Execute your clinical research project with greater Clarity, Efficiency & Accuracy!
Biostatistics expertise for the design & analysis of your biotech R&D and clinical trials.
We’ve got the details covered…
We help you to develop and implement a clear plan of action from the outset of your project to ensure you remain on your optimal trajectory for the project duration.
In the initial stages we refine you research questions, fine tune your hypotheses for precise testing and enable a statistical analysis plan that optimizes your study results. Study power and required sample size can vary wildly as a function of statistical test and data type. Determining a statistical analysis plan up front is key as it enables us to calculate the most appropriate sample size and power for your study.
We advise on data collection and inputting techniques that reduce the need for data cleaning and preparation at the analysis stage, whether STDM and ADaM for clinical trials or the collation of RWD for modelling purposes. This helps to streamline the study process and enables a more efficient investigation of your research questions.
We use a rigorous approach to ensure the most appropriate statistical methodology has been implemented at the final analysis stage. We will fine tune your statistical analysis plan as needed in line with any unexpected developments arising from the nuances of real-world data. We follow protocol to ensure your final analysis is as accurate and free from bias to every possible extent. We then write up the results of your study and guide your interpretation to fully ensure that any conclusions are correct and concise.
Biostatistics help for R&D or exploratory studies
Whether you are a pharma or medical device start-up or SME, the analysis of early-stage testing and the biostatistical design of pre-clinical R&D studies for your therapeutic can help to provide insight and pre-clinical validation sufficient for entry into clinical trials. We can also perform initial research and comparative studies of existing therapeutics as a preparatory step towards evaluating the efficacy and safety of a novel therapeutic under development.
Biostatistical design & analysis of Biotech & medtech clinical trials
Up-to-date biostatistical methods and clinical study design techniques ensure that your research is as innovative as your therapeutic. Assistance in the development of a statistical analysis plan for your trial, including sample size calculations, adjustments for missing data, and establishing early-stopping conditions are just some of the ways our biostatistical expertise could add value to your project.
Biomarker-related components can be woven into your clinical trial alongside traditional biostatistical approaches. Particularly in the context of pharmaceutical therapeutics, biomarker-guided clinical trials allow a novel therapeutic to be tailored to the patient, or a study population to be restricted to specific biomarkers. In either case, this increased precision improves the chance of a successful trial and allows treatment efficacy to be more clearly determined.
An adaptive clinical trial design, in the case of medical device trials, ensures that modifications can be made to your device during the trial. For pharmaceutical trials, they provide the flexibility to end an unproductive trial early or update treatment doses without running subsequent dose-finding trials. These services can help to establish the reasonable assurance of safety & effectiveness for your therapeutic.
Biostatistics Services for Pharma Start-ups & SMEs
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Biostatistics Services for MedTech Start-ups & SMEs
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