Managing Clinical Data

摘要

Given the complex regulatory hurdles and high costs, choosing the right computerized system will prove to be crucial to long-term success Regulatory ugencies worldwide are placing ever increasing demands on the pharmaceutical, biotechnology, and medical device communities to demonstrate effectively the safety and efficacy of new health-care products. One outcome of this regulatory environment is an increased focus on the processes involved in clinical trials, specifically those processes that can bealtered to significantly reduce time to market. Paralleling this regulatory trend is the advancement of computerized systems for collecting, storing, managing, and reporting the enormous, near overwhelming clinical and safety data resulting from large clinical studies. What follows is a consideration of factors determining whether small biotechnology companies can use computerized clinical systems.