Merging Collaboration and Technology: The Virtual Research Organization
October 1st 2003The economic consequences of inefficient work processes in clinical trials are significant. The average daily cost of drug development runs about $30,000 per day and rises by 10% to 12% per year. Development cycle times range from three to 12 years.1 In typical operational practice, the line management of a competitive firm strives to achieve the highest volume of successful new drug application (NDA) submissions (effectiveness) in the shortest practical time (efficiency). This combination reflects the business throughput of an organization.
Biomarkers and Surrogate Endpoints in Clinical Drug Development
July 1st 2003Both large and small pharmaceutical companies have learned that the value of their development candidates increases once clinical research has demonstrated their proof of concept. Sponsor companies face the challenge of moving new blockbuster drugs to market as rapidly as possible.
Planning and Running the e-Clinical Trial
January 1st 2003The interest in exploiting the Internet and its associated technologies to revolutionize the conduct of clinical trials continues to be discussed at length in journals and at conferences.1-4 Although increasing numbers of clinical trials are being commissioned and performed as e-studies, the general take-up is still low when compared with traditional methods. Estimates suggest that approximately 5-10% of all clinical trial data are collected and managed currently as e-trials.5