Safety

APCER offers complete, cost-effective, and agile solutions to challenges in clinical safety and pharmacovigilance. We tailor our resources to meet your budget and fit your culture.

The focus of drug safety and pharmacovigilance 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.

• Clinical Safety
• Pharmacovigilance
• Literature Search
• Aggregate Reporting
• Signal Detection
• Risk Management

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.

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.