Case Study

Optimizing Process and Task Management

Business Challenges

As a leading Contract Research Organization (CRO), this client has experienced significant growth over the past several years. This growth has placed considerable strain on the organization’s manually intensive business processes and created an operating environment challenged by:

  • Inability to rapidly tailor workflow's to support differing study charter needs and quickly respond to changes in sponsor requirements;
  • A process and technology environment that is inefficient and not easily able to support the company’s strategic intent to expand into new therapeutic areas;
  • Insufficient auditing of workflow actions for CFR Part 11 compliance;
  • A lack of objective metrics to enable accurate assessments of operational effectiveness and profitability.

The ArborSys Solution

Delivering a workflow management solution for this client required careful planning, coupled with a deep understanding of the business processes and the technology landscape. The team worked with the client to:

  • Perform an assessment of the current operational environment;
  • Establish the target process vision;
  • Select “best fit” technologies and support necessary to meet business needs;
  • Develop a phased implementation roadmap focused on incrementally delivering value.​

The project was undertaken in two logical phases:

  • Phase I – System Design and Development: A six-month phase to design, configure, integrate, and validate the application; and establish the governance and support structures.​​
  • Phase II – Implementation and Data Migration: This phase entailed the implementation and migration of all active protocols into the workflow management system.

This custom application integrates to Documentum’s:

  • Content Server – to manage images, protocol, site and subject definitions;
  • eRoom – to provide project team collaboration services.

Value Delivered

The solution allows the organization to proactively manage the broader business processes within and across company boundaries. The system is critical to competitiveness, responsive to business process changes, and achieving higher levels of compliance. The solution has achieved significant tangible and intangible benefits, including:

  • Standardized workflow processes and improved ability to respond to sponsor requirements;
  • Greater efficiencies in tracking, managing and reporting;
  • Ability to proactively manage workloads;
  • Higher levels of CFR Part 11 compliance.

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