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This year, data curation will become as important as document authoring and sit at the core of companies that are nimbly adjusting to an ever-changing marketplace, writes John Lawrie.
Continuing this series of 2020 predictions for the life sciences industry by Veeva Systems, John Lawrie says that data curation will become as important as document authoring and sit at the core of companies that are nimbly adjusting to an ever-changing marketplace.
Global health authorities are driving sponsors to maintain and submit increasingly large data sets. This year, life sciences companies will evolve their business processes and operational frameworks to comply. A vast majority of companies still rely on email, manual processes, and physical hand-offs to capture, document, and share information1 – a workflow practice that is not sustainable as more regulatory controls are added throughout the supply chain.
For example, upcoming revisions to IDMP (Identification of Medicinal Products) and FDA’s PQ/CMC (Pharmaceutical Quality/Chemistry Manufacturing and Control) initiative will intensify the need for data that is structured, harmonized to global standards, and easily accessible. New organizational roles that bridge the gap between the data needed for submissions and how that information is managed today will be created to ensure compliance goals are met.
Data curation will become as important as document authoring, and sit at the core of companies that nimbly adjust to evolving compliance standards and an ever-changing marketplace. Roles such as data curator and data scientist, along with the creation of specialty innovation teams that address stakeholder information needs and opportunities, will grow in stature. This shift will accelerate time to market, eliminate waste, and enhance patient safety.
John Lawrie is VP, Veeva Vault RIM.
1. Veeva 2019 Unified Clinical Operations Survey Report.