Precision in Numbers

Biostatistics

Excellence in Insights

Biostatistics stands as a cornerstone in both preclinical and clinical studies, playing a pivotal role in shaping study design, execution, data analysis, and reporting. At Fyzil Global, our Biostatisticians are committed to upholding your project’s timelines and providing unwavering support throughout the development cycle. We implement rigorous quality controls at every stage to ensure the delivery of high-quality results.

In tandem, our Data Managers and Medical Writers collaborate closely to ensure precise data capture while avoiding the collection of extraneous information.Our Biostatisticians are available on a flexible per-project or full-time equivalent (FTE) basis, aligning with your unique requirements.

Trust us to navigate the complexities of your research endeavors with precision and dedication, driving impactful insights and advancing medical knowledge.

Here's how Fyzil Global can assist you

At Fyzil Global, we offer comprehensive Biostatistics services tailored to meet the unique needs of your clinical research projects. Our team of experienced Biostatisticians provides expertise and support across all phases of your study, ensuring robust study design, accurate data analysis, and precise reporting.
  • Study Design and Endpoint Development Guidance: We collaborate with you to develop study designs and define appropriate endpoints tailored to your research objectives.
  • CRF Review:Our team reviews Case Report Forms (CRFs) to ensure data collection is optimized for statistical analysis.
  • Statistical Consulting: We provide expert statistical consulting to guide you through complex data analysis challenges and decision-making processes.
  • Sample Size Estimations and Randomization Schemes: We conduct sample size estimations and develop randomization schemes to ensure your study has adequate power and balance.
  • Statistical Analysis Plan (SAP) Development: Our team creates comprehensive SAPs, including mock tables, figures, and listings (TFLs), outlining the statistical methods and procedures for your study.
  • Data Review Sessions: We conduct regular data review sessions to monitor data quality, identify trends, and address any issues that may arise during the study.
  • Cutting-Edge Software Packages: We utilize industry-leading software packages for electronic data capture (EDC) and paper-based data capture, enabling us to efficiently build and manage clinical databases. Our Data Managers oversee database construction and data cleaning, providing a single point of contact for all data management activities.
  • SAS® Programming and Validation: Our SAS® programmers generate and validate analysis datasets and ensure the accuracy and integrity of statistical results.
  • Statistical Analyses and TFLs for Clinical Study Reports: We perform statistical analyses and prepare TFLs for inclusion in clinical study reports, providing insights into study outcomes and results.
  • Derived Analysis Data Sets: We create derived analysis datasets to facilitate secondary analyses and exploratory research.
  • CDISC-Compliant Data Sets: Our team ensures that all datasets are compliant with CDISC standards, facilitating interoperability and regulatory submission requirements.
  • FDA Submission-Ready Package: We prepare FDA submission-ready packages, including analysis datasets, TFLs, and documentation, to support regulatory submissions.
  • Support for Study Design via Power Calculations: We assist in study design by performing power calculations to determine sample size requirements and ensure study feasibility.

Trust us to navigate the complexities of your research endeavors with precision and dedication, driving impactful insights and advancing medical knowledge.

Get in touch with us today to learn how we can support your clinical research endeavors and unlock the full potential of your data and drive meaningful insights.

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Why Choose Us

  • Tailored Solutions: We understand that every project is unique. That’s why our Biostatistical approach is alighed perfectly to suit your deisired objectives and needs.
  • Flexibility: Whether you require support for a single project or ongoing FTE engagement, we offer flexible options to accommodate your requirements and timelines.
  • Efficiency and Effectiveness: With our expertise and advanced technologies, we ensure that your data management processes are streamlined, efficient, and compliant with industry standards.
  • Quality Assurance: Quality is at the core of everything we do. Fyzil Global implements stringent quality control measures at every stage of the research process to ensure the integrity and accuracy of your data.
  • Client-Centric Approach: At Fyzil Global, we prioritize client satisfaction above all else. We strive to build long-lasting relationships based on trust, transparency, and open communication.

 

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