Fit-for-Purpose Signal Detection Solutions for Pharmacovigilance

Effective pharmacovigilance demands continuous monitoring of drug safety signals, a critical process that ensures accurate benefit-risk assessment while meeting global regulatory requirements. This paper examines the fundamental importance of signal detection methodologies and describes how Qinecsa’s Signal Detection as a Service (QSDaaS) empowers pharmaceutical teams to implement proactive risk management strategies that enhance patient safety and […]

Building an Automation and AI Culture

Written by Martin Holm-Petersen, Chief Strategy Officer Preamble This will be the first in a series of articles about the application of artificial intelligence (AI) and advanced automation in our industry, with a focus on the pharmacovigilance (PV) use-case. The intention of the series of article is to explain the current state of automation and the issues […]

Reportum PV Design Studio

Using our PV Design Studio, Reportum offers configurable forms tailored to your use cases and workflows, allowing you to capture data from all sources. With our deep pharmacovigilance expertise, Qinecsa ensures precise data capture tailored to your needs using, delivering data directly to your safety database.

What is Pharmacovigilance?

Pharmacovigilance is a critical component of the medicinal product lifecycle, focusing on ensuring the safety and efficacy of medicinal products from pre-clinical development through post-marketing surveillance. The primary goals of pharmacovigilance are to enhance patient safety, manage risks, and strengthen public health and trust in therapeutic products. Regulatory bodies mandate rigorous vigilance to detect and […]

Streamline AE, PQC & MI call handling operations with Reportum

Call centres are typically responsible for a high percentage of safety report entry. However, the nature of the reporting process means it is hard to control, often involving complex fixed pdf forms that can lead to incomplete data and require follow-up to achieve the desired level of data quality. Reportum® is a highly scalable, centralised […]

Standardise safety data collection with Reportum

Understanding patient safety is an essential element of Patient Support Programs. However, traditional safety reporting systems involve multi-step manual processes that often result in compliance failures and late or unreported cases. Reportum® is a highly scalable, centralised solution that assists PSP nurse and call centre reporting to ensure standardised and complete data capture across third-party […]

Simplify safety reporting on-the-go with Reportum

Safety reporting is not a core focus for field-based staff, therefore inputting of reports is often completed at a later time. This means report entry is frequently incomplete and often delayed, which puts pressure on the safety team to comply with required timelines. Reportum® offers a simple, easy-to-use interface that guides the capture of relevant, […]

Capture patient data direct from source with Reportum

A complete picture of drug safety cannot be created if only part of the available data is captured, however the current adverse event capture process involves a maze of reporting routes across pharma companies and regional regulators. This creates a barrier to reporting, resulting in adverse events going unreported. Reportum® enables pharma to provide an […]

End-to-end PV Solutions: Small Pharma & Biotech

Through the input of industry leader members of the PV Insights Network, Qinecsa focuses on providing solutions to the safety challenges facing small pharmaceutical and biotech companies. With the acquisition of Insife, we have further expanded our services to address these unique end-to-end PV needs.  

Standardizing and improving safety surveillance with Vigilance Workbench

A top 10 pharma company faced challenges in standardizing safety surveillance across Pharma, Vaccine, and Consumer Health units, including consolidating signal teams, facilitating a divestment, integrating multiple data sources, migrating data from legacy systems, replacing existing methods, and simplifying the IT landscape. The timely deployment of Qinecsa’s Vigilance Workbench significantly benefited the client by increasing […]