Together for
Technology
APCER provides complete, fully validated systems for case management, report generation, signal detection, electronic submissions, and regulatory tracking on a hosted basis, giving you a cost-effective alternative to installing and maintaining these systems in-house.
APCER also can integrate seamlessly with your systems to process adverse event cases, prepare and submit aggregate reports, or detect safety signals. We access our clients’ safety databases and other document sharing facilities through secure remote access, SharePoint, and secure FTP services. All information transfer is compliant with EU, US, and all relevant data privacy standards.
Safety Systems
APCER provides a completely managed solution in a multi-tenant environment with a separate database instance for each client.
Medical Information Systems
APCER hosts and uses agInguirer and IRMS to manage Medical Information workflow and documentation.
Signal Detection Software
APCER’s safety system includes a module for signal detection, which is used to support our signaling workflow.
Electronic Submissions
APCER has extensive expertise in electronic submission of expedited reports wherever these are accepted and can work with all types of gateways for undertaking electronic reporting.
Document Management
APCER maintains a production and document management system for compiling, reviewing and publishing regulatory submissions.
Data Migration
All migrations or routine data transfers are managed in a validated environment with full documentation from planning through user acceptance and go-live.
Together, to minimize risks
APCER’s global pharmacovigilance and regulatory platform is installed and operated within its own data center in the United Kingdom under the direction of the Managing Director. All technology systems are validated in accordance with 21 CFR Part 11 and GAMP-5.
APCER has the experienced staff to execute data migration and other database-related activities. All migrations or routine data transfers are managed in a validated environment with full documentation from planning through user acceptance and go-live. These activities ensure compliance and integration of safety data collected across the product lifecycle, from clinical trials to post marketing, and result in the ability to produce aggregate reports with signal detection in the proper format and content for periodic submission to regulatory authorities and other parties. APCER has a formal disaster recovery plan to ensure business continuity.
