Launching a Global Medical Information System for a BioPharma Company that specializes in Rare Diseases
Our client, a New Hampshire based global biotechnology company invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. As a market leader in discovering and developing medicines for life-threatening genetic disease, the company has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
THE BUSINESS NEED
With its marketed drug portfolio and recent FDA product approvals, the BioPharma Company defined a long-term goal to setup and streamline its previously outsourced medical information management business processes by using an advanced software solution for managing all incoming product information requests, fulfilling medical inquiries, handling product complaints, and timely reporting adverse events. Since the advanced medical information management solution was positioned and expected to be used even for those products in the matured pipeline, Our Client wanted to leverage a software solution that can scale-up with advances in technology for offering world-class product information support to its consumers.
CLIENT REQUIREMENTS & CHALLENGES
Our client had performed a rigorous assessment of their current medical information process and observed that there were several technology inefficiencies, communication, and coordination gaps. Following was some of the key challenges:
- Engagement with multiple medical information contact centers and disparate databases, global operations were managed inefficiently as each contact center was following a different workflow for case management.
- The medical information data residing on localized databases could not be combined to provide insights on Our Client’s medicinal product portfolio.
- With multiple manual processes and limited access to medical information data, case management activities took a longer time to complete and there were no provisions to define and track KPI metrics.
- The processes were partner-dependent, and they were using non-integrated content management. There was a lack of integration with business systems.
With the core objective of addressing their medical information business challenges, our client had evaluated and selected SciMax as their technology partner to implement, validate and rollout its proprietary ‘MedInquirer’ solution to digitally transform and optimize their business process.
SciMax built a reinforced team of experts in global regulatory affairs, technology, management, and operations. The project was put on a fast track with very high priority. The team met with the key personnel from the client side and devised a very phased approach for rolling out the MedInquirer solution to the US and Europe regions. Based on the risks identified in the project plan, many tasks were completed concurrently by specialists in each discipline, since there was no room for delays.
Key Project Milestones & Outcomes:
To govern the overall project, the executive team from SciMax and the project steering committee from our client worked together to establish:
- Project Goals & Success Criteria
- Project Scope definition
- Stakeholder identification
- Project Planning & Risk Management – Target schedules & deliverables
- Project Work Breakdown Structure (WBS)
- Project Communication & Reporting Plan
- Quality & Deliverables Acceptance Criteria
- Clear project goals and project scope boundary were finalized to measure the overall project success.
- Using the WBS, the parallel execution of work stream activities by SciMax shortened the project duration.
- Coordinated effort to complete tasks was achieved faster with the identification of ‘Roles & Responsibilities’.
- With proper risk management, Our Client project steering committee was made aware on critical tasks which required more meticulous effort & involvement
To account for global GxP compliance, SciMax adopted the ‘GAMP5 – Risk-based approach’ to implement and validate the ‘MedInquirer’ solution for the client. Using our lean validation methodology and comprehensive test documentation, our team setup 3 system environments on our fully-managed cloud platform.
- With our team owning the validation planning, execution of Installation Qualification (IQ) and Operational Qualification activities, we significantly reduced the overall validation effort, project time and involvement of resources from the client side.
- The executed validation documentation was very comprehensive that our client had leveraged the approved test scripts package for developing their UAT scripts.
As part of the MIQ Cloud onboarding process, SciMax’s MI Solution Delivery team had conducted extensive hands-on workshops to identify and finalize the MedInquirer baseline configurations that streamlined the core MedInfo operations across the US, Europe and Australia regions for the client.
- Key configurations such as case workflow definitions, content management controls, user security management, case correspondence & case transmission email templates, case validation rules etc. were dry-run and finalized by the client’s Global Medical Information (GMI) Division.
- The business team was able to leverage the flexible application configurations available in MIQ to streamline medical information business processes for both the US and Europe regions.
- MedInquirer’s built-in Inbox established unified case communications directly within the application. Our client did not have to login to Outlook or any other email system to initiate email communication or manually search and upload case source attachments.
SciMax had provided an extensive hands-on training to end users on MedInquirer’s feature functionalities, configurations, and administration tasks. We used 'Train-the-Trainer' model to build in-house MIQ knowledge pool for the client.
To simplify the UAT execution, SciMax provided the detailed standard test scripts using which the client's quality and business team developed the final process specific UAT scripts. We also provided support to users during the time of UAT execution.
- With our in-depth system training, the client developed process-oriented application training modules to scale-up competency amongst its global users across US, Europe and Australia.
- The client’s business team had leveraged SciMax’s validation package to prepare and complete User Acceptance Testing (UAT) to validate their real-time business process and application configurations which reduced the overall project time.
As part of solution rollout, SciMax had developed and scheduled several business reports and KPI dashboards within MedInquirer as per our client’s business requirement.
- The built-in reports available within MedInquirer helped our client’s GMI group to schedule case reports & metrics to be delivered directly to the business team’s email accounts.
SciMax’s Service Desk team had offered extensive cloud and MedInquirer application support to enable smoother transition for the client business users.
A formal Service Desk communication plan was prepared and shared with the client’s business team to leverage SciMax’s MedInquirer support on a 24x7x365 basis for submitting user requests, reporting application incidents, and preparing for configuration change management.
The readily available standby support from SciMax’s MedInquirer Service Desk enabled the client’s business team to troubleshoot and resolve un-anticipated issues after ‘Go-LIVE’.
With the successful implementation of MedInquirer by SciMax, our Client achieved the following business objectives:
- Successfully launched a unified and configurable medical information system that is used internally by their team and their global contact center partners.
- Enhanced their capability to generate actionable insights with daily, weekly, monthly operational metrics reports that helps to identify trends and drive process improvement.
- Empowered their business teams to leverage an efficient, and user-friendly system to digitally streamline Medical Information workflow processes across regions and contact centers.
- Established a centralized location for the development, management, and distribution of medical information content for inquiry response fulfillment.
- Leveraged a powerful MI platform that will further transform the MI function through continuous innovation.