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January 15, 2010 (Vol. 30, No. 2)

Virtual Management of Clinical Operations

Novel Web-Based Technologies Can Automate and Facilitate Trial Workflow

  • In 2005, there were 8,386 clinical trials costing nearly $24 billion in the U.S. alone. With clinical development being the longest and costliest phase of drug development, implementing best practices and streamlining processes in clinical trial management is a prime way to improve efficiencies, cut time, and reduce the cost of investigational product development. However, few succeed in maintaining best practices throughout a clinical trial, and potential savings are rarely realized. Much of the cause is the use of technology based on old business models.

    Using technology for technology’s sake under old business models will continue to result in failure to succeed. Traditional processes and function-specific software used by pharmaceutical, biotechnology, and clinical research companies are housed internally but are rarely compatible with each other. Because of parochial silos, turf wars often negate any of the positive improvement that technology and access to all available data can bring.

    As a result, certain technology platforms have been underutilized, leaving sponsors wondering why they invested in nonpaper-based processes with marginal return on investment. The inefficient and unsatisfactory paper-based processes and disparate software tools based on old business models must give way to new era tools that automate and facilitate the clinical trial workflow process, making them more efficient and visible.

    Clinlogix, a global full-service eClinical Research Organization (eCRO), sees the need for the clinical study process to change to help companies be more productive and competitive in this new era of biopharmaceutical and medical device development. To that end, Clinlogix has created a virtual development pathway that incorporates into its services certain new web-based technologies.

    These technologies are based on new business models, further automate the clinical trial management process, and enable efficient project management. Designed to facilitate the clinical trial process, these web-based tools provide access to information, and integrate, connect, report, and deliver valuable project data and milestones and enable better cost management. 

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