Learn How To Successfully Deploy e-Clinical Systems For Use in Clinical Trials in a Regulated Environment
The CR-CSV Working Party is pleased to announce the publication of “Validation and Management of e-clinical Systems in Collaborative Clinical Trials”.
The CR-CSV Working Party is an industry group that has been supporting the clinical research community for 20 years, providing guidance and education on the subject of computerised system validation in clinical trials.
Following the release of the 1st and 2nd editions of the ACDM/PSI “Computer Systems Validation in Clinical Research” guideline it was recognised that there was a growing need in this area for guidance on collaborations between industry partners (such as pharmaceutical companies) and research organisations (such as Academic Research Organisation, Universities and NHS).
These types of collaboration present significant challenges in terms of managing expectations and achieving acceptable levels of compliance to regulatory requirements governing the use of e-clinical systems in clinical trials. The new guideline uses an approach based on worked examples to illustrate the steps needed to ensure that any e-clinical system is trial compliant and inspection ready. These include:
An On Line Questionnaire
Image Analysing Software
Clinical Trial Data Capture
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