About Dr. Stephanie Patchev

Manager Business Relations @ GKM Gesellschaft für Therapieforschung mbH

Why the value of on-site monitoring cannot be challenged by remote/ centralized monitoring

This is not to say we should do as we always did. This is also not to promote unnecessarily frequent monitoring visits or a 100% source data verification (SDV). However, in times were risk-based quality management including centralized monitoring are in the regulatory focus, I feel we forget to reflect the undeniable value that on-site monitoring can give to a clinical study [...]

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Contrary to the outdated image of the non-interventional study (NIS) as a pure marketing instrument, this kind of study is particularly suitable for emphasizing the effectiveness,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.

By |2019-07-24T18:04:46+02:00July 22nd, 2016|Categories: Regulatory, Study Design|Tags: , , , |

Game changer for the fight against cancer?

Although not yet brought into daily clinical routine, new screening methods and individualized pharmacological treatment concepts are under evaluation and show promising first results. Three recent findings describe the advances in research for breast, prostate and pancreatic cancer.