Subject
Our client is a prominent global Contract Research Organization (CRO) known for its expertise in overseeing clinical trials across diverse therapeutic areas. Renowned for its commitment to ensuring timely project delivery and consistent patient enrollment, this client invests significantly in accurate feasibility assessments, involving medical professionals to predict study timelines effectively. Supported by a committed team of over 2,700 professionals, the client works passionately across 60+ countries.
The client grappled with a decentralized training management system, storing training-related data in disparate ways. Their primary formal requirement was to centralize this data for better management, seeking a unified platform to efficiently oversee and manage it.
They aimed to meticulously track their projects and exert significant influence while simplifying project management. Projects were intricately linked to specific roles within their organization, dictating training needs for participants. This demanded a stringent, validated environment where individuals had to undergo training. Verification of training completion was crucial, especially in scenarios such as audits necessitating proof of participants’ completed training.
Therefore, the client desired the ability to track who belonged to which process/project and what specific requirements existed within each. They had three main objectives:
- Centralization: They wanted all this GxP information consolidated into one repository, eliminating scattered archives.
- Accessibility: Easy access to this centralized GxP information was crucial for seamless management.
- Simplified management: The client sought an intuitive and organic system to manage these GxP aspects efficiently. For instance, whenever a new project commenced, they wanted a simpler way to manage individuals and have documented proof of all required training completed by process participants.
The challenge lay in creating a streamlined system that catered to these multifaceted needs, integrating training requirements with project roles, and ensuring accessibility and simplicity in managing this amalgamated data effectively.
The customer chose eConsulting for the implementation of the Cornerstone OnDemand LMS and Core modules because of our expertise and extensive experience in validation processes. Being a prominent competency center for validated CSOD, our team’s proven track record and specialized skills aligned perfectly with the client’s needs.
Scope of work
The project comprised 4 phases:
Discovery:
We sent the client various questionnaires with diverse questions allowing us to subtly determine key decisions that would later impact the system. At this stage, the client was to provide us with scenarios and process descriptions. However, due to the lack of detailed descriptions from the client, we offered an additional service – Business Process Alignment (BPA). During the BPA, we assisted the client in creating processes to maximize the benefits derived from it.
Simultaneously, we conducted a Validation Workshop, a crucial session delineating Cornerstone’s validated environment methodology and maintenance approach.
Configuration:
Our next step was to design the configuration to meet the customer needs.
During this phase, we worked on separate technical projects for the client: Single Sign-On (SSO) and MS Teams Integration. MS Teams Integration was especially helpful for live training sessions during the Covid era. This made managing sessions easier by allowing sign-ups, real-time monitoring of attendance and duration, and simplifying post-training data handling.
Proof of Concept:
In the Proof of Concept stage, we demonstrated the system’s functionality using mockups and refined all aspects. The client was highly satisfied with the POC, providing extremely positive feedback without any comments.
Testing:
We prepared the Configuration Workbook and carefully planned and executed IQ and OQ tests, covering both individual functions and integrations. We then created and reviewed reports.
Before User Acceptance Testing (UAT), we conducted Admin Training tailored to the client’s needs and system processes. We defined the training scope for various user groups based on our knowledge of the client and their requirements.
Due to the lengthy nature of the entire process, Cornerstone released two new releases in the interim. Given the validated process, the entire Release Management Process, including validation activities, testing, thorough documentation, and assessing functionality in the client’s environment, was involved. Consequently, we needed to cover and integrate both these new releases into the documentation.
Result
The implementation lasted for 12 months. It had to be adjusted according to the pace and capabilities desired by the client. In the project, a team of 9 members actively participated, with an additional 3 individuals specifically dedicated to writing test scripts on our side.
The continued collaboration stands as a clear testament to the client’s high level of satisfaction and contentment with our services. The client highly appreciated our experience within a parallel business domain. This enabled us to guide and support them throughout the process, offering invaluable insights to enhance their operations.
Our GxP implementation significantly bolstered and simplified the client’s oversight of ensuring completion of all required trainings for specific roles. Through tailored adjustments and streamlined processes within the system, our solution enabled effortless verification of training completion and facilitated the addition of new courses when needed. Additionally, by introducing a range of roles that catered to the client’s business needs, we effectively distributed and managed work responsibilities, avoiding overburdening any single individual. Cornerstone also offered the client a means to manage smaller teams with ease. This flexibility allowed them to create, oversee, and verify numerous smaller teams—an essential feature highly valued by our client.
Explore how we can tailor solutions for your unique business needs and streamline your operations effectively: https://shop.econsulting.co/validation-services
