Blog
Databases for systematic literature searches
Systematic literature searches are an essential tool of evidence based medicine and as such unavoidable in almost every part of medical research. Their aim is to identify as much available evidence regarding a specific scientific question as possible, by use of a focused, pre-defined and unbiased search strategy.
How a Clinical Trial Management System (CTMS) can improve the quality of your study
As the coordinator or manager of a clinical trial, I have one simple goal: I want my clinical trial to be successful. However, to guarantee success, I need to be able to manage my project efficiently. But what system is suitable for this?
Choosing the right safety reporting workflow for your study
Safety comes first. Always. When planning a clinical project, one of the most sensitive, and coincidentally most important issues, is the establishment of a secure, feasible, functional and effective safety reporting workflow.
Risk-based quality management – the new magic phrase in clinical research
The for mid-2017 expected final version of the ICH-GCP guideline addendum takes the subject risk management to the next level: the extent and implementation of a risk-based quality management for a clinical trial no longer remains within the judgement of the sponsor but actually becomes a legal obligation.
A quick guide to your non-interventional study
Contrary to the outdated image of the non-interventional study (NIS) as a pure marketing instrument, this kind of study is particularly suitable for emphasizing the effectiveness, efficiency and safety of a drug under real life conditions. A quick guide for the planning of your NIS.
Statistical testing in non-interventional studies (NIS)
In this article we would like to address the question whether it is useful to perform statistical testing in the context of a NIS, as it is often requested by the sponsor, and why, if tests are performed, we should handle their results with caution.