Title :
Medical CANDAs as a regulatory tool for clinical data review
Author :
Matsiras, P.V. ; Berger, E.T.
Author_Institution :
Merck & Co., Rahway, NJ, USA
Abstract :
Faced with the task of submitting new drug applications and then waiting for the review process to end, a number of firms are participating in computer assisted new drug applications (CANDAs), the information technology exchange experiment between the Food and Drug Administration (FDA) and major pharmaceutical makers. The Merck Medical CANDA is an attempt to improve the situation by developing a PC-based, user-friendly system, under MS Windows 3.0, that facilitates quick access, review, assimilation, and presentation of clinical trial data, for the in-house medical and statistical review of the data, as well as for use at the FDA
Keywords :
government policies; graphical user interfaces; medical administrative data processing; medical computing; Food and Drug Administration; MS Windows 3.0; Merck Medical CANDA; clinical data review; computer assisted new drug applications; data presentation; pharmaceutical makers; statistical review; technology exchange; user-friendly system; Application software; Buildings; Clinical trials; Drugs; Food technology; Information technology; Laboratories; Personnel; Pharmaceutical technology; Safety;
Conference_Titel :
Computer-Based Medical Systems, 1993. Proceedings of Sixth Annual IEEE Symposium on
Conference_Location :
Ann Arbor, MI
Print_ISBN :
0-8186-3752-8
DOI :
10.1109/CBMS.1993.262998
