Global Value Dossier (GVD): A Strategic Tool for Market Access and Global Health Impact

In an era where health systems demand evidence of value before granting access or reimbursement, the Global Value Dossier (GVD) has emerged as a pivotal document for biopharmaceutical and medical device companies. It is more than just a scientific record—it’s a strategic blueprint that unites clinical, economic, and humanistic value into one narrative to support global market access.

At CliEvi, we specialize in end-to-end support for GVD development—from evidence gathering, writing, analysis, and review, to publication in high-impact journals. Whether for a novel therapy, a biologic, or a combination product, our GVD services are designed to maximize your product's value demonstration across international markets.

What is a Global Value Dossier (GVD)?

A Global Value Dossier is a comprehensive, centralized document that contains all core clinical, economic, and epidemiological evidence about a product. This master document is adapted and reused across countries, regions, and payer systems to support Health Technology Assessments (HTAs), reimbursement applications, pricing negotiations, and other regulatory submissions.

GVDs typically include:

• Disease overview and burden of illness
• Unmet clinical needs
• Product profile and mechanism of action
• Summary of clinical efficacy and safety
• Real-world evidence and observational data
• Cost-effectiveness and budget impact models
• Patient-reported outcomes (PROs)
• Health economic evaluations
• Competitive landscape
• Scientific references and model documentation

Why is a GVD Beneficial?

The GVD acts as a gold standard evidence repository with several critical functions:

Consistency Across Markets

It ensures a consistent message regarding product value is communicated across all global markets—critical for brand and regulatory success.

Faster Market Access

A well-prepared GVD can reduce time-to-market by enabling swift local adaptations for submission to HTA bodies (e.g., NICE in the UK, HAS in France, PBAC in Australia, etc.).

Scientific Credibility

Including systematic reviews, meta-analyses, and economic modeling improves your dossier’s strength during pricing and reimbursement evaluations.

Support for Local Value Dossiers (LVDs)

GVDs serve as source documents to create LVDs tailored to country-specific needs, such as Japan (MHLW), Italy (AIFA), Singapore (MOH), or the US (ICER).

Where Are GVDs Published or Submitted?

Though not often published as complete documents, GVD components are widely disseminated through:

• HTA agency portals (NICE, CADTH, ZIN, IQWiG, etc.)
• ISPOR presentations and posters
• Peer-reviewed journals for economic modeling, systematic reviews, and clinical comparisons
• Real-world evidence publications
• Internal strategic meetings and market access teams

CliEvi’s GVD Development Services

At CliEvi, we support biotech, pharmaceutical, diagnostics, and medical device companies at every stage of GVD development.

Evidence-Based Writing

• Systematic literature reviews (SLRs)
• Narrative reviews and burden-of-disease analysis
• Incorporation of PROs and quality-of-life metrics
• Inclusion of GRADE, PRISMA, CHEERS, and AMSTAR standards

Advanced Data Analytics

• Epidemiological modeling
• HEOR modeling (e.g., cost-effectiveness, QALY, DALY, ICER, budget impact)
• Real-world data integration (TrinetX, NHANES, GHDx, NFHS, WHO)

Scientific Content Development

• Custom visualizations and infographics
• Competitive landscape assessment
• Unmet need identification
• Summary of product value by stakeholder type (payer, clinician, patient)

Local Adaptation Support

• Conversion of GVDs into LVDs tailored to:
• UK, Germany, Spain, Italy, France, Australia, Japan, Singapore, USA, Canada, and emerging markets
• Adherence to local HTA agency guidelines and formatting

Evidence Sources We Use

Our team uses validated and authoritative sources such as:

• PubMed/Medline
• EMBASE
• GHDx (Global Health Data Exchange)
• TrinetX & other RWD platforms
• WHO reports
• Global Burden of Disease (GBD) studies
• National health datasets (NFHS, CNNS, etc.)

Publishing Support for High-Impact Journals

To maximize visibility and influence:

1. We identify high-impact journals for publishing GVD components (e.g., Value in Health, Pharmacoeconomics, BMJ Open, Journal of Comparative Effectiveness Research)
2. Full manuscript writing, statistical analysis, submission handling, and revision support included
3. We also support conference abstracts, poster preparation, and slide decks for ISPOR, ISPE, DIA, and more

Our GVD Expertise at CliEvi

Multi-disciplinary Experts

Medical writers, pharmacoeconomists, HTA specialists, statisticians, and data scientists collaborate for a unified dossier.

Timely Delivery

We follow Gantt charts, agile workflows, and internal QC cycles for on-time, error-free submission-ready dossiers.

Strategic Focus

We not only write dossiers—we build strategy around evidence gaps, regulatory needs, and HTA alignment.

Proven Track Record

Delivered over 20+ global dossiers
Published over 100+ associated papers in indexed journals
Supported clients across oncology, rare diseases, metabolic disorders, neurology, and more

How We Work with You

We engage in three flexible models:

Full-service model: End-to-end dossier development
Collaborative model: Work with your team to integrate and format existing evidence
Module-specific model: Literature review, economic modeling, or real-world evidence generation only

Let’s Maximize Your Product’s Value

A well-crafted GVD not only opens doors to markets—it ensures you walk through them as a trusted, evidence-backed partner in global health. At CliEvi, our goal is to craft scientifically sound, access-focused documents that truly communicate the clinical and economic value of innovation.

Reach out to us today to begin building your Global Value Dossier with expert guidance from start to submission.

