Biostatistics Services

Comprehensive, high-quality biostatistics services for the success of your clinical trial

Biostatistics is integral to every clinical trial process, driving trial design, trial conduct, data collection, analysis and reporting.

Expertise in biostatistics

StatisticaMedica comprises a high-calibre team of biostatisticians and statistical programmers with expert knowledge of advanced statistical methods, clinical trial design approaches  and global regulatory requirements. The highly experienced team applies scientific principles and therapeutic area knowledge to advise and support our clients throughout the entire clinical development process, from preclinical and clinical trials, through regulatory submission and post-marketing studies.

StatisticaMedica biostatisticians develop and utilise innovative statistical methods to provide results that are accurate, reliable and reproducible. They collaborate closely with the entire project team throughout the trial, thus providing complete transparency and ensuring that the correct data are captured and analysed, ready for submission. StatisticaMedica provides systematic, timely and accurate data and analytics leading to expedited time-to-market and lower development costs.

The breadth and depth of expertise in biostatistics in the StatisticaMedica team enables us to provide our clients with first-class biostatistical services that make a real impact. 

Quality processes

StatisticaMedica actively monitors the validity of your clinical trial data to ensure the high quality of the data output. We understand that insufficient and/or poor quality data can result in higher study costs, delays and failed submissions. The strength and quality of the processes and methodology at StatisticaMedica enable us to deliver high quality Pinnacle data fitness scores in regulatory submissions.
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Rigorous, consistent and regulatory-compliant quality control processes are applied to analysis datasets, tables, listings and figures via independent programming according to dataset specifications or the SAP, as appropriate, to ensure accurate results are provided to the client. 

The value of this data quality process is in stress-testing the statistical validity of the data for the required analysis, i.e., patterns of missing data or the presence of outliers. In our experience, this additional quality control step significantly raises the quality of the analysis and helps to further reduce errors in the data. These measures early in the data analysis process ensure the data reach our expected high standards of accuracy and completeness and, ultimately, save time and costs as data issues are addressed upfront.  

Together, we ensure that your data provide critical insights, and your submissions meet all regulatory requirements, bringing complete competence and absolute integrity to your clinical trial.

Proactive engagement and consultancy

Our consultative approach enables the integrated delivery of high-quality data throughout every phase of the clinical trial process, in all key therapeutic areas in the pharmaceutical, medical device and diagnostics industries. The combination of our in-depth knowledge, innovative biostatistical methods, industry-standard validation processes and rigorous quality control measures results in accurate data in a timely manner and ensures the client gains the most from their trial data.  

The Senior Management team at StatisticaMedica proactively engages with the client at project level, overseeing quality and data delivery. The team also adds value for the client through a consultative approach, providing regulatory statistical support, including demonstrated expertise in our direct interactions with the FDA and EMA for regulatory submissions on our client’s behalf. The Senior Management team understands the mindset of the regulatory statisticians and this insight results in significantly reduced review times and minimises any FDA questions on the data.

Our Biostatistics Services include:

  • Innovative trial design and preparation of the statistical section of the trial protocol 
  • Rationale for sample size and sampling strategies and development of the randomisation schedule 
  • Regulatory body liaison support
  • Preparing for and attending scientific advice meetings with Notified Bodies to obtain approval for the initiation of the trial
  • Development of ICH-compliant statistical analysis plans (SAPs) with mock tables, figures and listings (TFLs)
  • Case Report Form (CRF) review to ensure efficient and accurate data collection
  • Blind dataset testing of statistical programming to validate the implementation of SAP procedures and assess data quality and validity
  • Quality control activities for data integration and validity, including cross-reference checks between source data and analysis outputs, and query handling
  • CDISC (SDTM and ADaM)-submission-ready dataset development and quality control 
  • Tables, listings, and figures programming, validation and quality control
  • Interim analysis planning and support
  • Consultative approach, including advising on compliance and regulatory delivery, to enhance the compliance and quality of our clients’ processes and procedures
  • Generation of statistical reports
  • Review of the statistical section of the clinical study report 
  • Study archive, including generation of ICH-Compliant Trial Master Files