Biostatistics are a critical element to the foundation of your study’s design, outcomes, and data analysis. Accurate and robust study design, sample size selection, and analytic approach are essential to your study’s scientific and ethical adequacy. Together, these criteria will:
Address your study’s hypothesis, providing meaning to your research investment
Ensure that your study data is clean, reliable, and reproducible, reinforcing the trust of regulators, scientific publishers and potential investors
Prevent the use of excessive or inadequate number of research participants, minimizing the potential risk of harm
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These objectives can only be achieved by establishing an objective framework for conducting the research. Such framework must include a comprehensive and detailed statistical strategy and methodology to analyze the data. This is why the development of a clear and detailed Statistical Analysis Plan (SAP) is essential in order to anticipate and control for potential protocol deviations and data anomalies. Furthermore, the SAP prospectively outlines all planned statistical testing, along with the justification for the selected statistical tests.
Our Biostatistics Services
We offer extensive and personalizable statistical services to fit the design and objectives of your study. Our expert biostatisticians and statistical programmers are skilled in the design and analysis of Phase I-IV clinical trials and health surveys. Whether your intended audience is a regulatory body, a scientific journal, or a market research group, our expert staff will help you select and execute the most appropriate statistical plan to meet the expectations of your audience and communicate your findings in an appropriate digestible way.
Our biostatistics services include:
Study Design and Analysis
- Protocol design
- Statistical Analysis Plan development
- Statistical programming
- Confirmatory and exploratory analyses
- Statistical results interpretation and presentation
Reporting and Consulting
- Statistical analyses for manuscripts and publications
- Customized statistical reports
- Pooled analyses
- Knowledge discovery within databases (data mining)
Our Biostatistics Approach
At ethica CRO, our statistical programs are rooted in the protection of the research participant. We firmly believe that the inclusion of human participants in scientific research must be justified by the production of valid and reliable research data from the projects we manage.
Our Biostatistics Procedures
ethica CRO’s statistical programs are aimed at maximizing the integrity of your study data. Our biostatisticians employ the latest and most appropriate statistical techniques to maximize your data’s potential, no matter the study design. All of our statistical software is 21 CFR Part 11 compliant.
Training and information concerning study conduct and procedures will be provided to all parties during the study kick-off meeting. At this time, our team of biostatisticians and statistical programmers will introduce potential study designs and develop the Data Management Lifecycle Plan. This plan will outline all essential activities pertaining to data collection, maintenance, usage, and archival throughout the duration of your research program.
During the medical writing process, our biostatisticians and medical writers will work closely with you to ensure that the proper statistical strategy, methods of analysis, and primary and secondary outcomes are specified in the Study Protocol. They will also ensure that the protocol outlines strategies to address potential issues concerning your study data, such as outliers and missing data.
Once the Study Protocol is finalized and approved, we will develop the Statistical Analysis Plan, a comprehensive plan describing the statistical strategy and methodology of your study, as well as the presentation of data analysis, including main and interim analyses. Proper compliance to your Statistical Analysis Plan is essential in the prevention of statistical and operational biases in order to safeguard your data’s validity and integrity.
To facilitate the registration of your investigational product with regulatory agencies, our statistical programs are developed in full accordance with the Clinical Data Interchange Standards Consortium (CDISC), the Study Data Tabulation Model (SDTM), and the Analysis Data Model (ADaM).