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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Medical Affairs *
Scientific Communications Development
15
Medical Writing
4
Payer Advisory Board Strategy
10
Market Access Advisory Panels
2
Strategic Stakeholder Engagement
72
KOL Relationship Management
16
Advisory Board Strategy
41
Stakeholder Influence Mapping
27
Defining the Value of Medical Affairs
2
Defining the Value of Medical Affairs
2
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
35
Publication Planning
8
Medical and Scientific Communications
1
Scientific Platform Planning
24
Competitive Publications Analysis
4
Regulatory *
Labeling & Promotions
6
Labeling Strategy Development
3
Core Data Sheet Management
3
Maintenance & Renewals
10
Variations & Supplements
3
Post-Approval Safety Reporting
4
Promotional Material Compliance
5
Compliance
187
Regulatory Compliance
106
Dossier & Application Development
29
Pre-Submission Advisory Meetings
2
eCTD Publishing & Validation
14
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57
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Clinical Disclosure
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46
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16
Campaign Concept Testing
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Multi-Channel Campaign Launch
6
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7
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1
Legislative Monitoring
1
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1
Global Market Access
54
Payer Evidence Generation
3
Pricing Strategy
2
Reimbursement Consulting
37
Payer Relationship Management
16
Launch Sequencing
1
Pharmacovigilance *
Safety Systems
86
Safety Database Hosting
0
Signal Detection
0
Case Processing
1
Safety Data Intake & Triage
32
Aggregate Reporting
0
Show More (3)
Safety Data Analytics
36
Safety Signal Evaluation
23
Literature Searching
1
Show Less (3)
Risk Management
25
Safety Communications
4
Risk Evaluation & Minimization
18
Risk Management Evaluation
7
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Financial Services
8
Investment Performance Analytics
2
Revenue Forecasting & Planning
2
Billing & Reporting Operations
3
Internal Audit Support
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Equipment Maintenance
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8
Facility Security Management
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Calibration & PM Programs
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Testing & Release
17
Stability Program Testing
4
Batch Release Testing
2
Raw Material Testing
12
Quality Management
83
Deviation Investigation
10
Corrective Action Verification
49
Quality Process Governance
28
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55
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23
Labeling & Packaging
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Clinical & Commercial Production
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42
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Late Phase Data Curation
8
Analytics Methods Development
14
Lifecycle Evidence Generation
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Real World Evidence
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Show More (2)
Evidence Prioritization
2
Observational Research
14
Show Less (2)
Study Operations & Management
127
Site Contracting & Payments
2
Study Tracking & Analytics
81
Site Relationship Management
4
Trial Implementation
1
Site Identification & Activation
14
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Patient Recruitment
31
Show Less (1)
Clinical Reporting
16
Clinical Study Report Writing
10
Abstract & Poster Development
5
Manuscript Development
1
Product Development
254
Clinical Research Network Development
2
Analytical Methods Development
3
Clinical Research
156
Clinical Trial Material Supply
3
Clinical Trials
99
Show More (4)
Drug Product Manufacturing
3
Submissions Management
3
Formulation Development
1
Document Management
9
Show Less (4)
Trial Design & Planning
76
Protocol Feasibility Planning
8
Statistical Analysis Planning
6
Enrollment Analytics
4
Patient Recruitment Planning
47
Data Management Planning
9
Show More (1)
Software
4
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20
Lab Automation Systems
1
Clinical Data Automation
15
Supply Chain Automation
5
Data & Analytics
152
Data Curation
21
Artificial Intelligence
14
Data Visualization
48
Advanced Analytics
91
Early Development
47
Clinical Trial Management Systems
45
Clinical Supply Chain Automation
2
Digital Health Solutions
96
Managed Services
1
Global Connectivity
1
5G Infrastructure
4
mHealth Applications
17
Patient Portals
26
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1
Telemedicine Platforms
25
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Medical Writing
3
Management Consulting
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3
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25
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8
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0
Marketing
22
