Pharmacovigilance as a Service (PVaaS) Platform

ADRium™ Safety enhances your ability to manage Adverse Events (AEs), Product Quality Complaints (PQCs), and Medical Information Inquiries with advanced AI, PV operations-customized cloud SaaS and data analytics technology. This integrated PVaaS platform simplifies processes and boosts compliance, ensuring efficient safety surveillance and risk management for both clinical and marketed products.

Elevate your safety surveillance with innovative solutions

ADRium™ Safety demonstrates how integrating real-time data and analytics can transform pharmacovigilance practices. Our PVaaS platform supports proactive safety management and regulatory compliance. The examples below reveal how clients have leveraged ADRium™ Safety to improve their safety protocols.

Efficiently manage the full lifecycle of Adverse Events with automated and integrated tools

Automatically detect Adverse Events from structured and unstructured data sources
Capture AEs directly from reporters, healthcare professionals, or call centers
Process Individual Case Safety Reports (ICSRs) for timely assessment and submission
Generate periodic safety reports for comprehensive benefit-risk assessments

Leveraged advanced analytics and real-time signal detection for proactive safety management

Utilize detailed dashboards and compliance metrics to visualize and analyze Adverse Events
Detect safety signals in real-time for enhanced risk management
Leverage advanced analytics for improved decision-making and safety outcomes

Manage PVAs with streamlined workflows and compliance features

Manage and track Pharmacovigilance Agreements (PVA) efficiently with automated workflows
Ensure compliance with integrated tools and comprehensive reporting capabilities

why synapmed?

Synapmed’s PVaaS platform and ADRium™ solution suite provides unmatched pharmacovigilance capabilities with advanced AI and data analytics tools and expert support. Our technology ensures efficient management of Adverse Events and adherence to regulatory standards. With seamless workflows and timely insights, Synapmed helps you focus on enhancing product safety and effectiveness, confidently navigating complex safety data.

Frequently asked questions

What is pharmacovigilance and why is it important?

Pharmacovigilance refers to the processes and activities involved in detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. It is essential to ensure the safety of clinical and marketed products, minimize risks, and maintain regulatory compliance.

How are Adverse Events (AEs) managed in pharmacovigilance?

Adverse Events (AEs) are typically reported by healthcare professionals, patients, or manufacturers. They are collected, processed, assessed, and submitted to regulatory authorities in the form of Individual Case Safety Reports (ICSRs) to ensure timely risk management and compliance.

What are Individual Case Safety Reports (ICSRs)?

Individual Case Safety Reports (ICSRs) are detailed reports of adverse events experienced by patients. They play a critical role in the pharmacovigilance process by enabling timely analysis and submission of safety data to regulatory bodies.

How do companies ensure compliance with pharmacovigilance agreements (PVAs)?

Pharmacovigilance agreements (PVAs) outline the responsibilities and obligations of companies and partners regarding drug safety. Companies ensure compliance through structured workflows, tracking tools, and integrated reporting systems designed to meet regulatory standards.

What role do advanced analytics play in pharmacovigilance?

Advanced analytics in pharmacovigilance help detect patterns, identify safety signals, and assess risks more effectively. They enable proactive safety management by leveraging real-time data to improve decision-making and enhance overall product safety.

How does signal detection improve safety management?

Signal detection involves identifying potential safety concerns from adverse event data, enabling companies to take corrective action before more serious issues arise. This process helps reduce risks and ensure that medicines and therapies remain safe for use.

How does ADRium Safety streamline the Adverse Event (AE) detection and processing?

ADRium Safety allows users to automatically detect Adverse Events from both structured and unstructured data sources. The platform also supports the full lifecycle of AE management by capturing AEs from various sources, such as reporters, healthcare professionals, or call centers, and processing Individual Case Safety Reports (ICSRs) for timely assessment and regulatory submission.

What advanced analytics capabilities does ADRium Safety offer?

ADRium Safety leverages advanced analytics and real-time signal detection to enhance pharmacovigilance practices. With detailed dashboards and compliance metrics, users can visualize and analyze safety data, improving risk management and decision-making throughout the product lifecycle.

How does ADRium Safety manage Pharmacovigilance Agreements (PVAs)?

ADRium Safety enables efficient management of Pharmacovigilance Agreements (PVAs) by streamlining workflows and providing integrated compliance tools. The platform helps users track and manage PVA obligations, ensuring alignment with regulatory standards.

How does ADRium Safety help ensure compliance with regulatory requirements?

ADRium Safety is designed to meet global regulatory standards for pharmacovigilance. It ensures compliance by automating the reporting process, generating periodic safety reports, and providing real-time monitoring of compliance metrics, which helps companies meet submission deadlines and maintain product safety.

What kind of support does Synapmed offer for ADRium Safety?

Synapmed provides comprehensive support for ADRium Safety, including ongoing system updates and 24/7 customer service. The platform is continually enhanced to stay current with evolving regulations, ensuring users have the latest tools to manage safety surveillance effectively.

“Synapmed allows us to build expertise within our company while also outsourcing the administrative aspects. When you work with most vendors, it becomes an assembly line, and quality goes down. Or they take over completely, and we lose oversight. Synapmed is a part of my team, so we get to maintain and retain the quality.” 

“I build and fix departments and Synapmed has been part of that journey with me. We wanted to come up with a safety profile for one of our drugs. Because of the performance of competitor generics, it was getting a bad name. Synapmed mined the data, analyzed our product versus generics from a safety perspective, and wrote an article and abstract on the findings that was very productive.”

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 Project

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

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