NOVEMBER 2022LIFE SCIENCES REVIEW8DCompanies that embrace and prioritize unifying their data can meet compliance requirements and utilize trusted, curated data to unlock digital technology to improve processes and systemsata will continue to disrupt Regulatory processes and systems. There are several factors that drive this disruption such as granular data requirements from health authorities, financial pressure to do more with less, and organizational pressure to improve efficiency and quality. From compliance activities to process improvements, companies will need to unify their data to meet these demands.This should not be a surprise since the data and information that sponsor companies share with health authorities has become increasingly granular over the past 20 years. Initiatives like Structure Product Labeling (SPL), electronic Common Technical Document (eCTD), Study Data Tabulation Model (SDTM), Extended Medicinal Product Dictionary (xEVMPD), and Identification of Medicinal Products (IDMP) are examples of standards, guidance and regulations that drive the capture and exchange of structured drug and biologic data. These standards prompted the creation of databases, systems, and tools to store and submit data in a compliant manner to support narrative information delivered in documents.Seeing this you would think that there is a complete set of processes, systems, and standards for data intake, curation, storage, and transmission between sponsors, third party vendors and health authorities. Unfortunately, the truth is that there is still a long way to go. Information provided to health authorities (and internally at sponsor companies) is still primarily captured in documents ­ often in PDF format. Data sits in separate systems without common data definitions or governance models. Data is duplicated from system to system due the lack of a data model or interfaces between systems and databases. The lack of data governance and data sharing leads to companies spending time and resources on quality checks and validation (and re-validation) of data.By Scott Cleve, Vice President, Regulatory Operations and Compliance, Bluebird bioHOW TO MANAGE REGULATORY COMPLIANCEIN MY OPINION
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