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Project: Siebel CTMS Project
Industry/Company:Healthcare/Life Sciences
Users:10,000+
The Business Story...
This client is the only fully integrated bio and pharmaceutical services provider offering Clinical, Commercial, Consulting and Capital solutions worldwide. With 23,000 employees in 60 countries they have helped develop or commercialize all of the top 30 best-selling drugs. This client is a leading Contract Research Organization (CRO) serving the pharmaceutical, biotechnology and healthcare industries. The client’s Clinical Group provides routine and non-routine research, services and facilities necessary to support all phases of the Clinical Trials Management process.
Purpose
Quality data is at the core of everything they do at this client, and with that data being held in a number of separate systems, the client recognized that they needed to optimize the way they do business to enable a library of Clinical Trial Management data that is high in quality, to ensure trials are conducted to the highest level of excellence, data quality and patient safety. One of the ways in which this was addressed, was the implementation of an innovative, "Best in Class," Clinical Trial Management System, to underpin their ability to manage a single source of integrated trial data, to help drive and support the Biopharma industry as they develop and market new drugs during these increasingly challenging times, and to provide their customers with the best-in-class clinical development methodology.
Project Overview
The new Siebel Clinical Trial Management System (CTMS) as a platform to track and logically structure information will enable the client to better manage day-to-day activities through one source of clinical tracking data across the globe. Siebel CTMS covers functionality across 58 different business process areas, with links to more than 30 other systems within the organization. It was implemented in 3 phases, spanning a period of 12 months – Release 3 went live in October 2010. For Releases 1 and 2, Access to Patients, Feasibility, Site ID and Quality Assurance were the first to experience the new CTMS. Release 3 functionality covered Clinical Tracking, Regulatory, Site Visit Reporting, Site Start Up, Site ID, Investigator Payments, Site Contracts, Project Management, Data End Game, Project Close out, Patient Recruitment, Study Milestones, Queries, Reporting, and enhancements to ATP, Feasibility, and QA from Release 1.
Project Management
Eagle Creek provided an onsite Delivery Director / Senior Project Manager and a Managing Consultant to ensure the project success, with both working as an integral part of the overall client Project Management team.
- Project communication and coordination between Off-site and Off-Shore development, testing activities, client project leads and management, to meet deliverable timelines, quality expectations and customer satisfaction.
- Weekly status reporting to client Project Management.
- Billable and Non-Billable hours tracking, Budget Tracking and reporting.
- Issue Escalation for Eagle Creek and client project issues.
- Project Steering Group/Stakeholder reporting and meetings.
- Adapted Eagle Creek standard SDLC development practices into the client Agile Development process
Services Provided
Eagle Creek, using a combination of Off-Site and Off-Shore Project teams and On-Site leads provided the following services for the project:
- Development of more than 20 Interfaces using – EIM and EAI.
- Customization of screens and views, resulting in the development of more than 30 new complex Screens.
- Specification and development of more than 100 BI Reports.
- Development of more than 100 External Business Components and Integration Objects to facilitate a real-time Data Store for BI Reporting.
- Provided “Best of Breed” development recommendations for success of the project development.
- Developed and executed a complete QA & Integration testing plan.
- Created Functional and Technical Design Documents for all the development work undertaken.
- Eagle Creek Business Analysts collected and refined the initial Business Requirements to meet deliverable expectations, and at the same time brought the client Business SME’s and Business Analysts up to speed with the functionality and capabilities of the Siebel CTMS system.
- Conducted thorough documentation and knowledge transfer training sessions for the client’s global development and support teams.
- Completed solution included the following development activities
- New Business Components – 367
- Changed Business Components – 559
- New Views – 236
- Changed Views – 292
- New Applets – 528
- Changed Applets – 776
- New Lines of Code – 87,000+
Results & Benefits
- Eagle Creek took on more project responsibilities/roles as the project progressed to ensure that the project go-live objectives were met.
- The Eagle Creek team peaked at 130 people, comprising 35 Onsite, 70 US-based Project Center and 25 Offshore Project Center consultants.
- The Releases were delivered on-time and on-budget to client’s expectations, and exceeded those expectations in terms of the quality of the deliverables and the number of defects encountered.
- Project delivery allowed the client to achieve the expected ROI.
- Replaced 10+ existing legacy systems and numerous manual tracking systems.
- Interfaces developed to 37 other internal systems.
- 10,000 Users globally, by end of 2011.
- All Business lines entering and viewing data in a single system
- Access to detailed, site-centric data, from a single location
- Views into feasibility recommendations from a single location, without the need to request updates
- A single source for all site information.
- A globalized approach to Investigator QA review and assignment of QA status
- Track integrated regulatory and ethics submissions in a consistent manner
- Manage SVR, Site Management, and Enrollment in a single system – eliminating double data entry
- Track communication with all sites, investigators, and sponsors
- All clinical trial documents are now tracked in a consistent manner
- Global system for processing Investigator Payments
- Integration with other systems to ensure transparency of data
- System notification and escalation to ensure data is entered in a timely manner
- Consistent System validation rules and compliance reports to help improve quality
Why Eagle Creek?
Eagle Creek can help you cut Siebel implementation costs, reduce risk and positively increase the user experience. Our focused approach assures you'll get consultants with a depth of experience that multiple-solution service companies just can't provide. Our skilled professionals will deliver the highest quality services for the least possible cost — and we'll guarantee it.
Contact: Kevin Burkhart
Sr. VP Health Sciences
Eagle Creek Software Services
704.602.3050
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