Rapid Application Integration and 21 CFR Part 11 Compliant Hosting
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Court Square Group, Inc.
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Rapid Application Integration and 21 CFR Part 11 Compliant Hosting
Court Square Group, Inc.
Court Square Group, Inc.
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Medical Affairs *
Scientific Communications Development
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Medical Writing
3
Payer Advisory Board Strategy
13
Market Access Advisory Panels
5
Strategic Stakeholder Engagement
72
KOL Relationship Management
15
Advisory Board Strategy
41
Stakeholder Influence Mapping
28
Defining the Value of Medical Affairs
3
Defining the Value of Medical Affairs
3
Evidence Generation
103
Clinical Trial Concepts
15
Internal Medical Education
22
Health Economics Modeling
60
Patient Journey Mapping
3
Research Gap Analysis
6
Strategic Communications Planning
36
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9
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25
Competitive Publications Analysis
5
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9
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Core Data Sheet Management
3
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117
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56
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26
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9
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133
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84
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17
Clinical Study Report Writing
11
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3
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261
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156
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6
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9
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4
Document Management
16
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Trial Design & Planning
85
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12
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8
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52
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150
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55
Advanced Analytics
89
Early Development
49
Clinical Trial Management Systems
46
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3
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101
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83
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83
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Category Selection:
Select any categories from those you have selected for your main listing. If you wish to include more categories, add them to your main listing first and after doing so, they will appear below.
Medical Affairs *
Scientific Communications Development
19
Medical Writing
3
Payer Advisory Board Strategy
13
Market Access Advisory Panels
5
Strategic Stakeholder Engagement
72
KOL Relationship Management
15
Advisory Board Strategy
41
Stakeholder Influence Mapping
28
Defining the Value of Medical Affairs
3
Defining the Value of Medical Affairs
3
Evidence Generation
103
Clinical Trial Concepts
15
Internal Medical Education
22
Health Economics Modeling
60
Patient Journey Mapping
3
Research Gap Analysis
6
Strategic Communications Planning
36
Publication Planning
9
Medical and Scientific Communications
0
Scientific Platform Planning
25
Competitive Publications Analysis
5
Regulatory *
Labeling & Promotions
9
Labeling Strategy Development
7
Core Data Sheet Management
3
Maintenance & Renewals
14
Variations & Supplements
4
Post-Approval Safety Reporting
7
Promotional Material Compliance
6
Compliance
187
Regulatory Compliance
117
Dossier & Application Development
30
Pre-Submission Advisory Meetings
8
eCTD Publishing & Validation
16
Agency Meeting Support
56
Show More (1)
Structured Content Authoring
2
Show Less (1)
Transparency & Disclosure
8
Clinical Disclosure
3
Clinical Transparency
7
Commercialization *
Customer Engagement
49
Patient Engagement
7
Patient Facing Solution Design
15
Patient Journey Analysis
8
Omnichannel Optimization
14
Strategic Account Management
1
Show More (1)
Retention Program Effectiveness
10
Show Less (1)
Brand Planning & Activation
17
Campaign Concept Testing
3
Multi-Channel Campaign Launch
7
Brand Vision & Positioning
7
Market Access & Policy *
Government Policy
2
Legislative Monitoring
2
Advocacy Management
1
Global Market Access
56
Payer Evidence Generation
4
Pricing Strategy
2
Reimbursement Consulting
39
Payer Relationship Management
16
Launch Sequencing
1
Pharmacovigilance *
Safety Systems
90
Safety Database Hosting
0
Signal Detection
0
Case Processing
1
Safety Data Intake & Triage
33
Aggregate Reporting
0
Show More (3)
Safety Data Analytics
37
Safety Signal Evaluation
26
Literature Searching
1
Show Less (3)
Risk Management
29
Safety Communications
5
Risk Evaluation & Minimization
20
Risk Management Evaluation
11
Finance & Investment *
Financial Services
8
Investment Performance Analytics
2
Revenue Forecasting & Planning
2
Billing & Reporting Operations
3
Internal Audit Support
1
Investment Banking
7
Buy & Sell Side Advisory
3
Capital Raising & Financing
5
Investor Relations
0
Quality & Mfg *
Facilities & Equipment
15
Equipment Maintenance
1
Facility Maintenance Programs
8
Facility Security Management
5
Deviation Investigations
0
Calibration & PM Programs
2
Testing & Release
18
Stability Program Testing
5
Batch Release Testing
2
Raw Material Testing
12
Quality Management
86
Deviation Investigation
10
Corrective Action Verification
49
Quality Process Governance
31
Production & Supply Chain
57
Storage & Distribution
26
Labeling & Packaging
18
Clinical & Commercial Production
28
Clinical Research *
Real World Data Research
44
Data Standardization & Curation
15
Late Phase Data Curation
15
Analytics Methods Development
14
Lifecycle Evidence Generation
14
Real World Evidence
8
Show More (2)
Evidence Prioritization
9
Observational Research
22
Show Less (2)
Study Operations & Management
133
Site Contracting & Payments
3
Study Tracking & Analytics
84
Site Relationship Management
4
Trial Implementation
1
Site Identification & Activation
16
Show More (1)
Patient Recruitment
34
Show Less (1)
Clinical Reporting
17
Clinical Study Report Writing
11
Abstract & Poster Development
5
Manuscript Development
3
Product Development
261
Clinical Research Network Development
4
Analytical Methods Development
3
Clinical Research
156
Clinical Trial Material Supply
7
Clinical Trials
110
Show More (4)
Drug Product Manufacturing
6
Submissions Management
9
Formulation Development
4
Document Management
16
Show Less (4)
Trial Design & Planning
85
Protocol Feasibility Planning
12
Statistical Analysis Planning
8
Enrollment Analytics
4
Patient Recruitment Planning
52
Data Management Planning
10
Show More (1)
Software
5
Show Less (1)
Technology & Operations *
Automation & Efficiency
20
Lab Automation Systems
1
Clinical Data Automation
15
Supply Chain Automation
5
Data & Analytics
150
Data Curation
27
Artificial Intelligence
17
Data Visualization
55
Advanced Analytics
89
Early Development
49
Clinical Trial Management Systems
46
Clinical Supply Chain Automation
3
Digital Health Solutions
101
5G Infrastructure
4
mHealth Applications
20
Patient Portals
30
Blockchain Applications
1
Telemedicine Platforms
28
Show More (1)
Wearables & Sensors
32
Show Less (1)
Operations
83
Medical Writing
7
Management Consulting
8
Other
4
Human Resources & Talent Acquisition
27
Public Relations
2
Show More (7)
Communications
8
Operations Management
1
Marketing
24
Product/Service
2
Communications & Corporate Affairs
4
Content Creation & Development
13
Medical Information Services
9
Show Less (7)
Informatics Infrastructure
83
Data Storage Platforms
8
Data Security Solutions
23
Cloud Computing Systems
57
2
3
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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.
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