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.

We work together

We have been extremely happy, and we haven't been an easy client. We really appreciate APCER and their patience. Our startup time was practically overnight, and they are to be commended for their project management, capability and presence to stick it out with us. APCER’s expertise, pricing, and team are a nice fit, and they are doing great work. Their size allows us to interact and we don’t get lost in the shuffle. We are completely satisfied.

- VP, Development Operations, US-based biotechnology company

We selected APCER because they were an all-encompassing services provider in that they were able to help us with pharmacovigilance, both in the U.S. and in Europe, as well as Medical Information. They had QPPVs on staff and did not have to subcontract to fill that requirement. The most important attributes we look for are commitments to compliance, quality, and client relations, and we are completely satisfied with APCER in these areas. We have a wonderful relationship with them.

- Director, Pharmacovigilance, Biopharmaceutical company

When we entered the U.S. market with our product portfolio, we wanted one company to handle our US and European sectors. APCER had the global capabilities we were looking for, and they have proven to be efficient and accessible. We are completely satisfied.

- Head, Regulatory Affairs, global generics manufacturer

Together, in our house or yours

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.

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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.

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