APCER provides clinically trained safety specialists and supervising physicians to manage the SAE reporting and query management processes that identify SUSARS and enable on-time reporting to regulators, investigators and IRBs.
APCER’s client-focused teams receive and triage serious and non-serious AE cases, performing detailed case entry and follow-up, narrative writing, quality reviews and medical review, to enable on-time reporting around the globe.
APCER searches the literature for reports of adverse events for all types of products, using standard terms, triage analysis, and relevant processing for expedited or periodic reporting
APCER ensures that periodic reports, safety summary updates, and risk assessment document are created in the proper format with the appropriate clinical content and are submitted to the relevant regulatory authorities within compliant timelines.
APCER performs ongoing signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified and potential signals.
APCER provides strategic advice and analysis; develops US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMPs) for Europe