Electronic Document Management in Clinical Research
Astellas Pharma GmbH, Munich (Germany)
In the following article it is described how the usage of IT systems can help to manage documents in clinical research. Efficient ways to prepare the documents, to manage Trial Master Files (TMF) and Clinical Trial Authorisation (CTA) packages and to capture knowledge contained in clinical research documents are shown. The article is based on the experiences made in a European business unit of a global R&D organisation. In addition procedures and ideas from other biopharmaceutical companies were taken up. The aim of the author was to illustrate “best practices” in the area of document management in clinical research.
pharmind 2007, Nr. 7, Seite 785