Company upgrading to ARISg 7x to meet E2B R3 requirements.
Co-led Program Management Office with direct responsibilities of managing the integrated project plan and project issues/risks/actions. Led Core Applications work stream to manage agXchange and ARISg upgrades, develop E2B R3 compliant business processes, perform impact analysis for configurations and customizations, manage development deliverables from internal client and Aris Global teams, led business testing and business deployment activities.
Company implementing ARISg needs support to manage business activities including distribution rules (approximately 750 rules for 80+ contacts), CPD and Protocol Library setup.
Managed business workstream including training, developed strategy and design to build ~750 rules (conditions) for ~80 recipients (authorities + license partners), authored requirements, managed and performed User Acceptance Testing to confirm development.
Company acquisition required data migration of 50,000+ cases and 40,000 case receipts in to the acquiring company’s global safety database.
Prudentia defined mappings, developed source to target migration code, authored validation documents and executed the migration and test scripts. Prudentia also led the decommissioning of the legacy safety database post-migration.
Company with multiple vendors using different applications to capture AE data at source. Each vendor application had different set of fields and attributes to capture AE data.
Prudentia supported definition and development of standard AE data capture fields and values supported by standard E2B as well as.
E2B+ tags. Prudentia developed the E2B+ profiles in Argus for importing cases from each vendor. Prudentia defined the business process to auto-import initials and manually process follow-ups in Argus.
Company needs to manage growing CT case volume without significantly increasing operational costs.
Developed a plan and expertise to implement an efficient solution utilizing E2B transfer from clinical EDC system into ARISg. Although E2B is standard for exchanging data between Safety Databases, challenges exist with EDC integration. Prudentia supported the client with addressing challenges such as event level vs. case level, E2B+, MedDRA coding, follow-up processing.
Company needs support with increasing demands from user community around Reporting and Configuration. while in-house support team works on recent inspection CAPAs and ARISg upgrade.
Quickly provided cost-efficient resourcing with ARISg experience to manage configurations, master data maintenance and reporting requirements.
Company running Argus 4.2x had limited ability to allow business users to get timely information from SDB without data management team.
Designed a BI architecture to enable ready access to safety information.
Solution is being incorporated into SDB upgrade with self-service model for end-users with fewer DM FTEs developingad hoc queries
Company using ARISg hosted by CRO needed access to data. Reports were limited to QBEs and SQL Plus Excel spreadsheets (BO Universe and custom reports not available).
Prudentia offered a solution to query ARISg and launch custom reports. PV TREND™ developed within 6 months with 5 out of the box reports and capability for end users to “paint” their own reports.
PV TREND™ is an end-user general purpose PV data analysis tool providing users with dashboard of trends
Company needs to separate into two companies (innovation and generic). PV systems and processes are part of the separation.
Developed and implemented a plan to clone the ARISg suite of applications from one company to the other. Clone includes data separation, configuration modifications, and knowledge transfer to new organization.
Company needed to reassess current Safety BPO partner & determine other options for future growth (territories, products, trials) & viability of partner.
evaluated partner’s services, issued RFP, selected new vendor, and led migration to new vendor.
A top-10 global pharma company was using multiple coding platforms across Clinical and Safety for query management, drug groupings, and clinical data coding. This created unnecessary complexity and limited operational efficiency.
The organization needed a more connected approach that could bring these activities together in one comprehensive solution while supporting enterprise-scale use and aligning with existing coding practices.
Prudentia deployed MedCodr, along with MFI, to provide a centralized environment for clinical coding and medical dictionary browsing. The implementation included integration with the client's EDC solutions, SSO, migration of studies, custom queries, and drug groupings from legacy systems, and targeted functional enhancements to align the platform with the client's established coding practices.
The solution was delivered as a fully validated out-of-the-box deployment, supported by training materials, end-user training, hypercare, and ongoing release management, validation, enhancements, and study and dictionary management support. This gave the client a practical path from fragmented operations to a more streamlined, scalable coding environment.
The client moved from a fragmented multi-platform model to a centralized coding environment designed to support greater consistency and operational efficiency across clinical and safety.
MedCodr was implemented as a one-stop-shop comprehensive solution supporting more than 200 users, helping the organization simplify coding-related activities across teams and establish a scalable foundation for enterprise deployment and ongoing adoption within a global operating environment.
A centralized coding model can reduce operational friction when clinical and safety teams are working across disconnected systems. In this case, Prudentia helped the client consolidate coding, dictionary browsing, query-related activities, and legacy assets into one validated solution that was built to support scale, usability, and longterm operational continuity.
A top-20 global biopharma company needed to replace a coding solution that was no longer supported by its vendor. At the same time, dictionary maintenance and upgrades had become too difficult and costly to manage, and the company was also experiencing integration deficiencies with its existing EDC systems.
The business needed a modern, validated replacement that could reduce operational burden without creating unnecessary disruption.
Prudentia deployed MedCodr and MFI in a hosted dedicated environment and integrated the solution with the client's EDC systems, including Veeva Vault and Inform. The platform was delivered as a fully validated out-of-the-box solution, while still allowing the client to complete additional validation activities, including UAT, in line with its own CSV practices.
The implementation also included end-user training, hypercare, and ongoing release management together with study and dictionary management support. This gave the client a validated and integration ready platform that could replace the unsupported legacy system while fitting into the company's regulatory and operational framework.
The client moved to a dedicated hosted coding environment designed to make dictionary maintenance more manageable and improve integration with its broader clinical data ecosystem.
The MedCodr deployment supported more than 80 users and established a more sustainable foundation for ongoing coding operations, release management, and study and dictionary support, while addressing the client’s three core pain points: unsupported legacy technology, upgrade burden, and integration gaps.
For biopharma teams, replacing an unsupported coding platform is not just a technology decision; it is an operational and compliance decision as well. In this case, Prudentia helped the client modernize its coding environment with a validated solution that reduced maintenance burden, improved interoperability, and supported longterm use in a regulated setting.
A top-30 global pharma company needed to replace a coding solution that was no longer supported by the vendor. The company was also dealing with difficult and costly dictionary maintenance, as well as integration deficiencies with its existing EDC solution.
The priority was to find a more supportable and cost-effective alternative that could improve connectivity across systems while working within the company's validation framework.
Prudentia deployed MedCodr and MFI in a hosted dedicated Dev/Val/Prod environment for clinical coding and medical dictionary browsing. The implementation included integration with the client's EDC systems and SSO, creating a more connected and user-friendly operating environment. The solution was delivered as a fully validated out-of-the-box deployment, and Prudentia worked closely with the client's validation team to define deliverables that could be repurposed within the client's CSV process.
The client then completed additional validation activities and developed further documentation as needed. End-user training, postgo- live hypercare, and ongoing study and dictionary management support were also included.
The client gained a dedicated hosted coding environment designed to address both technical and operational pain points. MedCodr provided a modern replacement for the unsupported legacy system while supporting stronger integration, a more manageable validation approach, and ongoing study and dictionary support.
The implementation supported more than 80 users and created a more practical long-term foundation for coding operations, with a solution designed around improved integration and a more cost-effective operating model.
When sponsors evaluate medical coding solutions, the real decision often extends beyond functionality alone. In this case, Prudentia helped the client adopt a validated, hosted, integration-ready solution that reduced the burden of maintaining an unsupported platform and provided a more practical path forward for regulated operations.