Adverse Events Intake

Optimize regulatory compliance and customer support with expert management of Adverse Events (AEs), Product Quality Complaints (PQCs), and Medical Information Inquiries. ADRium™ Intake enhances your signal management processes with streamlined workflows, seamless integrations, and real-time analytics to ensure thorough evaluation and compliance.

Simplify adverse event management with ADRium™ Intake

ADRium™ Intake improves the handling of adverse events and quality complaints by integrating customizable workflows and automation. Clients benefit from enhanced regulatory compliance and operational efficiency. Explore how our adverse events intake solution supports effective safety management through the examples below.

Stay informed with timely, accurate notifications

Automatically send notifications to consumers and reporters for seamless communication
Receive real-time alerts on adverse event status and case updates
Maintain regulatory compliance by keeping all stakeholders informed

Enhance safety operations with an integrated workflow

Integrate seamlessly with Pharmacovigilance (PV) and Quality Management systems to streamline case handling
Minimize manual entry and reduce errors by linking key systems together
Ensure data consistency and compliance across all platforms

Tailor workflows to your specific needs

Set up dynamic workflows for efficient processing of adverse events
Customize workflows to adapt to changing requirements or case complexities
Improve operational efficiency and decision-making with adaptable, automated processes

Enable efficient case management with a ticketing system

Provide partners and customers with a ticketing interface for tracking events
Assign and track tasks related to adverse event processing in real-time
Enhance communication and collaboration between internal teams and external stakeholders

Gain actionable insights with comprehensive monitoring tools

Access real-time dashboards and reporting for complete visibility into adverse event intake
Track case status, processing times, and trends to optimize safety management
Generate detailed reports to support decision-making and ensure compliance with industry standards

why synapmed?

Synapmed combines advanced AI and data analytics technology with expert support to streamline adverse event intake and management. ADRium™ Intake offers real-time monitoring, dynamic workflows, and seamless system integrations, ensuring efficient and accurate case processing.

Our experienced team utilizes cutting-edge intelligent automation tools to enhance regulatory compliance and case management, helping you bring safe, effective products to market with confidence. From system integration to actionable insights, Synapmed is your partner in achieving operational excellence.

Frequently asked questions

What is adverse event management?

Adverse event management involves monitoring, reporting, and analyzing negative effects or reactions associated with drug products. It is crucial for ensuring drug safety and regulatory compliance by documenting and addressing any issues that arise.

Why is it important to manage product quality complaints (PQCs)?

Managing product quality complaints is important to ensure that any defects or issues with a product are identified and addressed promptly. It helps maintain product safety, meet regulatory requirements, and improve customer satisfaction.

How can an automated intake solution enhance adverse event and PQC management?

An automated intake solution enhances management by offering features like automated notifications, customizable workflows, and seamless integrations with other systems. These features streamline the process, reduce manual entry errors, and ensure thorough and compliant handling of adverse events and quality complaints.

What are dynamic and customizable workflows?

Dynamic and customizable workflows are processes that can be tailored to meet specific needs and adapt to changing requirements. They help automate and streamline the handling of adverse events and complaints, improving efficiency and accuracy in case processing.

How does real-time monitoring and analytics benefit adverse event management?

Real-time monitoring and analytics provide immediate visibility into the status and trends of adverse events and complaints. This allows for timely decision-making, efficient case management, and enhanced regulatory compliance by tracking key metrics and generating actionable insights.

What is ADRium™ Intake and how does it support adverse event and PQC management?

ADRium™ Intake is an automated case intake solution developed by Synapmed designed to optimize the management of adverse events, product quality complaints, and medical information inquiries. It supports these processes through streamlined workflows, seamless system integrations, and real-time analytics, ensuring efficient case handling and regulatory compliance. The solution enhances safety operations with features like automated notifications, customizable workflows, and comprehensive monitoring tools.

“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.”

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.

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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.

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