Prudentia provides team experienced in PV systems and technical knowledge to support day to day activities for infrastructure and application related issues reported by end users of drug safety systems. The team is available in various time zones depending on global user base.
Prudentia provides experienced cost-effective configuration administration of drug safety systems including master data libraries such as:
1. Product Library
2. Protocol Library
3. User Maintenance
4. MedDRA Dictionary Management
Prudentia’s team provides configuration services 21×5 to support multiple time zones based on user requirements
Prudentia’s business and validation analysts support large and medium sized companies with maintaining the submission rules library in the safety database. Services include managing user requirements document in collaboration with local safety affiliates, managing scheduled reviews with regulatory responsibles, supporting the development activities, configuring the submission rules in the application and testing the rules to ensure compliance with regulatory requirement.
Prudentia supports inbound and outbound E2B setup required for exchanging XML files to regulatory authorities, business partners and EDC systems. Services include development of E2B and E2B+ profiles, application configuration, gateway connectivity testing, and business scenario testing with partners.
Prudentia supports business end users to resolve data query needs by either front end reports or backend database extracts. Services include configuration of queries (private and public) to get desired data set, development of SQL queries for backend database extracts, development of custom reports using Business Intelligence tools such as Crystal Reports, Business Objects, Cognos or OBIEE, and validation of reports to confirm data accuracy and consistency. Prudentia’s analyst also support end users with identifying and defining custom report requirements.
Prudentia supports companies without E2B R3 compliant safety databases with conversion services which include business analysts performing daily EudraVigilance searches for company’s ICSRs to be downloaded (e.g., MLM and NCA cases), converting the downloaded E2B R3 ICSRs into a compliant E2B R2 file using Prudentia’s E2B BRIDGE conversion application, maintaining a daily tracking sheet of ICSRs downloaded and converted, and optionally importing the E2B R2 file into the company’s safety database.