Informed Consent Form of an IND Submission with AgileWriter™
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Synterex, Inc.
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Informed Consent Form of an IND Submission with AgileWriter™
Synterex, Inc.
The agile clinical & regulatory consulti...Products
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Clinical Study Report Writing
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Defining the Value of Medical Affairs
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103
Clinical Trial Concepts
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Health Economics Modeling
60
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2
Clinical Trial Management Systems
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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 *
Clinical Reporting
16
Abstract & Poster Development
5
Clinical Study Report Writing
10
Manuscript Development
1
Product Development
257
Analytical Methods Development
3
Clinical Research
159
Clinical Research Network Development
2
Clinical Trial Material Supply
3
Clinical Trials
102
Show More (4)
Document Management
9
Drug Product Manufacturing
3
Formulation Development
1
Submissions Management
3
Show Less (4)
Real World Data Research
42
Analytics Methods Development
14
Data Standardization & Curation
10
Evidence Prioritization
2
Late Phase Data Curation
8
Lifecycle Evidence Generation
5
Show More (2)
Observational Research
14
Real World Evidence
0
Show Less (2)
Study Operations & Management
127
Patient Recruitment
31
Site Contracting & Payments
2
Site Identification & Activation
14
Site Relationship Management
4
Study Tracking & Analytics
81
Show More (1)
Trial Implementation
1
Show Less (1)
Trial Design & Planning
76
Data Management Planning
9
Enrollment Analytics
4
Patient Recruitment Planning
47
Protocol Feasibility Planning
8
Software
4
Show More (1)
Statistical Analysis Planning
6
Show Less (1)
Commercialization *
Brand Planning & Activation
16
Brand Vision & Positioning
7
Campaign Concept Testing
3
Multi-Channel Campaign Launch
6
Customer Engagement
46
Omnichannel Optimization
12
Patient Engagement
6
Patient Facing Solution Design
15
Patient Journey Analysis
7
Retention Program Effectiveness
9
Show More (1)
Strategic Account Management
1
Show Less (1)
Finance & Investment *
Financial Services
8
Billing & Reporting Operations
3
Internal Audit Support
1
Investment Performance Analytics
2
Revenue Forecasting & Planning
2
Investment Banking
7
Buy & Sell Side Advisory
3
Capital Raising & Financing
5
Investor Relations
0
Market Access & Policy *
Global Market Access
54
Launch Sequencing
1
Payer Evidence Generation
3
Payer Relationship Management
16
Pricing Strategy
2
Reimbursement Consulting
37
Government Policy
1
Advocacy Management
1
Legislative Monitoring
1
Medical Affairs *
Defining the Value of Medical Affairs
2
Defining the Value of Medical Affairs
2
Evidence Generation
103
Clinical Trial Concepts
15
Health Economics Modeling
60
Internal Medical Education
22
Patient Journey Mapping
3
Research Gap Analysis
6
Scientific Communications Development
15
Market Access Advisory Panels
2
Medical Writing
4
Payer Advisory Board Strategy
10
Strategic Communications Planning
35
Competitive Publications Analysis
4
Medical and Scientific Communications
1
Publication Planning
8
Scientific Platform Planning
24
Strategic Stakeholder Engagement
72
Advisory Board Strategy
41
KOL Relationship Management
16
Stakeholder Influence Mapping
27
Pharmacovigilance *
Risk Management
25
Risk Evaluation & Minimization
18
Risk Management Evaluation
7
Safety Communications
4
Safety Systems
86
Aggregate Reporting
0
Case Processing
1
Literature Searching
1
Safety Data Analytics
36
Safety Data Intake & Triage
32
Show More (3)
Safety Database Hosting
0
Safety Signal Evaluation
23
Signal Detection
0
Show Less (3)
Quality & Mfg *
Facilities & Equipment
14
Calibration & PM Programs
1
Deviation Investigations
0
Equipment Maintenance
1
Facility Maintenance Programs
8
Facility Security Management
5
Production & Supply Chain
55
Clinical & Commercial Production
28
Labeling & Packaging
18
Storage & Distribution
23
Quality Management
83
Corrective Action Verification
49
Deviation Investigation
10
Quality Process Governance
28
Testing & Release
17
Batch Release Testing
2
Raw Material Testing
12
Stability Program Testing
4
Regulatory *
Compliance
187
Agency Meeting Support
57
Dossier & Application Development
29
eCTD Publishing & Validation
14
Pre-Submission Advisory Meetings
2
Regulatory Compliance
106
Show More (1)
Structured Content Authoring
3
Show Less (1)
Labeling & Promotions
7
Core Data Sheet Management
3
Labeling Strategy Development
4
Maintenance & Renewals
10
Post-Approval Safety Reporting
4
Promotional Material Compliance
5
Variations & Supplements
3
Transparency & Disclosure
7
Clinical Disclosure
2
Clinical Transparency
6
Technology & Operations *
Automation & Efficiency
20
Clinical Data Automation
15
Lab Automation Systems
1
Supply Chain Automation
5
Data & Analytics
152
Advanced Analytics
91
Artificial Intelligence
14
Data Curation
21
Data Visualization
48
Digital Health Solutions
96
5G Infrastructure
4
Blockchain Applications
1
Global Connectivity
1
Managed Services
1
mHealth Applications
17
Show More (3)
Patient Portals
26
Telemedicine Platforms
25
Wearables & Sensors
33
Show Less (3)
Early Development
47
Clinical Supply Chain Automation
2
Clinical Trial Management Systems
45
Informatics Infrastructure
81
Cloud Computing Systems
55
Data Security Solutions
21
Data Storage Platforms
8
Operations
76
Communications
8
Communications & Corporate Affairs
4
Content Creation & Development
10
Human Resources & Talent Acquisition
25
Management Consulting
6
Show More (7)
Marketing
22
Medical Information Services
3
Medical Writing
3
Operations Management
0
Other
3
Product/Service
1
Public Relations
1
Show Less (7)
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A small biotech needed an informed consent form (ICF) for an IND submission, with limited lead time following agency feedback. The challenge was compounded by a lack of prior materials and an untested template.
Synterex’s Solution:
AgileWriter™ was pretrained using draft sources and updated incrementally as new protocol information became available. The model’s output was so robust it was also leveraged to produce a pregnant partner ICF for the same study.
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