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International Clinical Trials

Appointment at the eClinic

Is it merely a matter of time before eClinical solutions are delivering value across the pharmaceutical drug development process? David Laky of eResearchTechnology, Inc, reports

Drug development is an intensely competitive process, and organisations equipped with the best strategy will ultimately take first prize. First prize in this industry is often synonymous with ‘first-to-market’ status, translating into millions of dollars in revenue. Recent breakthroughs offer organisations (be it sponsors, CROs or SMOs) who are conducting or supporting research an equal opportunity to achieve this goal by leveraging technology and managing clinical trials more efficiently through eClinical solutions. An eClinical solution delivers the results originally anticipated from electronic data capture (EDC) by linking sponsors, CROs, physicians and patients into a fully integrated management platform right through the clinical trial.

TRADITIONAL EDC DEFINED

EDC originated from remote data entry software, which developed applications in the life science industry during the late 1980s and early 1990s. As a clinical research tool, EDC promised tremendous advantages over the historically paper process of capturing clinical trial data. Through EDC, data is collected (either electronically or manually) and entered at the respective investigative sites, which greatly reduces subsequent data issues. Once entered, data is subjected to a series of front-end data entry checks. These checks identify and filter out potential errors, thereby limiting the expensive process of correcting data after the site work is completed. Most importantly, EDC provides rapid access to data, enabling sponsoring organisations to begin the process of analysing results, identifying any adverse trends and making critical decisions regarding the potential efficacy of the drug being tested.

There is no disputing that EDC provides real-time access to more accurate data. It also shortens the clinical trial timeframe, automatically generating some level of cost savings. In fact, some industry executives claim EDC has enabled them to reduce 70 to 80 per cent of data errors, going from the investigative site to the sponsoring organisation (1).


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David Laky has more than 15 years’ experience implementing technology solutions across various and diverse industries. For the last seven years, he has been with eResearchTechnology, and currently serves as Vice President and General Manager of the Clinical Data Applications group. Dave graduated with a BSc in Accounting and a Minor in Economics from Pennsylvania State University.
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