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Research & Evidence Generation Strategy

Real-World Evidence (RWE)

 

DocNa  transforms real-world data (RWD) into evidence that informs clinical, regulatory, and policy decisions.

Our approach combines scientific rigor, real-world insight, policy expertise, and patient perspectives to generate evidence that drives decisions and resonates with regulators, payors, and patients.

We offer a flexible approach, providing either full management of your RWE program or a tailored plan to guide your team, saving time while building long-term capability.


Our expertise includes:

  • Strategic RWE planning and execution aligned with your objectives and data environment.

  • RWD analytics to support ethics & regulatory submissions, health technology assessments, & stakeholder engagement

  • Design of pragmatic and observational studies that reflect real-world clinical practice.

  • Translation of findings into policy and access strategies, with a focus on rare, chronic, and complex diseases.​​

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Evidence Generation Planning (EGP)

 

DocNa partners with clients to design comprehensive, fit-for-purpose evidence generation plans that strengthen regulatory and reimbursement submissions.
Our services include:​

  • Development of EGPs tailored for regulatory, reimbursement, and policy decision-making

  • Mixed-methods and observational study design, implementation, and analysis, integrating quantitative and qualitative data for a holistic understanding of outcomes

  • Gap and needs analysis and evidence mapping to identify opportunities, address data limitations, and align research with organizational priorities.

Clinical Trial Oversight

 

DocNa provides scientific and operational support & oversight to ensure high-quality, compliant, and efficient clinical trial conduct.
Our services include:

  • Protocol development and scientific oversight for Phase II–IV clinical trials. We can fully manage your study or guide your team to lead the work, ensuring efficiency, quality, and long-term independence.

  • Monitoring and quality assurance to maintain data integrity, participant safety, and regulatory compliance; either fully handled by DocNa  or in partnership with your team to optimize resources and build internal capabilities.

  • Regulatory insights and submission support for Health Canada, FDA, and other global agencies. We provide full regulatory submissions or guide/ mentor your team to navigate submissions confidently, saving time and enhancing internal expertise.

  • Site readiness assessments and SOP development aligned with ICH-GCP, protocol, and ethics requirements. 

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Qualitative and Mixed-Methods Research

 

DocNa brings extensive expertise in qualitative methodologies to generate actionable insights that enhance research, policy, and patient-centered initiatives.
Our expertise includes:

  • Design and execution of qualitative and mixed-methods studies exploring healthcare systems, patient experiences, and clinical research practices

  • Development of interview guides, coding frameworks, and analytical strategies using NVivo and other qualitative tools

  • Thematic analysis, framework analysis, and realist approaches to inform program development and evidence translation

What Sets Us Apart

 

At DocNa , we manage your research end-to-end, from refining your research question and study design to developing all materials, implementation tools, and oversight frameworks.

 

What distinguishes us is how we deliver: combining scientific rigor with real-world practicality, so every project is both methodologically sound and operationally feasible.

 

Our flexible partnership model lets you choose your level of support, full-service management or guided collaboration that builds your team's internal capacity, saving time and resources while fostering long-term, sustainable expertise within your organization.

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