Doing It Right: The Rigorous Approach to Medical Literature Monitoring for Drug Safety
August 24, 2020
Download the whitepapers:
Medical literature monitoring has an additional layer of complexity, added by the processes and software used to carry out the task more efficiently. Here, regulations demand high levels of rigour and quality management, with both people and technology required to operate to detailed and demanding standards. And from search strategies to deduplication algorithms, everything has to be up to date and fit for regulatory inspection at any time.
PV failings have serious consequences that extend all the way up to billion-dollar lawsuits and the withdrawal of drugs from the market. Pharmaceutical companies face a dilemma. What’s more painful, the fines for non-compliance or the cost of doing it right?
Today, there’s a body of best practice and technology that can significantly reduce the pain of medical literature monitoring in PV, making this dilemma unnecessary. In our new whitepaper series, we provide best practice advice and guidance for medical literature monitoring’s three key issues:
- Search: Better Relevance: How precision search reduces the cost, effort and risk in medical literature monitoring
- Duplicate references: Finding the One: How to manage the impact of duplicate references in medical literature monitoring
- Validation and quality: When Best is not Enough: How to ensure pharmacovigilance solutions meet essential Quality management and validation standards
From best practices to algorithms, software to sources, we set out best practice for how medical literature monitoring can be done right – without the cost, time and effort that is such a daunting prospect for many pharmaceutical companies.
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