CTG Drives Efficiencies for Global Pharmaceutical Leader for More Than 30 Years

The Client

Throughout our more than 55-year history, CTG has consistently delivered world-class quality and reliability in IT services and solutions. In 1991, CTG began working with one of the world's leading pharmaceutical manufacturers. Founded over a century ago, the company has grown from a small Midwestern brand to a global pharmaceutical powerhouse, with a company culture focused on research and quality. The provider selected CTG based on our extensive experience in health and life sciences, as well as our reputation for delivering reliable, consistent support across a range of functions, including legacy application support and quality management.

Challenge

One of the first areas of focus for the CTG team was Computer System Validation (CSV). Initially, client needs in this area centered on basic staff augmentation and consulting services. As the regulatory emphasis grew, so did the client's demand for CSV expertise. Additionally, requirements in drug research and development differed from traditional IT needs, and there was often not a ready market of commercial, off-the-shelf systems available to solve the specific, individual requirements of each organization. The client needed comprehensive support across multiple areas including toxicology, clinical trials, and process improvement.

Solution

CTG was selected as the client's IT partner through a competitive RFP process to provide comprehensive desktop support services. CTG provided 24/7 onsite technical support, with a diverse team of experienced technicians (including military veterans) conducting daily rounds to maintain 475 user devices and performing quarterly maintenance on 175 label printers. This proactive approach ensured all equipment remained fully operational, minimizing downtime and improving overall efficiency.

Computer System Validation: CTG provided expertise in the form of validation strategies, coordinators, documentation specialists, and test leads and analysts. Over the past 15 years, CTG's work in this area has matured greatly, successfully progressing to meet the industry's changing regulatory landscape as well as evolving client needs. CTG helped the client establish a Validation and Testing Center of Excellence that provisioned services to many client projects and organizations under a single governance structure. The CTG team created metrics to measure and track quality and performance and created service-level agreements to guide processes. CTG also brought expertise from Europe and provided testing methodology enhancements out of our proprietary STBox (Software Testing Based on Experience) Methodology.

Facilitating Development: To address development challenges, CTG used a hybrid development model, incorporating elements of traditional and Agile development methodologies to produce unique solutions critical for furthering the client's R&D processes. Over the last decade, the CTG team has successfully developed more than 100 distinct solutions designed to aid product development. A typical solution takes approximately 60–90 days to deliver, and the team is generally working on multiple solutions simultaneously. Using this approach, the CTG team has been able to maintain customer focus and effectively prioritize development needs while delivering consistent value, a feat that other vendors have been unable to match. Solutions span the areas of vendor management, inventory control, video lab monitoring, data analysis tools, customer surveys, work order management, and beyond. Over a two-year period, the CTG team drove numerous product research and development efforts for the client, with consulting projects focused on areas such as overall program management, software architecture assessments, integration testing, metrics reporting, and beyond.

Toxicology: In the mid-2000s, CTG's work extended into the client's toxicology area, where the team executed a large-scale data migration and retirement effort that involved retiring approximately 10 VAX-based systems and converting/migrating the data into a long-term platform independent repository. The project integrated data from legacy archives into the Electronic Data Archive system, keeping the data accessible to the scientific community and FDA. Following this success, the client commissioned CTG's support on a second endeavor in the toxicology space: creating a solution for deliverable-based system requirements for data-retaining and non-data-retaining systems. The design included validation package retirement and conversion to Good Research Practices as well as post-retirement reviews. Many of the systems that were retired were lab systems or a data warehouse for research data. These enhancements enabled scientists to streamline documentation writing processes and spend more time in the lab.

Clinical Trials: CTG's strong results in the areas of quality management and solution development led to other engagements across the client's organization. Beginning in the early 2000s and continuing today, CTG extended its services to the area of clinical trials management, where team members spearheaded initiatives related to requirement and design review, quality assurance of site material and web content, development and review of test scenarios, development and review/execution of test cases, development and review of test summary reports, and migration of studies into production. Today, our key deliverables are on-time delivery and no auditable findings due to testing. To achieve this, testing is completed on time so that FPV (first patient visit) is not affected and our testing documentation follows a strict test strategy that builds quality into all stages of the testing process. The Testing team also regularly provides input on how the client can optimize and modernize their quality process, software systems, and tools to help accelerate their digital transformation.

Improving Underlying Processes: While the client's focus remains on research and development and managing a robust pipeline of new drug candidates, focus must also be given to running and maintaining core business functions. CTG has delivered support across many business areas for most of our over 30-year engagement with the client. Specifically, the team assisted Global Marketing Applications and Corporate Affairs (GMACA) in providing web development services, basic desktop support, new applications development, development and support, and ongoing application maintenance efforts. For the manufacturing quality systems team, CTG delivered primary support for several systems. One such project was the transition from a paper workbook manufacturing system to a computer-based manufacturing system for the parenteral team, who had never used testing software before. CTG's Testing team was brought on to help with the installation of Micro Focus Application Lifecycle Management and Quality Center; setup of the project; training the team on policy and use; authoring and executing test scripts; and managing defects. The Validation team was also brought in to work with design specifications; release description documents/test summary reports; business continuity, disaster recovery, and security plans; system and document periodic reviews; and change requests. The Validation team also provided consultation and assisted in the development of all CSV documents, including routing design specifications for approval before the testing process could begin, and test summary documentation when testing was complete. Once the software was released, CTG began maintenance of the system in the four core areas: Diabetes Care, Diversified Health Care, Packaging and Devices, and Dispensing. 

Results

CTG's Data Migration Project (DaMP) received a regional North American award because it provided an innovative, long-term solution for data archival needs across all business units. Additionally, the project met or exceeded all of its business justifications and came in on time and under budget.

Using CTG's development approach, the team has been able to maintain customer focus and effectively prioritize development needs while delivering consistent value, a feat that other vendors have been unable to match. Solutions span the areas of vendor management, inventory control, video lab monitoring, data analysis tools, customer surveys, work order management, and beyond.

To date, CTG has provided our client with expert CSV consulting and solutions, 100 solutions to aid in product development, an award-winning data migration and retirement effort, clinical trials management, and process improvement. Moving forward, CTG continues to provide our client with reliable, value-add IT solutions and services that meet their evolving industry and regulatory needs.