Case Study: The “Easy” Button for eTMF Classification Using AI to Streamline Classification of Clinical Trial Documents
Posted by Keith P.Court Square Group, Inc.
159 days ago
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Court Square Group, Inc.
Court Square Group, Inc.
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Clinical Research *
Clinical Reporting
9
Abstract & Poster Development
3
Clinical Study Report Writing
7
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1
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204
Analytical Methods Development
1
Clinical Research
120
Clinical Research Network Development
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Show More (4)
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Drug Product Manufacturing
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Formulation Development
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Show Less (4)
Real World Data Research
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Analytics Methods Development
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3
Evidence Prioritization
1
Late Phase Data Curation
7
Lifecycle Evidence Generation
2
Show More (1)
Observational Research
14
Show Less (1)
Study Operations & Management
113
Patient Recruitment
20
Site Contracting & Payments
2
Site Identification & Activation
11
Site Relationship Management
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Study Tracking & Analytics
79
Show More (1)
Trial Implementation
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Show Less (1)
Trial Design & Planning
65
Data Management Planning
7
Enrollment Analytics
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Patient Recruitment Planning
43
Protocol Feasibility Planning
7
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Show More (1)
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Show Less (1)
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Brand Planning & Activation
15
Brand Vision & Positioning
7
Campaign Concept Testing
1
Multi-Channel Campaign Launch
7
Customer Engagement
46
Omnichannel Optimization
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Patient Facing Solution Design
16
Patient Journey Analysis
7
Retention Program Effectiveness
11
Show More (1)
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8
Billing & Reporting Operations
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Launch Sequencing
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2
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Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
1
Evidence Generation
101
Clinical Trial Concepts
15
Health Economics Modeling
60
Internal Medical Education
20
Patient Journey Mapping
3
Research Gap Analysis
5
Scientific Communications Development
10
Market Access Advisory Panels
2
Payer Advisory Board Strategy
9
Strategic Communications Planning
32
Competitive Publications Analysis
5
Publication Planning
4
Scientific Platform Planning
24
Strategic Stakeholder Engagement
68
Advisory Board Strategy
41
KOL Relationship Management
8
Stakeholder Influence Mapping
29
Pharmacovigilance *
Risk Management
22
Risk Evaluation & Minimization
19
Risk Management Evaluation
5
Safety Communications
3
Safety Systems
85
Safety Data Analytics
35
Safety Data Intake & Triage
33
Safety Signal Evaluation
25
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13
Calibration & PM Programs
1
Deviation Investigations
0
Equipment Maintenance
0
Facility Maintenance Programs
8
Facility Security Management
4
Production & Supply Chain
54
Clinical & Commercial Production
28
Labeling & Packaging
17
Storage & Distribution
22
Quality Management
82
Corrective Action Verification
51
Deviation Investigation
8
Quality Process Governance
25
Testing & Release
16
Batch Release Testing
2
Raw Material Testing
12
Stability Program Testing
3
Regulatory *
Compliance
153
Agency Meeting Support
45
Dossier & Application Development
22
eCTD Publishing & Validation
10
Pre-Submission Advisory Meetings
2
Regulatory Compliance
89
Labeling & Promotions
2
Core Data Sheet Management
1
Labeling Strategy Development
1
Maintenance & Renewals
9
Post-Approval Safety Reporting
4
Promotional Material Compliance
4
Variations & Supplements
3
Transparency & Disclosure
4
Clinical Disclosure
2
Clinical Transparency
3
Technology & Operations *
Automation & Efficiency
8
Clinical Data Automation
6
Lab Automation Systems
1
Supply Chain Automation
1
Data & Analytics
80
Advanced Analytics
34
Artificial Intelligence
1
Data Curation
8
Data Visualization
44
Digital Health Solutions
75
5G Infrastructure
3
Blockchain Applications
0
mHealth Applications
5
Patient Portals
24
Telemedicine Platforms
22
Show More (1)
Wearables & Sensors
23
Show Less (1)
Early Development
3
Clinical Supply Chain Automation
1
Clinical Trial Management Systems
2
Informatics Infrastructure
74
Cloud Computing Systems
51
Data Security Solutions
17
Data Storage Platforms
8
Operations
61
Communications
1
Communications & Corporate Affairs
0
Content Creation & Development
6
Human Resources & Talent Acquisition
27
Management Consulting
2
Show More (7)
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Court Square Group, Inc.
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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