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International Clinical Trials

Keeping Tabs

Expiring patents, greater competition and price pressure, together with high regulatory requirements through ever stringent legislation describe the current situation in the pharmaceutical industry.

According to the trend analysis ‘Clinical trial management systems: Business success with modern solutions’ by Pierre Audoin Consultants (PAC), pharma companies are confronted with the challenge of filling their R&D pipelines in order to bring new medicines and active ingredients to the market in short cycles. At the same time, it is necessary to optimise all processes – from development to the production of new medicines – to reduce both cost and risk. In the trend study, PAC points out the seven greatest hurdles in clinical trial management:
  1. Obtaining governmental approvals
  2. Selection and management of sites
  3. Project management
  4. Project performance and control
  5. Time management
  6. Reporting
  7. Management of data and documents


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Jan Klint Nielsen is Senior Project Manager and CTMS Community Manager at BSI, and has been with the company since 2007. He has many years of experience as a project manager of large international projects, and as a department manager of major development and maintenance teams.
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