Providing audit ready visibility into an artifact's status, that is not yet filed in the eTMF.
A leading global contract research organization (CRO) was manually uploading site documents and associated metadata into their eTMF. Due to the complexity of study startup (SSU) and variability of regulatory requirements for study countries and therapeutic areas, determining when all the documents needed for filing existed in the eTMF without multiple QC checks was a time consuming and burdensome activity. As the organization scaled with additional study volume, the efficiency and quality of the data going into the eTMF was causing audit risk and increasing FTE costs.
The CRO applied regulatory related knowledge for each study-country and therapeutic area to identify artifacts and appropriate metadata that needed to be in present in the eTMF for each study-site by using goBalto's Activate to guide the start startup workflows, documents and submission collections, with mappings to the DIA reference model. By utilizing Wingspan's APIs artifacts and metadata were transferred to the eTMF only when specific business conditions/events occurred in Activate.
Vice President, Product Management
"Using the Wingspan API, documents that have already gone through QC in Activate can be placed directly into a final state in eTMF without any need for manual processing. The API ensures quality by filing documents to the appropriate location in eTMF and confirming that all required metadata is present and valid."
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