New Drug Information Association Publication Provides Benchmark for Computerized Systems in Clinical Research
Computerized systems and electronic data management have been embedded into clinical research at a rapid pace in all kinds of applications. However, the clinical research community often underestimates the impact that the use of electronic applications, computerized systems and the transmission of subject data may have on the quality and integrity of data and subject safety.
This latest addition to the DIA library provides a benchmark for requirements of computerized systems used in clinical research. It is intended to support the many users struggling to implement validation processes into clinical research, thus stimulating innovation in the clinical research environment. Proper validation and use of computerized systems will help ensure the safety of subjects and the credibility of clinical research data.
“This book is the result of the exhaustive work of a large group of participants from the global clinical research arena,” says Earl Hulihan, Senior Vice President, Regulatory Affairs at Medidata Solutions Worldwide. “We carefully evaluated and compared the current use of science and technology to define best practices in the design, validation, application and use of computerized systems in the clinical research environment.”
Purchase a copy of Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts. ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.