Case Study

Biotech firm launches clinical decision support system on schedule and under budget.

Design and development of clinical decision support system was completed ahead of schedule and under budget. The project included the development of new reporting system that enabled company to track clinical trials for new drug.

Company

The client is a global leader in biopharmaceuticals and focuses on discovering, developing, manufacturing and delivering human therapeutics.

Challenge

The company needed to develop a decision support system within 6 months to support the development, testing and manufacturing of a new drug through stage 2 clinical trials. The project included the design, development and testing of over 40 complex reporting applications within a validated system environment. The objective was to meet all corporate and regulatory requirements and deliver within 6 months and a set budget. Without the resources to develop such a system, 3 Key Consulting was brought in after the project was initiated to provide expertise and execute the project. There were regulatory requirements and a looming deadline. Additional challenges included:

  • Limited internal resources
  • Multiple source systems requiring resources with multiple domain expertise
  • Validated environment with stringent testing and QA processes
  • Complex statistical computations.
  • Complex formatting requirements.

Solution

Working with the client, key personnel, and various stakeholders, a collaborative team was established to rapidly assess staffing needs, issues, challenges, and high-level internal and regulatory requirements. 3 Key then brought in seventeen IT professionals specializing in SAP, Informatica, Business Objects reporting and universe design, business analysis, project management and quality control to expedite the project. The team worked with three client resources who were dedicated to the project on a part time basis only. 3KC worked directly with the business and other support groups to drive the project forward. The project was accelerated cost effectively with superior project management and system architecture expertise. The team also consisted of high caliber practitioners with varying levels of experience reducing the average bill rate.

Results

The Clinical Data Support System was completed 2 weeks ahead of schedule and $32,000.00 under budget even with new work discovered during the project. Despite the number of source systems and complexity of the data, the system was released with zero defects.

“This was a huge undertaking and there were a lot of challenges. We trusted the 3KC team to deliver, and they did. This was our smoothest release in our history.” Senior Director, Enterprise Analytics, Client.

Tags
Project Management, Business Analysis, Managed Services, Clinical Decision Support System, BioTech, Success.