Our professional biostatisticians specialise in designing and planning clinical trials. They work closely with the study team to ensure that the trial is properly designed to answer the research question and to meet regulatory requirements.

Our biostatisticians use their extensive knowledge and experience to help determine the appropriate study design, sample size, randomization, and statistical analysis methods for the trial. They also provide input on data collection, data monitoring, and data analysis plans.

In addition, we ensure that the study is properly powered to detect differences between treatments or interventions, and for conducting simulations to assess the robustness of the study design.

Our expertise in study design, statistical analysis, and regulatory requirements helps to ensure that the trial is properly designed and that the results are accurate and reliable.

Biostatisticians play an important role in interim analysis in clinical trials. Interim analysis involves reviewing the accumulating data from an ongoing clinical trial at predetermined intervals to assess the effectiveness and safety of the intervention being studied. This helps to ensure that the trial is on track, and can also help to identify potential safety issues or other concerns that might require modification of the study protocol.

During interim analysis, our biostatisticians use their statistical expertise to assess the accumulating data, to monitor the progress of the study, and to provide feedback to the study team. They help to ensure that the interim analysis is conducted in a rigorous and unbiased manner, and that any conclusions drawn from the data are reliable.

Our biostatisticians also play a role in determining the timing and frequency of interim analyses, as well as in deciding when to stop a trial early if the intervention is shown to be particularly effective or ineffective.

In addition, our biostatisticians could also work with the study team to adjust the sample size of the trial based on the interim results. This can help to ensure that the study is adequately powered to detect differences between treatment groups and can also help to minimize the overall cost and duration of the trial.

Biostatisticians play a crucial role in survival analysis, which is a statistical method used to analyze the time to an event of interest, such as time to death, time to disease progression, or time to relapse. Survival analysis is commonly used in clinical trials and other medical studies, where it is important to understand the time to an event of interest and to evaluate the effectiveness of interventions on this outcome.

In survival analysis, our biostatisticians use their statistical expertise to design the study and to analyze the data generated from the study. They sometimes work with the study team to determine the appropriate sample size and power for the study, and to select appropriate statistical methods for the analysis.

Biostatisticians also play a critical role in determining the appropriate endpoints for the study, such as overall survival or progression-free survival. They help to ensure that the endpoints are clinically meaningful and that the study is adequately powered to detect differences between treatment groups.

During the analysis of survival data, biostatisticians use a variety of statistical methods, such as the Kaplan-Meier method, Cox proportional hazards model, and parametric survival models. They also help to interpret the results of the analysis and to present the findings in a clear and concise manner.

Adaptive clinical trials are studies that allow for modifications to the study design during the trial based on accumulated data. Our biostatisticians play a critical role in the design and analysis of adaptive clinical trials.

During the planning phase of an adaptive clinical trial, our biostatisticians work with the study team to design the trial with the necessary flexibility to allow for adaptation. They help to select the appropriate statistical methods and to determine the stopping rules for the trial.

During the trial, our biostatisticians monitor the accumulating data and evaluate the trial’s progress. They use their statistical expertise to determine whether changes to the study design are necessary, such as changes to the sample size, the randomization scheme, or the treatment allocation. They may also help to identify potential sources of bias or confounding and recommend appropriate adjustments to the study design.

At the end of the trial, biostatisticians analyze the data and help to interpret the results. They may also help to develop new statistical methods to analyze the data from adaptive clinical trials.

Biostatisticians play a critical role in the design and analysis of bioequivalence and biosimilar trials. These trials are designed to compare the pharmacokinetics (PK) and/or pharmacodynamics (PD) of a test drug to that of a reference drug.

During the planning phase, our biostatisticians work with the study team to design the trial, including determining the appropriate sample size and statistical analysis methods. They help to select the appropriate endpoints, such as maximum plasma concentration (Cmax) and area under the curve (AUC), and determine the bioequivalence or biosimilarity criteria. They may also help to determine the appropriate statistical test, such as a two one-sided test (TOST) or an equivalence test.

During the trial, biostatisticians monitor the data and perform statistical analyses to compare the PK and/or PD of the test drug to that of the reference drug. They may also perform sensitivity analyses to evaluate the robustness of the results to different assumptions or statistical methods.

At the end of the trial, biostatisticians analyze the data and help to interpret the results. They may also help to develop new statistical methods to analyze the data from bioequivalence and biosimilar trials.

Biostatisticians play a critical role in the validation of biomarkers, which are used to indicate disease status or predict response to treatment.

During the planning phase, biostatisticians work with the study team to design the validation study, including determining the appropriate sample size and statistical analysis methods. They help to select the appropriate endpoints, such as sensitivity, specificity, positive predictive value, and negative predictive value, and determine the validation criteria. They may also help to determine the appropriate statistical test, such as a receiver operating characteristic (ROC) curve analysis.

During the validation study, biostatisticians monitor the data and perform statistical analyses to evaluate the performance of the biomarker. They may also perform sensitivity analyses to evaluate the robustness of the results to different assumptions or statistical methods.

At the end of the study, biostatisticians analyze the data and help to interpret the results. They may also help to develop new statistical methods to validate biomarkers and assess their clinical utility.

Biostatisticians play an important role in SDTM (Study Data Tabulation Model) conversion programming and validation.

SDTM is a standard format for the submission of clinical trial data to regulatory authorities, and biostatisticians help to ensure that the data are properly formatted and that the conversion process is accurate and reliable.

During the SDTM conversion process, biostatisticians may work with the clinical data management team to review the data and ensure that it is complete and accurate. They may also work with the SAS programmers to develop the conversion programs and validate the output to ensure that it meets the requirements of the standard.

Biostatisticians also play a role in the validation of the converted data. They may perform statistical analyses on the data to ensure that it is consistent with the original data and that there are no errors in the conversion process. They may also work with the clinical team to interpret the data and ensure that it meets the requirements of the regulatory authorities.