Rapid Application Integration and 21 CFR Part 11 Compliant Hosting
Posted by Keith P.Court Square Group, Inc.
103 days ago
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Court Square Group, Inc.
Court Square Group, Inc.
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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.
Clinical Research *
5
Clinical Reporting
3
Abstract & Poster Development
Clinical Study Report Writing
Manuscript Development
Product Development
9
Analytical Methods Development
Clinical Research
Clinical Research Network Development
Clinical Trial Material Supply
Clinical Trials
Show More (4)
Document Management
Drug Product Manufacturing
Formulation Development
Submissions Management
Show Less (4)
Real World Data Research
6
Analytics Methods Development
Data Standardization & Curation
Evidence Prioritization
Late Phase Data Curation
Lifecycle Evidence Generation
Show More (1)
Observational Research
Show Less (1)
Study Operations & Management
6
Patient Recruitment
Site Contracting & Payments
Site Identification & Activation
Site Relationship Management
Study Tracking & Analytics
Show More (1)
Trial Implementation
Show Less (1)
Trial Design & Planning
6
Data Management Planning
Enrollment Analytics
Patient Recruitment Planning
Protocol Feasibility Planning
Software
Show More (1)
Statistical Analysis Planning
Show Less (1)
Commercialization *
2
Brand Planning & Activation
3
Brand Vision & Positioning
Campaign Concept Testing
Multi-Channel Campaign Launch
Customer Engagement
6
Omnichannel Optimization
Patient Engagement
Patient Facing Solution Design
Patient Journey Analysis
Retention Program Effectiveness
Show More (1)
Strategic Account Management
Show Less (1)
Finance & Investment *
2
Financial Services
4
Billing & Reporting Operations
Internal Audit Support
Investment Performance Analytics
Revenue Forecasting & Planning
Investment Banking
3
Buy & Sell Side Advisory
Capital Raising & Financing
Investor Relations
Market Access & Policy *
2
Global Market Access
5
Launch Sequencing
Payer Evidence Generation
Payer Relationship Management
Pricing Strategy
Reimbursement Consulting
Government Policy
2
Advocacy Management
Legislative Monitoring
Medical Affairs *
5
Defining the Value of Medical Affairs
1
Defining the Value of Medical Affairs
Evidence Generation
5
Clinical Trial Concepts
Health Economics Modeling
Internal Medical Education
Patient Journey Mapping
Research Gap Analysis
Scientific Communications Development
2
Market Access Advisory Panels
Payer Advisory Board Strategy
Strategic Communications Planning
3
Competitive Publications Analysis
Publication Planning
Scientific Platform Planning
Strategic Stakeholder Engagement
3
Advisory Board Strategy
KOL Relationship Management
Stakeholder Influence Mapping
Pharmacovigilance *
2
Risk Management
3
Risk Evaluation & Minimization
Risk Management Evaluation
Safety Communications
Safety Systems
3
Safety Data Analytics
Safety Data Intake & Triage
Safety Signal Evaluation
Quality & Mfg *
4
Facilities & Equipment
5
Calibration & PM Programs
Deviation Investigations
Equipment Maintenance
Facility Maintenance Programs
Facility Security Management
Production & Supply Chain
3
Clinical & Commercial Production
Labeling & Packaging
Storage & Distribution
Quality Management
3
Corrective Action Verification
Deviation Investigation
Quality Process Governance
Testing & Release
3
Batch Release Testing
Raw Material Testing
Stability Program Testing
Regulatory *
4
Compliance
5
Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
2
Core Data Sheet Management
Labeling Strategy Development
Maintenance & Renewals
3
Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
Transparency & Disclosure
2
Clinical Disclosure
Clinical Transparency
Technology & Operations *
6
Automation & Efficiency
3
Clinical Data Automation
Lab Automation Systems
Supply Chain Automation
Data & Analytics
4
Advanced Analytics
Artificial Intelligence
Data Curation
Data Visualization
Digital Health Solutions
6
5G Infrastructure
Blockchain Applications
mHealth Applications
Patient Portals
Telemedicine Platforms
Show More (1)
Wearables & Sensors
Show Less (1)
Early Development
2
Clinical Supply Chain Automation
Clinical Trial Management Systems
Informatics Infrastructure
3
Cloud Computing Systems
Data Security Solutions
Data Storage Platforms
Operations
12
Communications
Communications & Corporate Affairs
Content Creation & Development
Human Resources & Talent Acquisition
Management Consulting
Show More (7)
Marketing
Medical Information Services
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Show Less (7)
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Court Square Group, Inc.
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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