• About Us
  • Services
    • Integrated PV& MI
    • Pharmacovigilance
      • ICSR Case Processing
      • Literature Search
      • Aggregate Reporting
      • Signal Management
      • Risk Management
      • QPPV
      • PSMF
    • Medical Information
      • Integrated Response Center
      • Specialized REMS Contact Center
    • Regulatory Affairs
    • Medical Writing
    • Medical Affairs
    • Quality Assurance
  • Specialty Areas
    • ATMPs
    • Medical Devices
  • Insights
    • Brochures
    • Case Studies
    • Videos
    • Articles
    • Whitepapers
    • Blogs
    • Webinars
    • Infographics
  • News & Events
  • Careers
  • Contact Us
January 3, 2022

Together for
Steering Digital
Journeys

Technology

APCER provides complete, fully validated systems for case management, report generation, signal detection, electronic submissions, and regulatory tracking on a hosted basis, giving you a cost-effective alternative to installing and maintaining these systems in-house.

APCER also can integrate seamlessly with your systems to process adverse event cases, prepare and submit aggregate reports, or detect safety signals. We access our clients’ safety databases and other document sharing facilities through secure remote access, SharePoint, and secure FTP services. All information transfer is compliant with EU, US, and all relevant data privacy standards.

Safety Systems

APCER provides a completely managed solution in a multi-tenant environment with a separate database instance for each client.

Medical Information Systems

APCER hosts and uses agInguirer and IRMS to manage Medical Information workflow and documentation.

Signal Detection Software

APCER’s safety system includes a module for signal detection, which is used to support our signaling workflow.

Electronic Submissions

APCER has extensive expertise in electronic submission of expedited reports wherever these are accepted and can work with all types of gateways for undertaking electronic reporting.

Document Management

APCER maintains a production and document management system for compiling, reviewing and publishing regulatory submissions.

Data Migration

All migrations or routine data transfers are managed in a validated environment with full documentation from planning through user acceptance and go-live.

Together, to minimize risks

APCER’s global pharmacovigilance and regulatory platform is installed and operated within its own data center in the United Kingdom under the direction of the Managing Director. All technology systems are validated in accordance with 21 CFR Part 11 and GAMP-5.

APCER has the experienced staff to execute data migration and other database-related activities. All migrations or routine data transfers are managed in a validated environment with full documentation from planning through user acceptance and go-live. These activities ensure compliance and integration of safety data collected across the product lifecycle, from clinical trials to post marketing, and result in the ability to produce aggregate reports with signal detection in the proper format and content for periodic submission to regulatory authorities and other parties. APCER has a formal disaster recovery plan to ensure business continuity.

Tech_minimize.risks_

Testimonials

  • Medical Advisor, Medical Affairs
    I must commend the organizational skill, the professionalism, the clarity, the expertise on subject matter, execution excellence that APCER has exhibited in all my projects where I had collaborated…
    Medical Advisor, Medical Affairs
    A leading bio-pharma company
  • Global Clinical Leader
    My experience with APCER has been excellent. The team was very helpful, knowledgeable, responsive and professional with all the work that was needed.
    Global Clinical Leader
    A leading pharmaceutical company
  • Associate Submission Medical Writer
    APCER demonstrated extreme flexibility accommodating changes, and a number of last-minute changes were implemented quickly and correctly. I also appreciate the flexible communication during my workday, given the time zone differences between the APCER writers and myself.
    Associate Submission Medical Writer
    A leading bio-pharma company
  • 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
    pharmacovigilance companies in usa

    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.

    We are an ISO 9001:2015, ISO 27701:2019 and ISO 27001:2022 certified company.

    ©2025 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
    • Medical Devices

    Insights

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

    About Us

    • Leadership
    • Careers
    • Contact Us

    ©2023 APCER Life Sciences, Inc. All rights reserved. | Privacy Policy | Web User Agreement
    Contact Us
    Contact Us
    • Have any questions?
    • (+1) 609 455 1600
    • info@apcerls.com