Clinical Trial Management and Remote Data Entry on the Internet
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Drug f n f o m f i o n Journal, Vol. 33, pp. 1061-1065, 1999 F’rinted in the USA. All rights reserved.
CLINICAL TRIAL MANAGEMENT AND REMOTE DATA ENTRY ON THE INTERNET ROBERTO SCOGNAMILLO Senior Data Manager and CLint&met Project Leader, Data Management and Statistics Unit, Medical Department, Glaxo Wellcome S.p.A.,Verona, Italy
CARL0 STROZZI Software Engineer, IBM Network Services, IBM SEMEA S.p.A., Milano, Italy
BEATRICE VINCENZI Head of Unit, Data Management and Statistics Unit, Medical Department, Glaxo Wellcome S.p.A., Verona, Italy
GIUSEPPE RECCHIA Medical Director, Medical Department, Glaxo Wellcome S.p.A., Verona, Italy
Despite the widespread use of informution technology and communication advances in the pharmaceutical industry, there are still some steps of the clinical process, such as clinical data collection, that do not take advantage of this technological revolution. In order to verify i f a new technology such as the Internet could both speed data capture and improve the overall quality of data, the Italian Glaxo Wellcome company and IBM have cosponsored a pilot project called CLINical Trial & Research Management via InterNET (CHNT&RNET). Within this joint project, IBM has developed the data capture Internet application and Glaxo Wellcome has handled the clinical and organizational aspects, always in compliance with regulatory laws. This paper summarizes the technical aspects of the project. Key Words: Remote data entry; RDE; Electronic data capture; EDC; Remote data management; RDM; Clinical trials; Internet
INTRODUCTION THE CLINICAL DEVELOPMENT of a drug is a complex and costly process which must be conducted under numerous bonds and regulations. Monitoring clinical studies, in particular, data management, is quite de-
Reprint address: R O ~ I ~ Scognamillo, O Senior Data Manager and Clint&met Project Leader. Data Management and Statistical Unit, Medical Department, Glaxo Wellcome S.p.A., via A. Fleming 4, 37100 Verona, Italy.
manding, both in terms of the time required and the human resources dedicated to this process. Pharmaceutical companies have been trying to improve the overall quality, timeliness, and efficiency of their clinical development processes. Information technology -. offers them an opportunity to do so. In fact, the wrvasive Dresence of innovation due to information -technology is changing the way we work, frequently faster than we would like. Over the last few years- technology companies have proposed many exciting
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R. Scognarnillo, C. Strozzi, B. Vincenzi, and G. Recchia
tools to clinical trial management and data management to improve clinical data capture: interactive voice response, faxed and scanned optical image data capture, smart phones, PC-based remote data entry, and the Internet. Glaxo Wellcome S.p.A. (GW) in Italy and IBM have launched CLINical Trial & Research Management via InterNET (CLINT& RNET), an application to remotely manage clinical trials and capture all patients’ data vi
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