Product/Service
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Communications & Corporate Affairs
4
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10
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81
Data Storage Platforms
8
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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
15
Medical Writing
4
Payer Advisory Board Strategy
10
Market Access Advisory Panels
2
Strategic Stakeholder Engagement
72
KOL Relationship Management
16
Advisory Board Strategy
41
Stakeholder Influence Mapping
27
Defining the Value of Medical Affairs
2
Defining the Value of Medical Affairs
2
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
35
Publication Planning
8
Medical and Scientific Communications
1
Scientific Platform Planning
24
Competitive Publications Analysis
4
Regulatory *
Labeling & Promotions
6
Labeling Strategy Development
3
Core Data Sheet Management
3
Maintenance & Renewals
10
Variations & Supplements
3
Post-Approval Safety Reporting
4
Promotional Material Compliance
5
Compliance
187
Regulatory Compliance
106
Dossier & Application Development
29
Pre-Submission Advisory Meetings
2
eCTD Publishing & Validation
14
Agency Meeting Support
57
Show More (1)
Structured Content Authoring
3
Show Less (1)
Transparency & Disclosure
6
Clinical Disclosure
2
Clinical Transparency
5
Commercialization *
Customer Engagement
46
Patient Engagement
6
Patient Facing Solution Design
15
Patient Journey Analysis
7
Omnichannel Optimization
12
Strategic Account Management
1
Show More (1)
Retention Program Effectiveness
9
Show Less (1)
Brand Planning & Activation
16
Campaign Concept Testing
3
Multi-Channel Campaign Launch
6
Brand Vision & Positioning
7
Market Access & Policy *
Government Policy
1
Legislative Monitoring
1
Advocacy Management
1
Global Market Access
54
Payer Evidence Generation
3
Pricing Strategy
2
Reimbursement Consulting
37
Payer Relationship Management
16
Launch Sequencing
1
Pharmacovigilance *
Safety Systems
86
Safety Database Hosting
0
Signal Detection
0
Case Processing
1
Safety Data Intake & Triage
32
Aggregate Reporting
0
Show More (3)
Safety Data Analytics
36
Safety Signal Evaluation
23
Literature Searching
1
Show Less (3)
Risk Management
25
Safety Communications
4
Risk Evaluation & Minimization
18
Risk Management Evaluation
7
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
14
Equipment Maintenance
1
Facility Maintenance Programs
8
Facility Security Management
5
Deviation Investigations
0
Calibration & PM Programs
1
Testing & Release
17
Stability Program Testing
4
Batch Release Testing
2
Raw Material Testing
12
Quality Management
83
Deviation Investigation
10
Corrective Action Verification
49
Quality Process Governance
28
Production & Supply Chain
55
Storage & Distribution
23
Labeling & Packaging
18
Clinical & Commercial Production
28
Clinical Research *
Real World Data Research
42
Data Standardization & Curation
10
Late Phase Data Curation
8
Analytics Methods Development
14
Lifecycle Evidence Generation
5
Real World Evidence
0
Show More (2)
Evidence Prioritization
2
Observational Research
14
Show Less (2)
Study Operations & Management
127
Site Contracting & Payments
2
Study Tracking & Analytics
81
Site Relationship Management
4
Trial Implementation
1
Site Identification & Activation
14
Show More (1)
Patient Recruitment
31
Show Less (1)
Clinical Reporting
16
Clinical Study Report Writing
10
Abstract & Poster Development
5
Manuscript Development
1
Product Development
254
Clinical Research Network Development
2
Analytical Methods Development
3
Clinical Research
156
Clinical Trial Material Supply
3
Clinical Trials
99
Show More (4)
Drug Product Manufacturing
3
Submissions Management
3
Formulation Development
1
Document Management
9
Show Less (4)
Trial Design & Planning
76
Protocol Feasibility Planning
8
Statistical Analysis Planning
6
Enrollment Analytics
4
Patient Recruitment Planning
47
Data Management Planning
9
Show More (1)
Software
4
Show Less (1)
Technology & Operations *
Automation & Efficiency
20
Lab Automation Systems
1
Clinical Data Automation
15
Supply Chain Automation
5
Data & Analytics
152
Data Curation
21
Artificial Intelligence
14
Data Visualization
48
Advanced Analytics
91
Early Development
47
Clinical Trial Management Systems
45
Clinical Supply Chain Automation
2
Digital Health Solutions
96
Managed Services
1
Global Connectivity
1
5G Infrastructure
4
mHealth Applications
17
Patient Portals
26
Show More (3)
Blockchain Applications
1
Telemedicine Platforms
25
Wearables & Sensors
33
Show Less (3)
Operations
76
Medical Writing
3
Management Consulting
6
Other
3
Human Resources & Talent Acquisition
25
Public Relations
1
Show More (7)
Communications
8
Operations Management
0
Marketing
22
Product/Service
1
Communications & Corporate Affairs
4
Content Creation & Development
10
Medical Information Services
3
Show Less (7)
Informatics Infrastructure
81
Data Storage Platforms
8
Data Security Solutions
21
Cloud Computing Systems
55
2
3
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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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