Data Standards and Exports Solution Brief

The lack of standards implementation is costing, on average, an estimated $9 million per trial in direct costs, reducing the potential to shorten the duration of clinical trials by 60%. A great deal of these direct costs is taken up with the expensive process of converting source data to CDISC SDTM.

In fact, according to one survey, over 65% of organizations take more than one month from database lock to generate SDTM data sets. Most of this is due to manual data standardization at the end of the study to CDISC standards, resulting in drug launch delays, leading to lost revenue and increasing trial costs.

Using automated, integrated, validated data standards, data mapping and export tools that are integrated within electronic data capture (EDC) system allows for earlier data management and cleaner data, with resulting SDTM datasets available shortly after database lock.

Learn how OmniComm's TrialMasterĀ® EDC can automate the creation of SDTM datasets thereby reducing study timelines and costs while improving data quality and integrity.

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Data Standards and Exports Solution Brief