White Papers

An Introduction to electronic Patient Diaries

The use of electronic Case Report Forms within clinical trials is growing but less is heard about Patient Diaries.

Predicate Rules - Part I

The eClinical regulatory framework often causes confusion; in particular terms like 'predicate rules'. This white paper, the first in a two part series, discusses the US and European regulations.

Predicate Rules - Part II

The regulations sometimes seem like a jigsaw puzzle with some of the pieces missing. This paper distils the US and EU regulations into 22 areas for consideration by those needing to comply.

Clinical Data Archive

This white paper investigates the use of the CDISC ODM for archive purposes and whether the model meets the ten critical success factors essential for successful long-term storage of clinical trial data.

The Software Development Life Cycle

Developing high-quality software is fraught with difficulties. Successful software projects rely as much on clear requirements, organisation and discipline as the development methodology chosen.

How to Write Better Requirements

Requirements provide the solid foundations for the development process. Without them, a project is built on shifting sands. This white paper explores the characteristics of a good set of requirements.

Source Data and electronic Patient Reported Outcomes

Recent events have put eSource back on the agenda and, in particular, the use of electronic Patient Reported Outcomes. This white paper outlines the issues.