Data as a Strategic Asset in the Life Sciences: Building in the Right Processes and Support for Data Quality, Standards, and Governance
Imagine this hypothetical scenario, which is not farfetched in the life sciences industry. Let us assume there is a safety event in a market due to a contaminated drug product and the health authority in that market issues a recall. If the drug sponsor would like to proactively withdraw it from all markets and if the company does not have good data about which markets receive the product from a specific manufacturing site, then the sponsor is likely to be impacted by a number of challenges including loss of revenues, compliance and/or reputation risk, and potential penalties.
The information about market approvals and product manufacturing sites related to approvals is usually managed by regulatory in what is called a Regulatory Information Management (RIM) system.
A recent article in Forbes stated that “While industries such as financial services have had a long track record of managing data, and applying analytics to optimizing customer relationships and developing new services, life sciences companies have only in recent years begun to fully embrace and seize upon the opportunities to organize and apply their data in a systematic way to a range of drug development and patient care challenges.” While the life sciences industry has begun to see the advantages of treating data as a strategic asset, pockets of the industry have always played a key role around data as a strategic asset. For example, the clinical function, due to its very data-driven nature, has always focused significantly on data as a strategic asset given that the safety and efficacy profile of a drug largely depend on good data management practices.
Read the full article on Pharmaceutical Commerce.