signal detection. However – given that you only have limited data about the drug – you maybe want to know about signals of other drugs in the same drug class. Then, computers can again be of help as they enable you to look into big publicly available safety data sets.