Health authorities around the globe are moving toward structured data submissions. The progression of the Identification of Medicinal Products (IDMP) standard is a great example of key product information that can be used throughout the product lifecycle. IDMP has motivated regulatory teams to start looking at where their data is stored, how it can be accessed, what formats it is in, and who owns it.
The Challenge
Critical regulatory submission documents like the Summary of Product Characteristics (SmPC) and the Package Insert (PI) possess large amounts of important product data but it is stored within the unstructured format of standard documents. This makes it difficult to access and even more difficult to use broadly, across the organization.
Adding complexity, product lifecycle data is dynamic. It changes regularly as a product moves through development and commercialization. Submission documents are updated with new data and new data elements. This data could be used to inform processes and support emerging data submission standards like IDMP if the data can be extracted and made more easily accessible.
Manually identifying these critical data elements within R&D documents is extremely time consuming. It also requires a knowledgeable resource who can review the content and discern where the data is located while understanding the context in which it is used. This situation creates a circular challenge. A knowledgeable resource is needed to accomplish this task but any knowledgeable resource on the team is going to be working on higher priority, and frankly, more compelling tasks.
This type of content review is tedious, time consuming, and error prone. When an experienced resource is employed for this task, it is also expensive.
