Technology

APCER offers a variety of hosted environments for safety, medical, and regulatory operations at a fraction of the cost of in-house systems.

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.

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.

• Safety Systems
• Medical Information Systems
• Signal Detection Software
• Electronic Submissions
• Document Management
• Data Migration

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.