- Problem – Company running Argus 4.2x had limited ability to allow business users to get timely information from SDB w/o data management team.
- Solution – Designed a BI architecture to enable ready access to safety information.
- Results – solution is being incorporated into SDB upgrade with self- service model for end- users with fewer DM FTEs developing adhoc queries.
- Problem – Company needed to reassess current Safety BPO partner & determine other options for future growth (territories, products, trials) & viability of partner.
- Solution – evaluated partner’s services, issued RFP, selected new vendor, and led migration to new vendor.
- Results – Company transition to new vendor in 6 weeks (including data migration) Company’s expedited case compliance to FDA and license partners remained at 100% Cost of processing cases reduced 20%+ Company is poised for E2B transfer with partners and with EDC for trials
- Problem – Company needs to separate into two companies (innovation and generic). PV systems and processes are part of the separation
- Solution – Developed and implemented a clone the ARISg suite of applications from one company to the other. Clone includes data separation, configuration modifications, and knowledge transfer to new organization
- Results – Knowledge transfer across 10 systems during 4 month period confirmed Successful go-live of separate Safety database for both companies No critical case processing or technical issues experienced at go-live and during ‘hypercare’ period Transition to operational support
- Problem – Company needs to manage growing CT case volume without significantly increasing operational costs
- Solution – 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
- Results – Standardized set of eCRFs designed
eCRF to E2B mapping developed
EDI Gateway vendor selection
ARISg configuration completed
Business Process for E2B processing implemented
Three studies live to date
- Problem – 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
- Solution – Quickly provided cost-efficient resourcing with ARISg experience to manage configurations, master data maintenance and reporting requirements
- Results – 5 FTEs supporting 21×5
Distribution Rules configuration and testing
Reports Development and testing
User Account Management
Protocol Library Maintenance
Company Product Dictionary Maintenance
Client portfolio continues to expand