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Automating Investigational Product Green Light Release to eTMF

by Craig Morgan
01May2017

Providing audit ready visibility into an artifact's status, that is not yet filed in the eTMF.

Case Study: Automating IP Green Light Release to eTMF

The Challenge

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.

Manual eTMF Process (Study Startup Docs)

The Solution

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.

Kathie Clark
KATHIE CLARK
Vice President, Product Management
Wingspan Technology
"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."

The Outcome

Find out now by downloading the case study, which shows the significant improvements in operational efficiencies the CRO has realized since integrating goBalto Activate with their enterprise eTMF.

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