Situation

A fortune 500 company needed to provide a secure environment to access and review documents in order to determine documents for submission to the FDA. This was needed to ensure government regulatory compliance and to provide access to scientific literature to support regulatory compliance.

The client had an existing, long-term relationship with TCDI and voiced their concerns over the current process. TCDI was able to build a system that eliminated waste, ultimately saving time and money for the client.

3 Custom Solutions
with Built-In Tools and Custom Workflows

Built-In Collaboration
Allowing Access to Review Documents and Work as a Team
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Impact

Prior to TCDI’s solution the client team was completing daily manual document searches on literature sites in order to obtain the necessary literature for their research. The client had created a number of internal databases and applications for separate documents and data storage and were gathering documents from these various locations in order to prepare a submission.
 
This workflow was cumbersome and unsustainable. It required many hours of manual labor to complete the necessary research across internal documents and public documents and literature. There was also a great deal of redundancy in the storage of data and documents.
 
All of this combined to make it difficult for the client to keep up with the manual tasks needed for research and preparing submissions.

Resolution

TCDI worked closely with the client to develop an integrated team solution. After attending working sessions for the design and planning of the system and frequent check-ins throughout the implementation process, TCDI created:
 
  • A CVLynx site to provide access to all documents in one location. This included company documents, literature, related metadata and research, and work product.
  • A polling service to search for newly published articles to make available on the CVLynx site and created built in links to various publication sites.
  • A secondary highly restricted CVLynx site for Ultra Trade Secret documents and created a sync process that made necessary literature and documents available in the Ultra Trade Secret system, eliminating the need for users to go to multiple locations to complete their research.
 
The built in tools combined with configured workflows enable review of the documents and production of the documents for government submissions.
 
The initial setup and population of initial documents and literature only took a couple of months, however, the client expanded the project to migrate a number of their separate databases, applications, spreadsheets, and one website.

Results

Ultimately, TCDI was able to eliminate redundancy and decrease costs for the client by creating an easy to use, one stop shop for access to all relevant materials and built in collaboration tools that allowed groups to access, review and work together as a team.

TCDI’s partnership allowed the client to complete their work more efficiently and effectively. The project even led the client to expand upon their original request and migrate more internal databases into the environment in order to utilize the many tools available in CVLynx.

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