Ultragenic implemented LifeSphere Safety System (including LifeSphere Multi-Vigilance (LSMV) and LifeSphere Reporting and Analytics (LSRA)) for one of the world’s leading healthcare companies branching out its Consumer Health Care products and looking for a strategic partner for establishing an independent PV system.
The Challenge
The challenge involved ensuring an in-depth analysis of the requirements to pre-empt the obstacles in the organization’s PV implementation journey and to provide domain expertise to mitigate the issues before the risks were realized, all the while maintaining a steady pace to oversee and manage system implementation.
The Ultragenic Team served as a conduit for exchanging the systems and process information between the parent pharmaceutical company and the new Consumer Health Care division and overseeing the operational tasks for implementation of the new LifeSphere PV database with the technology partners (Aris Global) and end user groups. Additionally, Ultragenic team’s expertise and domain knowledge was utilized in assisting with large scale case data migrations, building custom reports and distribution rules to facilitate correct submissions, and providing solutions for compliance monitoring, submissions management and defect tracking and management.
Key Deliverables
• Serving as an extension of the new CHC division to elicit requirements and provide specifications to the technology partners (Aris Global, IQVIA, Cognizant) to help them build and deliver the solution on time.
• Extend the system implementor role to double up as a business and change management facilitator to assist track and manage activities contributing towards business readiness for the organization. The activities belonged to a plethora of workstreams including, but not limited to the following:
Case Management, Literature, Compliance Management, Japan Workflow, Periodic Reporting, PSMF, Additional PV Systems, Vendor Onboarding, Resourcing, Submissions management, Change Control Management, GxP & SDLC Documentation, Shared INNs, Transition Management, Training, Therapeutic Areas, Business Continuity Planning, Communication, Activities for Affiliates and Post Go-Live activities.
• Align the system understanding with geographically distributed end users, stakeholders, business, and license partners and to ensure that the end user requirements are correctly translated into system specifications submitted for implementation.
• Collaborate with business user groups, stakeholders and Country Safety Heads to draft, review and manage over 80 SOPs and training documents.
• Extend and scale up the Ultragenic team in response to the dynamic nature of the project implementation and ensuring that the best talent with necessary experience on the LSMV, LSRA and Cognos elements is deployed on demand.
• Out of the box solutions for Data Migration, Distribution Rules, CPD, Custom Reports and User access mechanisms and setup were put in place in a rapid fashion to ensure that there was no impact to regulatory compliance.
• Managing additional iterations, scope creep and quality issues emanating from dynamic requirements coming from partners, Country Safety Heads or vendor groups.
• Managing complexity of the delivery model with multiple stakeholders with specific communication and coordination needs and their need for certain complex data elements and reports.
• Coordinating with reporting agencies and unforeseen irregularities observed due to external factors in receiving the response back in the required time frame and to extend the team for additional effort to bridge unwarranted delays.
• Performing Fit-Gap for 50+ Reports without prior understanding of Source or Target Reports
The Ultragenic Approach (Solution)
• Ultragenic Team was augmented to include highly trained members and Subject Matter Experts (SMEs) proficient in the Lifesphere Suite, Planning, Project Management and Requirements elicitation to counter the technology issues, business management readiness and planning and governance challenges.
• A dedicated knowledge cell was established to sieve through the available recorded sessions and to impart internal trainings via interactions, group discussions and POCs for knowledge transition and understanding of the system.
• Executed additional rounds of validation cycles for a thorough Data Migration to discover errors early and allow ample time for resolution.
• Defined a fresh framework for Distribution Rules leveraging the knowledge from Health Authority and regulatory manuals rather than relying on reverse engineering from the obsolete system. This ensured that the errors in the older system weren’t carried into the new framework while maintaining the necessary and sufficient conditions for regulatory compliance. This significantly reduced the turnaround time for delivery and effort required for defect fixing and regression testing.
• Proposed and successfully conducted the Conference Room Pilot (CRP) workshops for requirements verification with the client and Day In The Life (DITL) workshop with the end users to ensure that the requirements were correctly implemented and the necessary user scenarios were adequately covered by the system.
• Devised solutions and methods for deciphering LSRA data model and developed mappings for accelerated custom report development.
Key Takeaways
• Extensive knowledge gained on the Lifesphere Suite, equipping the organization as a formidable contender for similar projects
• Developed Business Readiness support as a new offering with established methodology
• Team members collaborated closely with case processors facilitating a profound understanding of the nuances and finer details of the business domain.
• Knowledge bank updated with fresh training material achieved via internal LSMV trainings conducted during the project.
• Successful alignment with business expectations has resulted in the potential for increased future engagements with the client. The team is currently gearing up towards LSSRM implementation for the same client.
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