Data Standardization For Late Stage Development And Periapproval Studies

Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources, we find products are commercialized and made available in new markets – having a strong real-world infrastructure to accommodate all these sources, modalities, and connections is of great importance to your late stage development evidence-generation strategy.

Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.