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Workflow Management Systems for Mid-Size Contract Research Organizations (CROs)

Workflow Management Systems for Mid-Size CROs Addressing the unique challenges and gaining operational efficiencies


Mid-size Contract Research Organizations (CROs) play an important role in the pharmaceutical ecosystem with their focus on quality of service and their ability to specialize in therapeutic areas. These organizations also leverage their low administrative overhead as a competitive advantage. However, the desire to maintain low overhead carries with it an inherent need for efficiency. Senior level managers of CROs face a number of key operational challenges including the following:

  • Maintaining a low administrative overhead while scaling operations
  • Ensuring that all billable hours  are captured in an accurate and timely fashion
  • Reducing the risk of study costs exceeding budget
  • Maximizing staff productivity by providing it with the appropriate tools and resources
  • Maintaining or improving organizational agility by automating certain processes

A well-designed and flexible CRO workflow management system can address all of the above challenges. Automating processes such as the generation of study estimates and quotes, and monthly invoicing can help control the administrative overhead and ensure that it does not scale exponentially with the number of studies. A system that provides Clinical Research Associates (CRAs) and other project staff with “intelligent” timesheets that are easy to use ensures that billable hours are recorded accurately. Real-time visibility into the study costs, budgets, and revenues empowers senior management to make the right decisions regarding resource allocation and to engage discussions with clients before study costs exceed budget. Finally, providing staff with a system that is easily accessible from both the office and remote locations improves productivity and helps ensure user acceptance of the system. A well-designed workflow management system also takes into account the organizational culture of a CRO by implementing processes without adding levels of bureaucracy.


The authors of this paper will present a case study around this article at this live webinar “eClinical Choices for Small to Mid-Size Companies”.

Prasad Sristi is Founder, President Mindprint Inc., and Ron Kolanitch is Corporate Director of Business Development, ethica Clinical Research Inc.


 Contract Research
 Workflow Management
 ERP systems

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