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150

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105

Show More (4)

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Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

252

Analytical Methods Development

Clinical Research

150

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

105

Show More (4)

Document Management

Drug Product Manufacturing

Formulation Development

Submissions Management

Show Less (4)

Real World Data Research

Analytics Methods Development

Data Standardization & Curation

Evidence Prioritization

Late Phase Data Curation

Lifecycle Evidence Generation

Show More (2)

Observational Research

Real World Evidence

Show Less (2)

Study Operations & Management

121

Patient Recruitment

Site Contracting & Payments

Site Identification & Activation

Site Relationship Management

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Show More (1)

Trial Implementation

Show Less (1)

Trial Design & Planning

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

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Brand Vision & Positioning

Campaign Concept Testing

Multi-Channel Campaign Launch

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Global Market Access

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Government Policy

Advocacy Management

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Defining the Value of Medical Affairs

Evidence Generation

103

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Medical Writing

Publication Planning

Scientific Platform Planning

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Advisory Board Strategy

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Risk Management Evaluation

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Show Less (3)

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Labeling & Packaging

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Corrective Action Verification

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Testing & Release

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169

Agency Meeting Support

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eCTD Publishing & Validation

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Regulatory Compliance

102

Show More (1)

Structured Content Authoring

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Labeling & Promotions

Core Data Sheet Management

Labeling Strategy Development

Maintenance & Renewals

Post-Approval Safety Reporting

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Clinical Transparency

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Clinical Data Automation

Lab Automation Systems

Supply Chain Automation

Data & Analytics

126

Advanced Analytics

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Digital Health Solutions

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About

Product Development

Clinical Research

Evidence Generation

Health Economics Modeling

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Headquarters

4820 Emperor Boulevard, Durham, NC 27703-8426, USA

Thera-Business Consulting

Accelerating Regulatory Approval with Evidence-Based Solutions

Thera-Business is a leading provider of regulatory and scientific services with over 25 years of experience supporting medical device and pharmaceutical companies through the product development and approval process. Our team of experts includes medical writers, statisticians, systematic reviewers, and regulatory consultants who work collaboratively to generate high-quality regulatory documents, literature reviews, meta-analyses, post-market surveillance reports, and more to ensure our clients achieve regulatory compliance and accelerate time to market.

With a rigorous scientific approach, innovative solutions, and unmatched expertise, we enable our clients to build a strong evidence base to demonstrate the safety and efficacy of their products. Let us guide you through clinical evaluations, generate real-world evidence, and craft persuasive regulatory submissions to achieve your goals.

Accelerating Regulatory Approval with Evidence-Based Solutions

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Thera-Business Consulting

Thera-Business Consulting

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Thera-Business Consulting

Accelerating Regulatory Approval with Evidence-Based Solutions

Accelerating Regulatory Approval with Evidence-Based Solutions

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