Together for
Pharmacovigilance
The focus of PV regulations has shifted from reacting to events to identifying and planning for potential risks. APCER Life Sciences helps companies document the safety profile early in a drug’s lifecycle, beginning with the safety section of the clinical trial protocol and the safety management plan.
When it’s time for market authorization, we can provide a QPPV and help you create the Pharmacovigilance System Master File and risk management plan – and maintain these important documents throughout the life of the product.
APCER has extensive experience in signal detection and benefit-risk analysis. Our process for harmonizing periodic report submissions across Europe has been reviewed positively in regulatory inspections by European Competent Authorities, saving companies time and money.
Clinical Safety
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.
Pharmacovigilance
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.
Literature Search
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.
Aggregate 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.
Signal Detection
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.
Risk Management
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
Together, because safety is spontaneous
APCER’s 24×7 Integrated Response Center is staffed exclusively with healthcare professionals who are trained on your product and know how to respond appropriately to reports of serious adverse events (SAEs) by investigator sites and to spontaneous reports of post-market adverse events. The IRC can also handle medical inquiries and product complaints as a seamless pharmaceutical contact center.
APCER is experienced in qualifying SAEs as SUSARs. When expedited reporting is required, we remain in communication with you and your CRO as timelines and relevant competent authorities, sites, IRBs, and ethics committees are determined. We are skilled in blinding/unblinding issues and submitting to the Eudravigilance Clinical Trial Module in E2B format.
