Improving interorganizational data interchange for drug
Kip Can®eld *
Laboratory for Healthcare Informatics, Department of Information Systems, University of Maryland, UMBC, 1000
Hilltop Circle, Baltimore, MD 21250, USA
Received 1 June 1998; accepted 24 November 1998
This paper presents a reengineered process that uses a markup language to do interorganizational
data interchange between the participants in the US drug development process. The two major goals of
this paper are to present (1) a detailed enough description of the reengineered version of this process
that a practitioner will be able to use it and (2) a case-study of the reengineering of an
interorganizational data interchange system that is applicable to other areas in health care. The detailed
description is augmented with a companion web-site that shows all programs in a working prototype.
The case-study uses an IDEF0 model to show the structure of bene®ts from markup standards for
interorganizational data interchange. # 1999 Elsevier Science Ltd. All rights reserved.
Keywords: Electronic data interchange; Pharmaceutical research; XML; Standards; IDEF0
The approval of a drug product by the Food and Drug Administration (FDA) is an
interorganizational process involving several companies and the FDA. For example, a research
®rm (contract research organization or CRO) might do the clinical studies for a sponsor
pharmaceutical ®rm and then this sponsor will forward all data to the FDA in an application
(such as a new drug application or NDA). This has traditionally been done with very large
shipments of paper (many thousands of pages) from the sponsors to the FDA. Recently,
Computers in Biology and Medicine 29 (1999) 89±99
0010-4825/99/$ - see front matter # 1999 Elsevier Science Ltd. All rights reserved.
PII: S0010 - 4 8 2 5 ( 9 8 ) 0 0 048-1
* Tel.: +1-410-455-2649; fax: +1-410-455-1073; e-mail: can®email@example.com.