Statistical consultancy
Whether you just need a brief piece of advice, help designing a clinical trial, a statistical analysis plan, or a complete analysis of the results of a study, we can help you.
This well-founded and effective consultancy can add value to your projects and assist you with statistical queries such as:
- When planning a clinical trial, what statistical issues should I consider in the design?
- How many patients should I recruit to my clinical trial to be confident of getting statistically robust results?
- I have already designed the study. Can you write a statistical analysis plan?
- I have already planned how to analyse my data. Will my plan work, or are there any other issues I should consider?
- Can you convert my legacy datasets to a CDISC compliant format?
Remember: it is never too early to get statistical advice. If you are planning a clinical study, it is extremely important to obtain input from a statistician at the design stage. Having a well-designed study is critical for preventing many problems at the data analysis stage.
Statistical analysis
Our statisticians analyse datasets from clinical trials or other sources, using validated statistical software. Our experience in analysing data ranges from small phase I studies with just a few volunteers to large epidemiological datasets with millions of records so the size of your datasets is not important.
From simple descriptive statistics to complex statistical analyses, we offer analysis of data from clinical trials either as part of a complete package from writing the protocol to finalising the clinical study report, or as a standalone service.
All our statistical analyses services are compliant with GCP and suitable for use in clinical trials in a regulatory environment, and of course comply with CDISC standards.
Clinical trial design
The appropriate design of a clinical trial is essential, both to ensure that your trial leads to unbiased conclusions and that it is designed in accordance with ethical guidelines.
Dianthus Medical can offer advice to those planning a clinical trial, providing guidance on:
- Methodological issues, such as the experimental design, optimal efficacy and safety variables, and the use of control groups
- Statistical issues, such as the determination of sample sizes, the use of appropriate statistical tests, and the adjustment for confounding variables
In addition, we can assist you with the writing of:
Ensuring that:
- The planned statistical analyses are appropriate to the study design
- Statistical hypothesis tests are chosen that directly address the study objectives
- There are no methodological flaws that might bias the results obtained from the statistical analyses
- An appropriate sample size has been chosen: we can help calculate an appropriate sample size for your trial if you are unsure how many patients you need