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European Pharmaceutical Contractor
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As use increases of e-clinical trial systems for the capture, integration, review and correction of data by the clinical trial industry, more and more interest is geared towards the integration of clinical laboratory values, which can represent up to 70 per cent of all the data in some clinical trials. This article is written from the viewpoint of a former manager of central labs who now works to provide pharmaceutical companies with e-clinical trial technology. I begin by looking at where electronic data capture (EDC) and the central lab industry are today. It is obviously early in the adoption cycle, and the issues that need to be resolved include who controls the lab data and the role of standardisation in bringing dependable solutions, to current concerns that clinical trial managers have about integrating lab data with other clinical data in an EDC environment.
What is an EDC Environment?
There are many ways to define the EDC environment. However, EDC generally refers to electronic data capture of so-called electronic CRFs. The standard model is online web EDC, where the staff at a clinical research site have access to eCRFs through the worldwide web. In the standard model, site personnel transcribe data from paper-source documents to eCRFs that appear as electronic forms on web browsers. They also use the web to review and correct clinical trial data.
The advantages of this model are well known; the main ones being online edit checks, ensuring a clear increase in the accuracy of the data collection process and therefore a decrease in the number of queries and in the time required to resolve them. Other advantages are often mentioned, like the faster availability of trial status information for the company, an improvement in project management, or electronic support for remote data monitoring. However, EDC brings these advantages to life only if the site staff use the website to enter data in a timely fashion. If not, these benefits do not exist.
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