Pharmacovigilance Agreement Management

ADRium™ Agreements is a tool within our ADRium™ PV suite and PVaaS cloud-based platform designed to streamline the management of Pharmacovigilance Agreements (PVAs) for biopharmaceutical companies. This tool simplifies complex PVA processes, ensuring compliance and enhancing efficiency through user-friendly features and robust support.

Streamline PVA management with a dedicated tool

ADRium™ Agreements showcases how effective management of PVAs can enhance regulatory workflows. Our platform enables clients to efficiently handle the entire agreement lifecycle, from drafting and tracking to compliance reporting. The examples below reveal how ADRium™ Agreements improves agreement handling and adherence.

Streamline PVA creation and partner integration

Utilize in-built templates with dynamic content to draft agreements and efficiently capture local PV requirements
Manage partner information and track PVA statuses seamlessly
Facilitate faster contract processing and approval through integrated workflows

Enhance contract processing

Oversee drafts, reviews, and negotiations with a unified system
Securely finalize agreements using digital signatures or DocuSign for compliant, efficient processing

Enhance data exchange and visibility

Connect with PV safety databases to automate adverse event reporting and reconcile data monthly
Generate detailed reports and dashboards for PVA metrics, partner lists, and product information, with notifications for periodic reviews

Ensure secure access and detailed auditing

Implement access controls to safeguard sensitive information
Maintain a detailed audit trail for transparency and regulatory compliance

Frequently asked questions

What are Pharmacovigilance Agreements (PVAs)?

Pharmacovigilance Agreements (PVAs) are contracts between parties involved in drug development and distribution. They outline how adverse drug events will be monitored and reported to ensure safety and compliance with regulations.

Why are Pharmacovigilance Agreements important?

PVAs are crucial for ensuring that all parties involved in drug development and distribution adhere to safety regulations. They help ensure that adverse events are reported accurately and promptly, which is essential for maintaining drug safety and regulatory compliance.

How can managing PVAs be simplified?

Managing PVAs can be simplified by using tools that provide templates for drafting agreements, track agreement status, and facilitate digital signatures. These tools help streamline the agreement process, making it more efficient and ensuring compliance with regulatory requirements.

What features should a PVA management tool have?

A good PVA management tool should have features like easy-to-use templates, tracking and reporting capabilities, secure digital processing, and integration with safety databases. These features help manage the agreement lifecycle more effectively.

How can I ensure data security when managing PVAs?

Ensuring data security involves using tools that offer strong access controls, encryption, and detailed audit trails. These measures protect sensitive information and help maintain compliance with data protection regulations.

What is ADRium™ Agreements and how does it help with PVAs?

ADRium™ Agreements is a cloud-based tool designed to manage Pharmacovigilance Agreements (PVAs). It helps streamline the PVA process with features like customizable templates, digital signatures, and integration with safety databases, making it easier to draft, track, and report on PVAs while ensuring compliance and data security.

“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.”

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Streamline PVA management with a dedicated tool

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