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.