The review of the “ICH Topic E6 (R2) Guideline for Good Clinical Practice” and the “Clinical Trial Regulation” (536/2014) in the EU expand on the duties of a study sponsor and to a certain extent also investigators with the basic intent to improve sponsor oversight and quality control. These two closely relate to monitoring and data management which are the topics with the highest number of critical and major findings in the EU in the period from 2000 to 2012 as reported by the EMA.
psiXchange is a reliable, fully automated system allowing for efficient management of reporting obligations, and is used by several of the top twenty contract research organisations and pharmaceutical companies.
Customers are especially delighted by the fact that unlike with rule-based systems and portals the effort for setup and maintenance for SUSAR distributions is reduced by usually at least an order of magnitude. psiXchange can work with any document from any third-party system or any database through a growing set of in- and out-connectors which can be easily adapted to any need for integration with existing data sources. Existing systems as well as existing data are not modified. Integration happens at the data-level.