Data collection

Optimizing the Collection of Input Information with VigiDirect 

Gathering accurate and comprehensive input information is the first step in pharmacovigilance processes. It includes literature screening (both local and global), spontaneous reports, clinical trial data, post-marketing surveillance, regulatory databases, and signal detection activities, as outlined in Good Pharmacovigilance Practices (GVP) Module VI and IX for medicinal products, and in Regulation (EU) 2017/745 (MDR) and ISO 13485 for medical devices. 

VigiDirect is designed to enhance efficiency in monitoring, assessing, and documenting these diverse sources of safety information. By implementing smart workflows that inherently include medical assessment of data, VigiDirect supports companies in reducing the risk of errors, deviations, and unnecessary costs, while maintaining reliable, real-time safety data for regulatory compliance. In the context of medical device vigilance, this means enabling structured collection and assessment of incidents, adverse events, and PMS data, ensuring compliance with MDR vigilance reporting timelines and risk-based decision-making under ISO 14971. By integrating advanced automation and expert validation, VigiDirect helps ensure that organizations have accurate, up-to-date vigilance data readily available for regulatory submissions, audits, and proactive risk management.

Data Collection as the Foundations of Risk-benefit analyses

In both pharmacovigilance and medical device vigilance, proper data collection is crucial for ensuring patient safety, regulatory compliance, and effective risk management. The way safety data is gathered and processed directly impacts the accuracy of risk assessment, signal detection, trend analysis, and regulatory reporting. If input data is incomplete, inconsistent, or delayed, it can lead to misinterpretation of safety signals and affect the establishment of an accurate risk profile of a medicinal product or medical device. For medical devices, data collection have to also support post-market surveillance (PMS) obligations, including monitoring of incidents, field safety corrective actions (FSCAs), and complaint trends, as required under Regulation (EU) 2017/745 (MDR) and ISO 13485.

That’s why it is essential to have well-defined processes and systems in place to ensure high-quality data collection, allowing for timely risk evaluation and effective decision-making. For medical devices, this means systematically capturing real-world performance data, analyzing adverse event reports, and identifying potential risks early through trend reporting (Article 88 MDR) and risk management practices aligned with ISO 14971. Properly structured data collection not only improves regulatory compliance with EU-GVP for pharmaceuticals and MDR vigilance requirements for medical devices but also enhances overall safety monitoring and patient protection. By implementing automated systems, predefined workflows, and data validation mechanisms, companies can reduce the risk of errors and ensure that risk-benefit assessments remain scientifically robust and compliant.