Pharmacovigilance
ERIC Pharmacovigilance: Meeting Your Pharmacovigilance and Drug Safety Needs.
ERIC delivers tailored solutions to address your evolving pharmacovigilance and drug safety challenges. Through well-defined processes and seamless integration of data from diverse sources, we ensure robust safety monitoring.
By combining advanced technology with expert resources, we enhance efficiency, maintain compliance with stringent regulatory standards, and safeguard patient well-being.
Services We Offer
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1
Efficient Case Processing and Reporting
We specialize in streamlined case processing and accurate reporting, ensuring timely and precise handling of safety data. Our robust systems and expert oversight enhance compliance, improve efficiency, and support proactive risk management in pharmacovigilance.
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2
Comprehensive Serious Adverse Event (SAE) Management
We provide end-to-end Serious Adverse Event (SAE) management, ensuring timely detection, accurate reporting, and effective resolution. Our systematic approach enhances patient safety, maintains regulatory compliance, and supports robust risk management throughout the clinical trial process.
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3
Proactive Signal Management
We offer advanced signal management solutions designed to detect, assess, and mitigate potential safety signals early. Our systematic approach ensures timely identification of risks, supports data-driven decision-making, and maintains compliance with regulatory requirements, safeguarding patient safety throughout the product lifecycle.
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4
Expert Contributions to Safety Sections of Clinical Study Reports
We provide specialized expertise in developing and reviewing safety sections for clinical study reports. Our meticulous approach ensures accurate, comprehensive, and regulatory-compliant documentation, highlighting critical safety data and supporting informed decision-making for your clinical trials.
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5
Streamlined Preparation and Submission of Drug Safety Update Reports (DSURs)
We specialize in the efficient preparation and timely submission of Drug Safety Update Reports (DSURs), ensuring compliance with regulatory requirements. Our expert team delivers accurate, comprehensive, and well-organized reports, providing a clear overview of safety data and supporting ongoing risk-benefit assessments.
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Strategic Risk Management Planning and Implementation
We offer end-to-end risk management solutions, from meticulous planning to seamless implementation. Our proactive approach identifies, assesses, and mitigates potential risks, ensuring patient safety, regulatory compliance, and the successful execution of your clinical trials.
