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

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 looked at several large CROs and smaller drug safety firms, and APCER stood out for compliance with the regulatory requirements for pharmacovigilance, particularly in the EU where they have a strong audit history with the MHRA. The staffing of the team with appropriately knowledgeable medical personnel in our therapeutic area means the quality of their work product is high. We are adding more business, so we are clearly satisfied and look forward to building on our strong and positive relationship.

- Director, Drug Safety Operations, generic and specialty pharmaceutical 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

With APCER, we have access to the technical resources we need. They operate with professionalism, are always reachable, and provide robust responses with a quick turnaround time.

- Senior Director, Clinical Development, division of Top 10 global pharmaceutical company

Together, because safety is spontaneous

APCER's 24x7 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.

Download brochures
A Model for Clinical Safety
The Need for Vigilance

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Together, because pharmacovigilance requires a plan

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.

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