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Medical Affairs *

Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

Advisory Board Strategy

Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

104

Clinical Trial Concepts

Internal Medical Education

Health Economics Modeling

Patient Journey Mapping

Research Gap Analysis

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Medical and Scientific Communications

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Post-Approval Safety Reporting

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186

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117

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133

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110

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Medical Affairs *

Scientific Communications Development

Medical Writing

Payer Advisory Board Strategy

Market Access Advisory Panels

Strategic Stakeholder Engagement

KOL Relationship Management

Advisory Board Strategy

Stakeholder Influence Mapping

Defining the Value of Medical Affairs

Evidence Generation

104

Clinical Trial Concepts

Internal Medical Education

Health Economics Modeling

Patient Journey Mapping

Research Gap Analysis

Strategic Communications Planning

Publication Planning

Medical and Scientific Communications

Scientific Platform Planning

Competitive Publications Analysis

Regulatory *

Labeling & Promotions

Labeling Strategy Development

Core Data Sheet Management

Maintenance & Renewals

Variations & Supplements

Post-Approval Safety Reporting

Promotional Material Compliance

Compliance

186

Regulatory Compliance

117

Dossier & Application Development

Pre-Submission Advisory Meetings

eCTD Publishing & Validation

Agency Meeting Support

Show More (1)

Structured Content Authoring

Show Less (1)

Transparency & Disclosure

Clinical Disclosure

Clinical Transparency

Commercialization *

Customer Engagement

Patient Engagement

Patient Facing Solution Design

Patient Journey Analysis

Omnichannel Optimization

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Show More (1)

Retention Program Effectiveness

Show Less (1)

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Multi-Channel Campaign Launch

Brand Vision & Positioning

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Government Policy

Legislative Monitoring

Advocacy Management

Global Market Access

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Reimbursement Consulting

Payer Relationship Management

Launch Sequencing

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Safety Systems

Safety Database Hosting

Signal Detection

Case Processing

Safety Data Intake & Triage

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Literature Searching

Show Less (3)

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Buy & Sell Side Advisory

Capital Raising & Financing

Investor Relations

Quality & Mfg *

Facilities & Equipment

Equipment Maintenance

Facility Maintenance Programs

Facility Security Management

Deviation Investigations

Calibration & PM Programs

Testing & Release

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Batch Release Testing

Raw Material Testing

Quality Management

Deviation Investigation

Corrective Action Verification

Quality Process Governance

Production & Supply Chain

Storage & Distribution

Labeling & Packaging

Clinical & Commercial Production

Clinical Research *

Real World Data Research

Data Standardization & Curation

Late Phase Data Curation

Analytics Methods Development

Lifecycle Evidence Generation

Real World Evidence

Show More (2)

Evidence Prioritization

Observational Research

Show Less (2)

Study Operations & Management

133

Site Contracting & Payments

Study Tracking & Analytics

Site Relationship Management

Trial Implementation

Site Identification & Activation

Show More (1)

Patient Recruitment

Show Less (1)

Clinical Reporting

Clinical Study Report Writing

Abstract & Poster Development

Manuscript Development

Product Development

262

Clinical Research Network Development

Analytical Methods Development

Clinical Research

156

Clinical Trial Material Supply

Clinical Trials

110

Show More (4)

Drug Product Manufacturing

Submissions Management

Formulation Development

Document Management

Show Less (4)

Trial Design & Planning

Protocol Feasibility Planning

Statistical Analysis Planning

Enrollment Analytics

Patient Recruitment Planning

Data Management Planning

Show More (1)

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Show Less (1)

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Automation & Efficiency

Lab Automation Systems

Clinical Data Automation

Supply Chain Automation

Data & Analytics

149

Data Curation

Artificial Intelligence

Data Visualization

Advanced Analytics

Early Development

Clinical Trial Management Systems

Clinical Supply Chain Automation

Digital Health Solutions

101

5G Infrastructure

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Patient Portals

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Telemedicine Platforms

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Medical Writing

Management Consulting

Other

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Show More (7)

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About

Evidence Generation

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6100 West Plano Parkway, Plano, TX 75024, USA

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Gens & Associates, Inc.

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Achieving Excellence Through Insightful Benchmarking

Gens Associates is a boutique life science advisory firm specializing in performance improvement, industry benchmarking, and organizational transition. Our primary focus is the regulatory domain and how it connects with other functions.

We leverage our extensive proprietary benchmarking data and deep expertise to help companies transform their regulatory operations. Our collaborative approach enables rapid strategy development and pragmatic solutions tailored to each client's needs. We partner with organizations of all sizes to drive excellence.

Achieving Excellence Through Insightful Benchmarking

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6100 West Plano Parkway, Plano, TX 75024, USA

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