 

Systematic Literature Review Services: Comprehensive, Evidence-Based, and Publication-Ready

Introduction

Systematic Literature Reviews (SLRs) are the gold standard for synthesizing scientific evidence to inform research, regulatory decisions, clinical practice, and health policy. Unlike traditional narrative reviews, SLRs follow a structured, transparent, and reproducible methodology to minimize bias and maximize the reliability of findings. At CliEvi, we offer end-to-end SLR services that include protocol development, literature search strategy, screening, data extraction, quality assessment, synthesis, and publication support for high-impact factor journals.

Our SLR services are tailored to support pharmaceutical, biotechnology, diagnostics, medical device companies, CROs, regulatory bodies, and academic institutions. Whether you require a review of clinical interventions, public health strategies, diagnostic tools, or real-world data, CliEvi ensures your review is thorough, compliant, and scientifically robust.

What is a Systematic Literature Review (SLR)?

A Systematic Literature Review is a comprehensive, methodologically rigorous synthesis of existing research on a clearly formulated research question. It uses predefined inclusion/exclusion criteria, structured search strategies, and transparent processes for data selection and synthesis.

Key Components:

Clearly defined objectives and PICO framework
Protocol registration (e.g., PROSPERO)
Comprehensive and replicable literature search
Dual-reviewer screening process
Data extraction templates
Risk of bias and quality assessment tools (e.g., Cochrane RoB, AMSTAR, GRADE)
Qualitative and/or quantitative synthesis (including meta-analysis)
PRISMA flowchart and reporting checklist

Why Are SLRs Important?

SLRs offer several advantages over informal or narrative reviews:

Evidence-Based Decision-Making

SLRs minimize bias by following a transparent methodology, making them ideal for informing clinical guidelines, regulatory decisions, and health technology assessments (HTAs).

Regulatory and HTA Compliance

HTA bodies (e.g., NICE, CADTH, IQWiG, HAS) and regulatory agencies (e.g., FDA, EMA) often require systematic reviews as part of submission dossiers.

Foundation for Meta-Analyses

SLRs provide the evidence base for conducting robust meta-analyses and network meta-analyses.

Publication in High-Impact Journals

High-quality SLRs are often published in leading peer-reviewed journals like BMJ Open, Cochrane Database of Systematic Reviews, The Lancet, and Journal of Clinical Epidemiology.

Supports Market Access and Reimbursement

Incorporating SLRs in Global Value Dossiers (GVDs) or payer submissions strengthens the value demonstration of medical interventions.

Where Are SLRs Published?

SLRs are routinely published in both general and specialized medical journals, as well as used in submissions to regulatory and HTA authorities. Common venues include:

Peer-reviewed journals (e.g., JAMA, Pharmacoeconomics, PLOS ONE, BMJ)
Cochrane Collaboration
Health technology assessment reports
Conference abstracts and posters (ISPOR, ISPE, HTAi)

CliEvi's Systematic Literature Review Services

Our full-service offering ensures complete, compliant, and publication-ready SLRs.

1. Research Question Formulation

We assist in developing a clearly focused question using frameworks like PICO (Population, Intervention, Comparator, Outcome).

2. Protocol Development & PROSPERO Registration

We draft comprehensive protocols and support PROSPERO registration to ensure transparency and reproducibility.

3. Search Strategy Design

Customized Boolean search strings developed by trained information specialists across multiple databases:

PubMed/MEDLINE
Embase
Cochrane Library
Scopus
Web of Science
ClinicalTrials.gov and WHO ICTRP
Grey literature sources

4. Study Screening

Dual-level title/abstract and full-text screening using software like Rayyan, DistillerSR, or Covidence. Inter-rater reliability (e.g., kappa scores) reported.

5. Data Extraction

Standardized and customizable data extraction templates designed for:

Study characteristics
Patient demographics
Interventions and comparators
Outcomes and follow-up
Effect measures (OR, RR, HR, MD)

6. Risk of Bias and Quality Assessment

Tool selection based on study type:

Cochrane RoB 2.0 for RCTs
ROBINS-I for observational studies
QUADAS-2 for diagnostic studies
GRADE for strength of evidence

7. Data Synthesis and Reporting

Narrative synthesis for heterogeneous data
Quantitative synthesis with forest plots and funnel plots if meta-analysis is conducted
PRISMA 2020-compliant reporting

8. Manuscript Writing and Journal Submission Support

Journal selection and scope alignment
Complete manuscript writing and editing
Submission to top-tier journals and support in responding to reviewer comments

How CliEvi Adds Value

Cross-Functional Expertise

Our team comprises epidemiologists, clinical researchers, medical writers, statisticians, and domain experts who ensure methodological rigor.

Tools and Technology

We use validated software tools such as RevMan, EndNote, Mendeley, STATA, and R for data synthesis, referencing, and reporting.

Global Compliance

Adherence to PRISMA, Cochrane, GRADE, and AMSTAR standards to ensure international recognition.

Custom Engagement Models

We offer:

Full-service review development
Modular services (e.g., only search strategy or only data extraction)
Collaborative models with internal research teams

High Publication Success Rate

We ensure content is aligned with the requirements of top journals and HTA bodies to maximize the chances of acceptance.

Industries & Therapy Areas We Serve

Therapeutic Areas

Oncology, Cardiology, Neurology, Endocrinology, Infectious Diseases, Rare Diseases, Pediatrics, Mental Health, etc.

Client Segments

Pharmaceutical and biotech firms
CROs and market access teams
Public health organizations
Academic researchers and healthcare professionals

Contact CliEvi Today

Ready to start a high-quality, publication-ready Systematic Literature Review?

Let our experts handle everything—from protocol development and search strategies to meta-analysis and peer-reviewed publication support.

Contact us now at https://clievi.com to discuss your SLR needs and timelines.