Clinical Trial Management Systems (CTMS)

Clinical Trial Management Systems (CTMS) are vital to today’s biotechnology, pharmaceutical, and clinical research institutions. The CTMS team of developers at USDM Life Sciences each have over 15 years of experience in all phases of Oracle Siebel implementation and customization. USDM provides innovative solutions which give businesses the tools needed to intelligently plan, conduct, and report on trials and trial data. With a perspective born from experience in solving common issues, as well as a fearless dedication to answer unique challenges, USDM’s CTMS team has never met a problem that went unsolved. Whether you are setting up a new Clinical system, need to upgrade or extend an existing instance, on-premise or in the cloud, USDM offers a wide array of consulting services to help your organization get the most out of your CTMS investment.


USDM Life Sciences’ Oracle certified consultants provide a complete array of services for all stages of life of a Clinical Trial Management System. Leveraging your existing IT assets or sizing a new effort, we have the expertise and competence to communicate effectively to both the business and IT. What sets us apart is the combined focus of our team to provide superior technical guidance along with a careful consideration for the impact of change and maximized long term value. USDM is also able to rely on its core strengths in compliance & validation and project management to offer a one-stop CTMS shop.

Our services include:

• Installation/Implementation
• Initial system build
• Installation of additional components such as BI Publisher
• Enabling/creating server components such as Object Managers
• Installation of additional application/web servers (Windows, Unix, Linux)
• Troubleshooting existing issues
• Customization and application extension
• Enhancement of Vanilla Modules to suit business needs. (document tracking, trip reports, subject management)
• Custom BI Publisher report creation
• Out of box BI Publisher report changes
• Integration with other systems
• Upgrade services
• Installation of Oracle Siebel maintenance releases
• Configuration of maintenance release ACR packs
• Training
• Siebel administrator training
• Siebel configuration and development training

USDM Life Sciences will soon simplify and accelerate the implementation of CTMS by offering a comprehensive Validation Accelerator Pack (VAP). The CTMS team engages business process owners to determine core business needs, then builds prototypes of customizations and suggested workflow. USDM implements the system best suited to the business needs of the client. Our experience with implementation and validation will help speed this process, and deliver a CTMS system ready to handle the most challenging aspects of trial management.

At USDM Life Sciences, the CTMS team has extensive experience with the “Go-Live” of applications and can prepare a client for the challenges that a new release brings. USDM offers instructor led training for system administrators to ensure the system remains available and functional as it grows.

Contact USDM Life Sciences today to learn how our team of experts can help you implement and improve, integrate, and validate your Clinical Trial Management System.



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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