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Court Square Group, Inc.
Court Square Group, Inc.
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Projects
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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About
1995
1350 Main Street, Springfield, MA 01103 1656, USA
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Case Study: The “Easy” Button for eTMF Classification Using AI to Streamline Classification of Clinical Trial Documents
Keith P.
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
Keith P.
Andy S.
Court Square Group company overview
Case Study: SAP S/4HANA Implementation Success Brings Penicillin Production Back to the United States
Andy S.
Case Study: SAP S/4HANA Implementation Success Brings Penicillin Production Back to the United States. Migration and implementation of a robust SAP S/4HANA 1709 solution in just 16 weeks.
Innovative Voice and Video Solution Captures Patient– Clinician Interactions And Clinical Data To Improve Clinical Trials
Andy S.
Innovative Voice and Video Solution Captures Patient– Clinician Interactions and Clinical Data To Improve Clinical Trials Leading clinical management solution provider group taps Court Square to provide a 21 CFR Part 11 voice and video solution for rating patient–clinician interactions, using off-the-shelf tools.
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