Global CRO streamlines project management, cuts clinical trials lead time
The client, one of the top five global CROs, provides clinical development, laboratory and research services to leading pharmaceutical, biotechnology, and healthcare organizations across the world.
The client engages with clinical research sponsors to execute clinical development and laboratory research projects. A key business challenge faced was the absence of standard project management processes and an enterprise view of project data.
To retain its leadership position, the client wished to improve its project management processes. It also wanted to leverage existing IT infrastructure to the extent possible. The following specific objectives were identified:
- Reducing study setup lead time
- Reducing study execution lead time through Web-based collaboration on task tracking and status reporting
- Standardizing tasks, milestones, and metrics to enable enterprise-level reporting
- Improving maintainability and portability of project management systems
The client selected Infosys due to its extensive knowledge and experience in FDA’s Computer System Validation (CSV) principles ─ a key success factor for the project. Infosys deployed a cross-functional team to conduct an in-depth analysis of the client’s requirements.
The solution leveraged Microsoft Project Server, which the client was already using. Templates and project guide were mapped to reduce study set-up lead time. Analysis Services, Office Web Components, and SharePoint Portal were leveraged to facilitate enterprise collaboration and reporting, thus reducing study execution time. As a Microsoft partner, Infosys was also able to access Microsoft’s expertise for customization and extension of the off-the-shelf Project Server.
Infosys evolved standards across geographies and business groups. Constraints around maintainability and portability were overcome by defining and enforcing standards for customizations and extensions.
The entire project was delivered by leveraging the Infosys Global Delivery Model. Our CMMi expertise helped create customized CSV-compliant deliverables that met the FDA’s stringent compliance requirements.
The project was executed in two phases:
Development of custom project guide to help project managers from the client’s clinical development group create and track their project schedules.
- Development of custom project guides for project managers from laboratory services, pharmaceutical services, and IT.
- Project server extensions to support other project management areas such as status reporting, risk management, metrics, and resource management.
Software development approach
Infosys adopted a four-stage waterfall model for software development. The software development lifecycle (SDLC) was customized to meet the FDA CSV requirements.
A cross-functional team, comprising clinical, laboratory, scientific and IT personnel from US and Europe was set up for specifying requirements. After generating user interface (UI) mockups for visual appreciation, 15 requirements specification documents were created in an IEEE-based template. They were formally reviewed and signed-off by all the team members.
Detailed designing followed for each module and components such as ASP scripts, SQL Server-stored procedures, and Cube specifications for analytics. Design elements were matched with numbered functional requirements to facilitate traceability and validation.
Infosys helped finalize coding standards keeping in mind specific objectives related to:
- Identification of standard product code and customizations / extensions
- Maintainability of customizations
- Traceability of code to requirements, design, and test cases
- Traceability of unit, integration, and system test plans to requirements and design elements
Development and testing
The development team published a high-level design document with module decomposition and deployment structure, along with a data dictionary for customizations / extensions. It coded and unit-tested the modules and recorded unit test results in physical form. This, followed by integration and system testing, comprised the operational qualification of the system, supported by physical records of testing and screen shots.
Infosys specialist communication design group created user manuals based on requirement specifications and beta versions of the system. Performance Qualification Protocol (PQ / User Acceptance Tests) helped appropriate sign-offs. The installation scripts, installation qualification, and systems manual enabled installation and operation of the extended system.
- Rigorous software engineering processes of Infosys strengthened the client’s internal processes around defect prevention, tracking, review and resolution, thereby increasing its own capability to develop robust software.
- The client obtained tailor-made methodologies and templates for use in downstream projects.
- The rapid and cost-effective customization, and extension of Microsoft’s Project Server platform gave the client a validated system that delivered specific business benefits such as:
- Improving efficiency in project plan creation, task tracking and status reporting
- Enabling analysis of metrics, risks, milestones, and resources at project / program / enterprise level
- Improving portability of extensions
- Leveraging advanced Microsoft tools through a user-friendly system
- Enhancing maintainability and usability of project management systems
- Improving collaboration between project team members
- Maintaining a repository of current and past trials with advanced search features for business development