Enhancing Pharmacovigilance with cubeSAFETY: A conversation with QVIS

Introduction

In the ever-evolving landscape of clinical research and pharmacovigilance, ensuring regulatory compliance while efficiently managing safety data is a top priority for pharmaceutical companies and contract research organizations (CROs).

QVIS, a Korean quality and pharmacovigilance specialist, has successfully integrated cubeSAFETY into its operations to streamline safety reporting, enhance data accuracy, and ensure seamless compliance with global regulations.

In this blog, we speak to Sumi Hyun, CEO and Founder of QVIS, to explore how cubeSAFETY has transformed their safety operations. 

Pharmacovigilance at QVIS: A commitment to compliance and safety

Could you describe your role at QVIS?

"I am responsible for overseeing pharmacovigilance activities at QVIS, ensuring compliance with global regulatory requirements, including FDA and MFDS reporting. My role involves managing safety data, implementing and optimizing safety systems, and coordinating with sponsors and CROs to maintain high standards in clinical trial safety and reporting."

What is your background in pharmacovigilance?

"I have been working in pharmacovigilance and clinical trial compliance for 20 years, with extensive experience in safety data management, regulatory reporting, and quality assurance. Throughout my career, I have collaborated with global pharmaceutical companies and CROs to enhance drug safety oversight."

Integrating cubeSAFETY into QVIS operations

What were the reasons for selecting cubeSAFETY as your safety reporting solution?

"We selected cubeSAFETY because of its robust compliance features, seamless integration with regulatory submission platforms, and its ability to handle large volumes of safety data efficiently. Its flexibility and automation capabilities significantly enhance our pharmacovigilance operations, improving data accuracy and regulatory compliance."

How was the implementation process?

"We implemented cubeSAFETY within QVIS with the support of CRScube. The implementation process was well-structured, allowing us to efficiently integrate cubeSAFETY into our pharmacovigilance workflow while maintaining compliance with regulatory requirements."

Achieving FDA electronic reporting success

You recently completed the FDA electronic reporting setup for a study in the US. How was the setup process?

"The setup process was carried out with the support of CRScube, ensuring compliance with FDA electronic submission requirements, including E2B(R3). Their expertise helped streamline the configuration and testing phases, allowing us to establish a robust and compliant electronic reporting system."

How do you know the setup was successful?

"The setup was confirmed successful through test submissions and acknowledgment receipts from the FDA, confirming the proper receipt and processing of our electronic reports."

How important is it for you to be able to submit AEs and SUSARs to the FDA electronically?

"It is critical for ensuring timely and compliant pharmacovigilance reporting. Efficient electronic submission minimizes delays, enhances data accuracy, and ensures regulatory adherence, ultimately contributing to patient safety and trial integrity."

Conclusion

QVIS’s experience with cubeSAFETY showcases the platform’s ability to streamline pharmacovigilance operations, ensure regulatory compliance, and enhance data accuracy.

With its robust automation and seamless integration with regulatory authorities, cubeSAFETY provides organizations like QVIS with the confidence and efficiency needed to manage safety reporting effectively.