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Expertise

Market Access

Evidence-focused integrated access solutions at the nexus of clinical and regulatory experience.

Understanding the Market Potential

VCLS has a strong understanding of HealthTech investors’ requirements and has helped hundreds of emerging biopharmaceutical and medical technologies companies build their business case and strategy.

In order to take sound investment decisions, HealthTech companies and their investors need to understand the market potential for their product. This implies understanding the environment in which a product will position itself.

We can help you:

  • Understand the unmet medical need
  • Estimate the size of the possible target populations
  • Understand the competition
  • Understand the pricing and reimbursement potential
  • Estimate the revenue potential
  • Formule the value propositions
  • Plan your pricing and market access strategy

You may also be interested in Neighborhood, the first regulatory life science innovation center.

Understanding the HTA Evidence Requirements

We have handled 1/4 of all consolidated or non-consolidated EMA/HTA parallel consultations and 1/2 of the Orphan Drugs Parallel Consultations in Europe.

Regulators’ and Health Technology Assessment Authorities’ requirements are not the same. It is critical to bridge this gap as early as possible during the product development stage to avoid the common “too little too late” outcome for products receiving a marketing authorization and trying to launch without the required evidence to support their value proposition.

We can help you:

  • Prepare and conduct consolidated or non-consolidated parallel consultations with regulatory and HTA authorities
  • Prepare and conduct multi-HTA EUnetHTA Consultations
  • Perform gap analysis of existing versus required evidence
  • Build an evidence generation roadmap

You may also be interested in our Regulatory Solutions.

Expert Voice

Hear insights from our experts at the World Orphan Drug Congress and Pharma Pricing Market Access Congress:

The World Orphan Drug Congress

 

Pharma Pricing & Market Access Congress

 

Planning Health Economic and Outcomes Research (HEOR) Evidence Generation

VCLS outcomes researchers and health economists have collectively supported the integration of clinical, economic and humanistic endpoints into hundreds of clinical trials in Europe and the US.

In order to have the required evidence to obtain favorable HTA recommendations and appropriate pricing and reimbursement conditions, it is necessary to plan HEOR evidence generation alongside the clinical trial program.

We can help you:

  • Perform gap analysis of available vs required evidence
  • Plan the evidence generation strategy
  • Select and integrate clinical, economic and humanistic outcomes research parameters into clinical trials and studies
  • Build economic models

You may also be interested in our Clinical Expertise.

VCLS Expertise