Clinical trial design is one of the most important steps on the path to assessing or establishing the viability of a novel drug, device, biologic, diagnostic or intervention.
VIETSTAR BIOMEDICAL RESEARCH has proven expertise in study design across all development components for these trials. The VIETSTAR BIOMEDICAL RESEARCH Trial Design team is comprised of clinicians, as well as statistical experts, who provide the leadership necessary to design a study that will meet its scientific and regulatory objectives. This has included both registration trials spanning all trial components and post-marketing studies. VIETSTAR BIOMEDICAL RESEARCH has experience in designing trials of diverse types, including:
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Prospective Randomized
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Bayesian Adaptive
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Registry
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Sequential Parallel Comparison Design
Protocol review/input
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Conduct literature searches as required
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Liaise with project managers, Study Physicians and Investigators to ensure the best study design
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Co-ordinate with data management to ensure compliance with internal systems
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Ensure protocol undergoes internal review as per your company procedures
Informed Consent Form design
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Assessing the completeness of Consent Form (review the Consent Checklist)
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Assistance with the development of a project-specific consent form