The Big Picture in Safety, Part 3 of 4: Taking the Pain Out of Safety Data Management Leads to Better Quality
Oct 04, 2016
The third in our four-part series on the importance and opportunities of a Total Safety approach to pharmacovigilance explores quality management.
With pharmacovigilance data coming from multiple and different sources, the information in individual case safety reports and other data is often a percentage of what it could /should be. Therefore it’s imperative that companies have good end to end data quality management.
Furthermore, many regulations, particularly in Europe, put the onus on companies to proactively adopt and document a comprehensive quality lifecycle view of the entire quality management system. This quality overview needs to include both staff and processes in order to monitor, manage and improve pharmacovigilance operational processes.
Quality management is a broadly encompassing term that spans quality planning, quality control, quality assurance and quality improvements.
A total safety solution and approach, therefore, should include built-in quality measures as well as configurable quality metrics. For example, paperless processing with end-to-end functionality can reduce manual handovers between affiliates and headquarters, which not only helps to improve case management but improves quality oversight, while minimizing the risk of error.
A frequent challenge for companies is managing the case quality from different partners, both internal and external (including contract research organizations and affiliates). Integrated validations and checklists can help to automate quality management of these case reports. To ensure continual quality improvements, the use of quality monitoring dashboards and built-in compliance and consistency checks can make a significant difference.
Configurable quality metrics, meanwhile, can make it easier to define custom metrics, evaluate quality statistics, help with signal and trend analysis and improve training and process evaluation.
As the emphasis on quality as integral to safety data management increases, companies will need to ensure they are able to meet their obligations.
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