Data, ECRF, Technical2017-01-17T22:39:39+00:00

Data, eCRF, Technical

A hitchhiker’s guide to data review in an ongoing (“live”) study – part 2: data review for interim analysis

If you are thinking of a clinical trial, you might ask yourself why and how data review for interim analysis can be a topic for a whole article. However, in a non-interventional study there are certain challenges [...]

A hitchhiker’s guide to data review in an ongoing (“live”) study – part 1: data review for pharmacovigilance purposes

In a way, data review for pharmacovigilance purposes is the simplest and yet most demanding kind of data review, as time is a pressing matter in this context. The data are reviewed in different time frames according to the potential risks that arise from them [...]

By |November 8th, 2017|Categories: Data, eCRF & Technical, Safety|Tags: , , , , |

Acting out? Points to consider when planning to involve actigraphy measurements into your study design

From a medical perspective, addressing concepts of physical activity and activity capacity, vital signs (like heart rate or blood pressure), and/or sleep quality in a real-time manner rather than a snap-shot at a visit, make perfect sense and could enrich the value story of novel therapies. However, when planning to involve actigraphy measurements into your study design, there are several points to be considered, including issues of validity, data transfer and data analysis [...]