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Clinical Study Design Support for HEOR and HTA Success

A well-designed clinical study is central to the appropriate collection of evidence related to a new product, service, or device. The outcomes and data collected during such studies are integral to your Health Technology Assessment (HTA) submission and play a critical role in subsequent market access considerations and payer assessments. However, designing clinical studies is a complex process that requires a nuanced understanding of technical, clinical, and societal factors.

At Optimax Access, we specialize in helping our clients optimize their clinical studies from a Health Economics and Outcomes Research (HEOR) perspective. By aligning your study design with the requirements of value demonstration and payer decision-making, we ensure that your value proposition is compelling and resonates with stakeholders.

Our Expertise

Whether your study is observational or experimental, we provide comprehensive support and guidance to help you generate valuable, reliable, and actionable data to demonstrate the benefits of your product. Our multidisciplinary team of clinicians, statisticians, and health economists collaborates closely with you to design studies that meet the highest standards of evidence generation for HTA and market access.

We also help you understand the key drivers of your value proposition and ensure that they are included in your studies. The right Patient-Reported Outcomes (PROs), quality-of-life tools, and healthcare resource use tools will be incorporated to strengthen your evidence base.

We Help You Design the Following Types of Clinical Studies:

Randomized Controlled Trials (RCTs): We ensure that your RCTs are designed to provide robust evidence of clinical and economic value, addressing endpoints relevant to both clinical efficacy and cost-effectiveness.
Observational Studies: From cohort studies to case-control designs, we help you gather real-world evidence (RWE) that supports the long-term effectiveness and utility of your product.
Prospective Studies: We guide you in planning forward-looking studies that capture the necessary data for future HTA submissions and payer discussions.
Retrospective Studies: We support the analysis of historical data to inform decision-making and supplement your evidence package.

Key Benefits of Our Support

Customized Study Designs: Tailored to meet specific HTA and market access needs.
Regulatory and Payer Alignment: Designed with a deep understanding of global HTA requirements, payer expectations, and reimbursement landscapes.
Expertise Across Therapeutic Areas: Extensive experience in a wide range of therapeutic domains, including precision medicine, gene therapies, oncology, and rare diseases.
Integrated HEOR Insights: Seamless incorporation of health economics considerations into your clinical study design.

Why Choose Optimax Access?

At Optimax Access, we combine scientific rigor with strategic insight to deliver clinical study designs that optimize your product’s success. By ensuring that your studies generate the right data for HTA submissions and payer assessments, we help you build a strong value proposition and achieve efficient market access.

Get in Touch

Contact us today to learn more about how we can support your clinical study design needs. Together, we can generate the evidence required to demonstrate the full value of your innovation and drive successful market access outcomes.