APCER Pharma Solutions utilizes its global knowledge and local expertise to harmonize the world of safety reporting, medical information, and regulatory affairs for its clients. To intake adverse events (AEs), medical inquiries (MIs), and product complaints (PCs), APCER staffs an Integrated Response Center that supports and reconciles contacts made by phone, fax and email. The same qualified individual handles a case from receipt through closure of the final step for which APCER is responsible in the process.
APCER has a robust, validated technology platform available to manage the processes and data associated with case processing, medical information requests, product complaint handling, paper-based or electronic regulatory submissions, and literature search. It is overseen by safety application specialists and designed for high availability, security, and privacy. Regardless of the geographic location a case is handled, a complete and common set of standard operating procedures (SOPs) is used. Physicians and team leaders are always available for consultation and escalation.
- Global, unified team of healthcare professionals, scientists, and technologists
- 24×7 Integrated Response Center to receive, process and follow-up on AEs, MIs, and PCs
- Complete and common set of SOPs worldwide
- Services built on global technology platform
- Team of Qualified Persons for Pharmacovigilance (QP-PVs) and Deputy QP-PVs available