Our services ensure that your clinical trial is built on a robust methodological foundation, increasing the likelihood of successful execution, regulatory acceptance, and meaningful scientific outcomes.
1. Planning & Design selection services
F-stats consulting supports you from the planning phase of your clinical trials, providing advanced expertise in biostatistical methodology. We work closely with your teams to define the optimal study design, select relevant evaluation criteria, estimate the required sample size, and draft essential methodological documents (protocols, SAPs). We also offer customized randomization solutions and prepare your files for interactions with regulatory authorities, in order to maximize the robustness and compliance of your trials.
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Clinical Trial Design Consulting
F-stats consulting provides expert guidance in selecting the most appropriate clinical trial design for your research objectives. This includes support in defining the primary and secondary research questions, choosing between parallel, crossover, adaptive, or platform trial designs, and ensuring alignment with regulatory expectations and scientific best practices. Our team helps you navigate the iterative design process, from conceptual planning to implementation, to maximize the validity and impact of your study.
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Protocol Development and Methodology
We assist in the development and optimization of clinical trial protocols, ensuring clarity in objectives, inclusion/exclusion criteria, endpoints, and statistical analysis plans. Our experts ensure that your protocol is scientifically rigorous, feasible, and compliant with international standards, laying a solid foundation for successful execution and regulatory approval.
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Sample Size and Power Calculations
Our biostatistical team performs detailed sample size and power calculations tailored to your study’s endpoints and design. We ensure that your trial is adequately powered to detect meaningful differences, while avoiding unnecessary resource expenditure. This includes planning for interim analyses and adaptive modifications if needed.
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Selection of Endpoints and Outcome Measures
We guide you in selecting clinically relevant and measurable primary and secondary endpoints, ensuring they align with your research objectives and regulatory requirements. Our team helps define robust outcome measures to support clear, interpretable, and impactful trial results.
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Patient Population and Entry Criteria Definition
F-stats consulting assists in defining the target patient population and entry criteria, balancing scientific rigor with practical feasibility. We help optimize inclusion/exclusion criteria to ensure safety, reduce bias, and facilitate timely recruitment, while maintaining generalizability of results.
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Statistical Analysis Plans (SAPs)
Our team prepares comprehensive and detailed SAPs that outline all planned statistical analyses for your clinical trial, including the definition of analysis populations, methods for handling missing data, and specifications for the presentation of results. By providing this service, F-Stats ensures methodological transparency, regulatory compliance, and a clear roadmap for both interim and final analyses, supporting the scientific integrity of your study from the outset.
2. Data Services: Collection, Cleaning, Preparation
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Data Collection Strategy and Implementation
F-stats consulting designs and implements robust data collection strategies aligned with your clinical trial protocol. We develop and customize Case Report Forms (CRFs) and configure electronic data capture (EDC) systems to ensure accurate, consistent, and efficient collection of all required data across study sites. Our team provides comprehensive training for site staff to guarantee protocol adherence and high-quality data entry.
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Database Setup and Management
We create secure, study-specific clinical trial databases that support efficient data entry, storage, and retrieval. Our solutions ensure regulatory compliance, data privacy, and seamless integration with other trial management systems. We oversee the entire database lifecycle, from initial setup to final lock, maintaining data integrity at every stage.
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Data Cleaning and Quality Assurance
Our team conduct rigorous data cleaning processes, including automated and manual validation checks, discrepancy management, and medical coding. We identify and resolve inconsistencies, missing values, and errors to deliver a clean, reliable dataset ready for analysis. Quality assurance measures are applied throughout to ensure data accuracy and regulatory compliance.
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Data Preparation and Validation
F-stats consulting prepares your clinical data for statistical analysis by standardizing datasets, performing medical coding, and ensuring alignment with analysis plans. We validate datasets through systematic review, user acceptance testing, and final database lock procedures, guaranteeing that only high-quality, analysis-ready data is delivered for reporting and regulatory submission.
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Data Management Plan (DMP) Development
We develop comprehensive Data Management Plans that outline all procedures for data collection, handling, storage, quality control, and security. The DMP serves as a roadmap for all data-related activities, ensuring standardized processes, regulatory compliance, and clear communication among trial stakeholders.
3. Statistical Analyses and Results Interpretation
These services ensure that your clinical trial data is analyzed rigorously, results are interpreted accurately, and findings are communicated effectively to all stakeholders.
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Statistical Analysis Planning and Execution
F-stats consulting develops and implements comprehensive statistical analysis plans (SAPs) tailored to the clinical trial’s objectives and data structure. Our team selects and applies appropriate statistical methods: such as t-tests, ANOVA, regression models, survival analysis, and nonparametric tests: based on the type of data and study design. We ensure all analyses adhere to regulatory standards (e.g., ICH E9), address multiplicity, and are reproducible and transparent.
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Descriptive and Inferential Statistics
We provide detailed descriptive statistics to summarize participant characteristics, treatment adherence, and key outcome measures using means, medians, standard deviations, frequencies, and visualizations. Inferential analyses are conducted to test hypotheses, compare groups, and estimate treatment effects, ensuring results are robust and interpretable for both technical and non-technical stakeholders.
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Advanced and Specialized Analyses
Our experts conduct advanced statistical analyses, including survival analysis (Kaplan-Meier, Cox regression), longitudinal data analysis, Bayesian methods for small samples, and meta-analyses. We tailor these approaches to address specific trial requirements, such as rare diseases, adaptive designs, or interim analyses, ensuring the most appropriate and powerful methods are used for each scenario.
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Results Interpretation and Communication
F-stats consulting translates complex statistical findings into clear, actionable insights for clinical and regulatory audiences. We interpret results in the context of clinical relevance, study limitations, and regulatory expectations, preparing comprehensive reports, visual summaries, and presentations to ensure findings are understood and can inform decision-making.
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Regulatory Submission Support
We prepare and review statistical sections of Clinical Study Reports (CSRs), ensuring all analyses and interpretations meet the requirements of regulatory authorities. Our team provides responses to regulatory queries and supports interactions with agencies to facilitate successful trial submissions and approvals.
F-Stats Consulting provides end-to-end statistical expertise, from protocol development to publication, ensuring methodological rigor and regulatory compliance at every stage.