Aris Lifesphere LSSRM Implementation - Enabling role played by Ultragenic between the Client and SaaS Vendor
The Challenge
A global healthcare company decided to implement the LSSRM (Life Sciences Signal and Risk Management) tool from Aris Global to enhance their signal detection and management processes. Despite LSSRM’s potential, its nascent state posed several challenges, particularly in data access and custom report generation, which were critical to the client’s business needs. This necessitated the involvement of Ultragenic, leveraging its PV domain expertise and in-depth knowledge of the LSSRM tool, to effectively liaise between the client and the SaaS provider, ensuring the client’s requirements were fully understood and met.
Key Deliverables
- Requirement Analysis: Evaluate current processes, identify specific client needs, and align them with LSSRM capabilities.
- System Configuration: Develop, configure, and validate the LSSRM system, including User Defined Runs and automatic alerts.
- Operational Support and Customization: Define client operational procedures, develop custom reports using LSRA, and draft SOPs for system usage and configuration changes.
- Data Migration: Map, migrate, and validate legacy signals to ensure data accuracy and integrity.
- Training and Artifacts Review: Plan and conduct tailored training sessions, develop training materials, and review artifacts to ensure they meet client needs.
The Ultragenic Approach (Solution)
The Ultragenic team played a critical enabling role between the client and Aris Global (AG), ensuring a seamless implementation of the LSSRM tool.
- Requirement Elicitation: Our team conducted thorough evaluation of the client’s existing signaling processes and systems. We facilitated workshops and interviews to comprehend specific needs and established a detailed workflow that aligned with LSSRM’s capabilities.
- Configuration Development: We developed configurations for automatic alerts, notifications, rules, validation checks, and UDRs. This was aimed at optimizing the LSSRM tool to meet the client’s operational needs.
- Solution Design and Process Definition: We supported the definition of the client’s operational procedures and devised methods for unique functionalities. This included developing custom reports using LSRA for signal detection, which were not directly available from LSSRM.
- SOP Development: Our team drafted comprehensive SOPs to guide the usage of LSSRM and other operational processes, including submission requests for configuration changes.
- Data Migration: We meticulously mapped the data migration process, migrated legacy signals, and validated the migrated data to ensure integrity and accuracy.
- User Requirement Validation: Informal testing of the system was conducted to ensure functionality. We authored Performance Qualifications (PQs) based on documented requirements and business use cases.
- Artifacts Review: We reviewed various artifacts prepared by the ArisG team to ensure alignment with the client’s needs and expectations. We also reviewed the content of eLearning modules and process maps.
- Trainings: Our team planned and conducted tailored training sessions based on the client’s signal detection and management processes, ensuring all stakeholders get well-versed with the new system.
Key Takeaways
- Clear Communication and Liaison: Effective communication and liaison between the client, our team, and Aris Global were crucial. Understanding and translating client requirements into actionable configurations ensured alignment and minimized misunderstandings.
- Customization and Flexibility: The ability to develop custom reports and configurations that catered to specific client needs highlighted the importance of flexibility in software implementation projects by addressing critical gaps
- Thorough Testing and Validation: Rigorous testing and validation processes ensured the system’s functionality and data integrity, leading to a smoother transition and implementation.
- Comprehensive Training and Support: Tailored training sessions and comprehensive support materials facilitated a better understanding and efficient use of the LSSRM tool, ensuring a higher adoption rate among users.
- Continuous Improvement: The iterative process of feedback, review, and enhancement demonstrated the need for continuous improvement in complex system implementations.
Through our role as a Lifesphere Implementation Partner, the Ultragenic team not only facilitated the successful implementation of the LSSRM tool but also ensured that the client’s specific requirements were met, thereby enhancing their signal detection and management processes.
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