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:
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Strategic RWE planning and execution aligned with your objectives and data environment.
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RWD analytics to support ethics & regulatory submissions, health technology assessments, & stakeholder engagement
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Design of pragmatic and observational studies that reflect real-world clinical practice.
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Translation of findings into policy and access strategies, with a focus on rare, chronic, and complex diseases.​​
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:​
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Development of EGPs tailored for regulatory, reimbursement, and policy decision-making
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Mixed-methods and observational study design, implementation, and analysis, integrating quantitative and qualitative data for a holistic understanding of outcomes
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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:
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Protocol development and scientific oversight for Phase II–IV clinical trials. We can fully manage protocol design or guide your team to lead the work, ensuring efficiency, quality, and long-term independence.
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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.
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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.
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Site readiness assessments and SOP development aligned with ICH-GCP, protocol, and ethics requirements.
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:
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Design and execution of qualitative and mixed-methods studies exploring healthcare systems, patient experiences, and clinical research practices
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Development of interview guides, coding frameworks, and analytical strategies using NVivo and other qualitative tools
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Thematic analysis, framework analysis, and realist approaches to inform program development and evidence translation
What sets us apart from other services
At DocNa, we offer end-to-end management of your research and project needs, from study design and refining research questions to developing all study-related materials, implementation tools, and oversight frameworks.
What truly distinguishes us is how we deliver this support. We combine scientific rigor with operational practicality, ensuring every project is both methodologically sound and feasible in real-world settings.
Our flexible partnership model allows clients to choose the level of support that fits their needs, whether full-service management or guided collaboration with their internal teams to build internal capacity. This approach not only saves time and resources but also fosters long-term independence and sustainable expertise within organizations.