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Precision medicine clinical trials – How far are we in personalized medicine?
Using precision medicine as an aid to plan clinical trials catches much attention in the present era of drug development. Several innovative precision medicine initiatives have launched clinical trials for complex diseases.
Inform to engage: 4 reasons why patient centricity is not just a buzz word
For successful patient engagement keep information high and live patient centricity throughout your study. How? Let’s explore some approaches by having a closer look at 4 reasons why patient centricity is not just a buzz word.
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.