Biostatistics
Comprehensive Data Analysis Across Clinical Development Stages
ERIC excels in analyzing data from all phases of clinical development, leveraging diverse designs and statistical hypotheses. Our expertise includes interim analyses, adaptive and sequential designs, and sample size adjustments to ensure robust and flexible trial outcomes.
Additionally, we actively participate in Independent Data Monitoring Committees (IDMCs), offering unbiased statistical support and aiding in critical decision-making processes independently of the sponsor.
Services We Offer
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1
Precise Sample Size Calculation
We provide accurate and scientifically validated sample size calculations tailored to your study design. Our expertise ensures optimal participant numbers, balancing statistical power, resource efficiency, and reliable trial outcomes.
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2
Expert Statistical Input in Protocol Development
We offer specialized statistical input during protocol design, ensuring robust methodologies, clear endpoints, and optimal trial structures. Our contributions enhance the scientific rigor and feasibility of your study, setting the foundation for successful clinical outcomes.
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3
Comprehensive Statistical Analysis Plans
We develop detailed and tailored Statistical Analysis Plans (SAPs) that outline precise methodologies, endpoints, and analytical approaches for your clinical trials. Our plans ensure clarity, consistency, and regulatory compliance, supporting robust data interpretation and reliable study outcomes.
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4
Expert Interim Analysis for Informed Decision-Making
We conduct thorough interim analyses to evaluate ongoing clinical trial data, providing critical insights for informed decision-making. Our approach ensures timely adjustments, enhances trial efficiency, and maintains the integrity of your study while safeguarding patient safety.
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5
Clear and Comprehensive Tables, Listings, and Figures (TLFs)
We deliver meticulously crafted tables, listings, and figures (TLFs) that present clinical trial data with clarity and precision. Our TLFs enhance data interpretation, support regulatory submissions, and provide actionable insights for informed decision-making.
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6
Comprehensive Statistical Reports & CDISC-Compliant Data Submissions for USFDA
We provide detailed statistical reports and ensure seamless CDISC-compliant data submissions tailored to meet USFDA requirements. Our expertise guarantees accuracy, regulatory compliance, and timely submissions, supporting successful clinical trial outcomes and approvals.
