SUMMARY

In order to meet their first FDA submission deadline a spin-off division of a large life science company needed to implement Electronic Document Management Systems (EDMS), electronic Common Technical Document (eCTD)solutions to manage their documents, clinical trial information, and FDA submissions. The division had a corporate directive to file their initial NDA (New Drug Application) with the FDA in less than a year. Due to already overstretched resources, the corporate IT department would not be able to initiate an evaluation or begin the implementation of EDMS and eCTD solutions for at least one year.

Court Square Group (CSG) implemented and hosted multiple applications within CSG’s Audit Ready Compliant Cloud™(ARCC) environment and provided a fully functioning submission environment in less than three months. Court Square Group’s solution enabled the client to implement, train and submit the necessary documentation to the FDA for their first approval even earlier than the anticipated deadline.

THE CLIENT

The client is a new pharmaceutical start-up division of a large medical device manufacturer that was tasked with producing the first pharmaceutical products for the company. The client had a drug candidate that they intended to bring to market within the year.

SUMMARY

A growing CRO recognized that the amount of time spent to ingest documents from multiple clinical sites over multiple trials significantly increased costs and project delays. As the number of trials expanded, the increase in costs and delays became even more troubling. The problem was compounded by a dwindling number of CRAs who possessed knowledge to classify these documents due to workforce challenges. The CRO set out to find a solution to more effectively utilize the people within the company.

ABOUT THE CLIENT

A growing CRO recognized that the amount of time spent to ingest documents from multiple clinical sites over multiple trials significantly increased costs and project delays. As the number of trials expanded, the increase in costs and delays became even more troubling. The problem was compounded by a dwindling number of CRAs who possessed knowledge to classify these documents due to workforce challenges. The CRO set out to find a solution to more effectively utilize the people within the company.

THE CHALLENGES

The first challenge was to ensure that the personnel reviewing the documents from the clinical sites were able to process those documents. Often, multiple documents were combined, scanned, saved in a single PDF and emailed to the CRAs. Extracting, separating, and determining what to do with each document was a very manual effort. CRAs needed to manually break up large files into several individual documents. After the documents were separated, CRAs needed to apply a standard naming convention.

Often clinical sites provided files with non-conforming file names. Once renamed, each document was filed into the appropriate location in the DIA eTMF file/folder structure. This labor-intensive process required knowledge of the overall eTMF structure and for the CRAs to read each document and determine the appropriate folder to store the document based on the content within.

THE SOLUTION

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