Advancing the Future of Pharmacovigilance & Product Safety

At Synapmed, we’re continually enhancing our extensive pharmacovigilance technology solutions—from adverse event intake and ICSR processing to real-time signal detection and PVA management. We aim to help you meet the highest drug safety and regulatory standards efficiently and cost-effectively, ensuring safer patient outcomes and faster time to market for your products.

Deploy Advanced AI-Based Pharmacovigilance Solutions For Smarter, More Efficient Drug Safety

ADRium™ is a cutting-edge platform that leverages A.I. and intelligent automation, large language models (LLM), machine learning, and natural language processing (NLP) to streamline your pharmacovigilance processes. Improve safety surveillance and risk management for both clinical and commercial operations, all while keeping costs in check.

The Most Advanced, Robust, End-to-End PV Solution Suite In Life Sciences Today

ADRiumBOT™

ADRiumBOT is an AI tool designed to enhance the efficiency and scientific rigor of Pharmacovigilance case processing for Individual Case Safety Reports (ICSR). It utilizes AI technology and Large Language Models (LLM) to analyze incoming adverse event data, extracting critical information such as clinical manifestations, ICH E2B data fields, and patient demographics from source documents. The bot automates various workflows, including case book-in, duplicate checks, registration, triage, data entry, medical review, and causality assessment. ADRiumBOT employs Natural Language Processing (NLP) for coding and seriousness assessment using the MedDRA dictionary and Important Medical Events (IME) list, while also applying machine learning for causality assessment based on case narratives. Adhering to HIPAA standards for patient confidentiality, it operates as a browser extension, streamlining the ICSR process to reduce human effort and improve overall efficiency.

ADRium™ Intake

Process Raw Format Adverse Events
Process adverse events in any format and seamlessly transfer necessary cases to the ADRium Safety Module. Built-in workflows, real-time monitoring, and robust system integrations ensure efficient case management from start to finish.

ADRium™ Safety

Prevent AEs Proactively
Enhance safety surveillance and risk management with AI, machine learning, and NLP. Integrate adverse event information across all safety modules to proactively identify and address potential risks.

ADRium™ Signals

Real-Time Risk Management
Detect and manage safety signals in real-time. Comprehensive analytics and regulatory compliance features help you identify risks early and ensure patient safety.

ADRium™ Analytics

Visualize AE Data and Compliance Metrics
Analyze safety data thoroughly for informed decision-making. Generate reports quickly, track KPIs, and maintain regulatory compliance effortlessly.

ADRium™ Agreements

Simplify PVA Management
Draft, review, and share Pharmacovigilance Agreements with our cloud-based platform. Our Agreements module offers customizable templates, eSignature, and seamless database integration for hassle-free PVA management.

ADRium™ Literature

Retrieve Published Data Automatically
Automate the retrieval and review of published literature to ensure product safety and effectiveness. Streamline your workflows, reduce errors, and comply with audit-ready standards.

Medical Information Call Center (MICC)

Instant Access to Medical Expertise
Connect with our team for quick, accurate medical information. We streamline inquiries to support patient safety and regulatory compliance. Enhance your efficiency with our reliable, audit-ready service.

Pharmacovigilance SOLUTIONS

Simplify your pharmacovigilance with our expert solutions. We handle case processing, medical review, and risk management, seamlessly integrating with your systems to boost efficiency and accuracy. Our solutions cut manual errors, ensure timely reporting, and adapt to industry changes, enhancing your safety monitoring. Discover how Synapmed can improve your pharmacovigilance and deliver better results for your therapies and products.

PHARMACOVIGILANCE —
SHOULD YOU OUTSOURCE?

Navigating pharmacovigilance presents substantial challenges for life sciences companies, especially when interpreting the finer points of compliance. Failure to meet these stringent requirements can lead to severe consequences, including inspections or even revocation of marketing authorization. Companies face a critical decision: should they manage pharmacovigilance operations in-house or outsource to specialized firms? Each option has its own set of advantages and drawbacks, and understanding these is key to maintaining compliance and ensuring the safety of products on the market.

Dedicated to youR Projects

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. We’re a team that listens, pays attention to details, and brings smart insights to the table. We do it all so you can solve real problems throughout the product development and commercialization lifecycle.