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Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

261

Analytical Methods Development

Clinical Research

158

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

110

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

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132

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Clinical Research *

Clinical Reporting

Abstract & Poster Development

Clinical Study Report Writing

Manuscript Development

Product Development

261

Analytical Methods Development

Clinical Research

158

Clinical Research Network Development

Clinical Trial Material Supply

Clinical Trials

110

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

132

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

Data Management Planning

Enrollment Analytics

Patient Recruitment Planning

Protocol Feasibility Planning

Software

Show More (1)

Statistical Analysis Planning

Show Less (1)

Commercialization *

Brand Planning & Activation

Brand Vision & Positioning

Campaign Concept Testing

Multi-Channel Campaign Launch

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Show Less (1)

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Global Market Access

Launch Sequencing

Payer Evidence Generation

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Pricing Strategy

Reimbursement Consulting

Government Policy

Advocacy Management

Legislative Monitoring

Medical Affairs *

Defining the Value of Medical Affairs

Evidence Generation

102

Clinical Trial Concepts

Health Economics Modeling

Internal Medical Education

Patient Journey Mapping

Research Gap Analysis

Scientific Communications Development

Market Access Advisory Panels

Medical Writing

Payer Advisory Board Strategy

Strategic Communications Planning

Competitive Publications Analysis

Medical and Scientific Communications

Publication Planning

Scientific Platform Planning

Strategic Stakeholder Engagement

Advisory Board Strategy

KOL Relationship Management

Stakeholder Influence Mapping

Pharmacovigilance *

Risk Management

Risk Evaluation & Minimization

Risk Management Evaluation

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Safety Systems

Aggregate Reporting

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Literature Searching

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Signal Detection

Show Less (3)

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Deviation Investigations

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Storage & Distribution

Quality Management

Corrective Action Verification

Deviation Investigation

Quality Process Governance

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Batch Release Testing

Raw Material Testing

Stability Program Testing

Regulatory *

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186

Agency Meeting Support

Dossier & Application Development

eCTD Publishing & Validation

Pre-Submission Advisory Meetings

Regulatory Compliance

118

Show More (1)

Structured Content Authoring

Show Less (1)

Labeling & Promotions

Core Data Sheet Management

Labeling Strategy Development

Maintenance & Renewals

Post-Approval Safety Reporting

Promotional Material Compliance

Variations & Supplements

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Technology & Operations *

Automation & Efficiency

Clinical Data Automation

Lab Automation Systems

Supply Chain Automation

Data & Analytics

148

Advanced Analytics

Artificial Intelligence

Data Curation

Data Visualization

Digital Health Solutions

101

5G Infrastructure

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mHealth Applications

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Early Development

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About

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Clinical Research

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940 West Valley Rd., Suite 1302, Wayne, PA 19087, USA

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Global Regulatory and Submission Experts Offering Over 30 Years of Insight

For over

decades, this international consulting firm has provided strategic guidance and deliverables to support clients through the entire drug development process - from preclinical to clinical trials, data analysis, regulatory submissions and more. With expertise spanning numerous therapeutic areas, they offer comprehensive contract research and submission services including CDISC conversion, eCTD publishing and US agent representation. Their consulting integrates evaluations across nonclinical, clinical and CMC disciplines to identify development gaps and regulatory strategies. Services range from trial design, pharmacology reviews, dataset coding, IND/NDA authoring, FDA briefing books, due diligence and beyond.

Global Regulatory and Submission Experts Offering Over 30 Years of Insight

For over

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Global Regulatory and Submission Experts Offering Over 30 Years of Insight

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