Abstract

This research surveyed the state of computerized clinical data management across 28 companies attending the April 1989 Drug Information Association Clinical Data Management workshop in Philadelphia, Pennsylvania. It studies clinical trial characteristics, computer systems used, and experience with remote data entry (RDE) and electronic submissions (ENDAs). It also compares 1989 results with previous research done in September 1985. Results: (1) 32% have done RDE, 25% have done an electronic filing, and 14% have done both RDE and ENDA computing; (2) There is no common database software for clinical trials, RDE, or electronic submissions; (3) SAS remains the common analysis software; (4) Clinical hardware systems are equally DEC and IBM; (5) 50% plan to use RDE in the next 6 to 18 months and 39% plan to use electronic submissions in future clinical trials.

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