• About Us
  • Services
    • Pharmacovigilance
    • Medical Information
    • Regulatory Affairs
    • Medical Writing
    • Medical Affairs
  • Specialty Areas
    • ATMPs
    • Medical Devices
  • Insights
    • Brochures
    • Case Studies
    • Videos
    • Articles
    • Whitepapers
    • Blogs
    • Webinar Recordings
    • Infographics
  • News & Events
  • Careers
  • Contact Us
December 2, 2020

Together for
minimizing risks

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

Know more →

pharmacovigilance companies in usa

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.

A Model for Clinical Safety
The Need for Vigilance
FAQs about Pharmacovigilance

Explore More

  • April 21, 2022

    Scaling up to address safety challenges for an Oncology product


    View more
  • March 8, 2021

    End-to-end pharmacovigilance support for a UK-based pharmaceutical company


    View more
  • March 8, 2021

    Setting up Agile PV operations for a US based Pharma company


    View more
  • March 8, 2021

    Enabling compliance through strong PSMF management & QPPV oversight


    View more
  • March 8, 2021

    Established a unified, global PV system for a pharma company after multiple M&A


    View more
  • March 8, 2021

    Enabling global expansion by establishing an integrated PV system


    View more
  • March 8, 2021

    Active remediation measures help mitigate major safety findings


    View more
  • March 8, 2021

    Efficient Risk Management Support for Marketing Authorization Applications in LATAM Region for a Leading Pharma Company


    View more
  • March 8, 2021

    Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards


    View more
  • March 8, 2021

    GCP Audits in EU requiring local language competency for a biopharma company


    View more
  • March 8, 2021

    Significance of Medical Monitoring in smooth progression of clinical trials


    View more
  • March 8, 2021

    Bridging the gaps and inconsistencies within CT program through an expert overlay of medical monitors


    View more
  • March 8, 2021

    Top 20 Pharmaceutical Innovator Raises Standards and Reduces Costs with Support from APCER Life Sciences


    View more
  • March 8, 2021

    Innovative Biotechnology Company Relies on APCER Life Sciences to Manage Complex Safety Reporting in Oncology Trials


    View more
  • January 12, 2021

    Importance of Engaging a Safety Partner Early in the Drug Life Cycle


    View more
  • January 10, 2021

    Risk minimisation measures: Tracking and effectiveness assessment


    View more
  • January 6, 2021

    RMP Team Collaboration Across Functions


    View more
  • January 6, 2021

    aRMM Implementation Strategy


    View more
  • January 6, 2021

    Identification of risks and determination of aRRM requirement


    View more
View more

Testimonials

  • Medical Director
    APCER’s speed, responsiveness and flexibility to meet our safety needs is something we have always valued. APCER has helped harmonize our global pharmacovigilance operations and made us compliant with ever changing regulations.
    Medical Director
    US-based specialty pharmaceutical company
  • QPPV and Pharmacovigilance Head
    The audit was carried out professionally and objectively. The scope of the audit was relevant and appropriate, and time efficient. The discussions during the audit were constructive and recommendations where helpful and appropriate. The team members involved in the audit had a positive experience and were made to feel at ease by the auditors.
    QPPV and Pharmacovigilance Head
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company
  • Head, Clinical Trial Transparency
    APCER’s invaluable support with Clinical trial disclosure deadlines helped us in timely submissions of periodic reports.
    Head, Clinical Trial Transparency
    Top 10 pharmaceutical company with operations in the EU and US
  • AVP, Pharmacovigilance
    We appreciate APCER for its efficiency in responding to matters that they get even at the eleventh hour. Working with APCER has made compliance a lot easier.
    AVP, Pharmacovigilance
    US-based pharmaceutical company
  • Senior Director
    We are thankful to team APCER for bringing in strong practices & helping inspection readiness in our pharmacovigilance framework which led to successful FDA audits.
    Senior Director
    US-based pharmaceutical company

How can we work together for better health?

    Please note that by submitting this form, you consent to your personal data being processed in alignment with our Privacy Policy. APCER is committed to ensuring the security and protection of your personal information. Your personal data will be processed for purpose of facilitating your request and may be used for sending you additional marketing and business development-related information about APCER Life Sciences, its affiliates and our services. You can withdraw your consent by writing to us at DPO@apcerls.com.

    Share

    APCER Life Sciences is committed to improving health in partnership with its clients. We bring together safety, medical, regulatory and technology resources to ensure that patients receive the safest, most effective therapies possible.

    ©2021 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement

    Services

    • Pharmacovigilance
    • Medical Information
    • Medical Writing
    • Regulatory Affairs
    • Medical Affairs
    • Quality Assurance

    Specialty Areas

    • ATMPs

    Insights

    • Brochures
    • Case Studies
    • Videos
    • Articles
    • Whitepapers
    • Blogs

    Our response to COVID-19

    About Us

    • Leadership
    • Careers
    • Contact Us

    ©2021 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement
    Contact Us
    Contact Us
    • Have any questions?
    • (+1) 609 375 8906
    • info@apcerls.com