STATISTICAL SERVICES
Revealing the true potential of your trial data with accurate analyses and transparent presentation
All relevant trial data must be analyzed and contextualized before it becomes valuable information. Being clinical information specialists, that’s precisely how we tailor our approach.
We provide a comprehensive set of biostatistical services covering all aspects of the clinical trial process. Our PhD-level experts can fulfill any biostatistical service or analysis request, across all therapeutic areas.
Our aim is to help you form solid and more informed decisions by offering you fast, reliable, and flexible statistical service. We tailor our solutions to meet your requirements, including phase I – IV clinical trials, regulatory submissions, as well as custom calculations and reports.
Our team specializes in statistical programming, medical statistics, pharmacokinetics, and pharmacodynamics, as well as population pharmacokinetics.
Our statistical services include:
- Study Design
- Sample Size and Power Calculations
- Randomization
- Statistical Programming in R, SPSS, and SAS
- Statistical Analyses and Interpretation
- Custom Statistical Reports
- PK/PD
Sample Size and Power Calculations
Determining an appropriate sample size for your study is one of the most fundamental aspects of the success of your study. After all, using the wrong sample size can doom your study from the start. Fortunately, power analysis can find the answer for you. Power analysis combines statistical analysis, subject-area knowledge, and your requirements to help you derive the optimal sample size for your study.
Statistical power in a hypothesis test is the probability that the test will detect an effect that actually exists. We can perform sample size and power calculations for trials of any complexity. We work with you to determine what is the best solution for your study or trial.
Do not worry if your study is not the gold standard two-arm double blind, placebo-controlled trial. We have experience with all types of study structures and can provide sample size and power calculations for multi arm trials, crossover, multiple crossover designs, as well as one arm studies.
For one arm studies we can perform sample size and power determinations with or without hypothesis testing. Additionally, we can perform literature reviews to determine historical controls for one arm studies.
Randomization
Randomization is one of the essential processes in the design of clinical trials. It is a process of assigning patients to groups by chance, in order to prevent bias and achieve optimal patient allocation. The purpose of randomization is to produce comparable groups, which can be analyzed accordingly, with the use of probability theory and statistical models.
Our team of top-level experts is well versed in randomization procedures for various trial types and will work with you to find the best fit for your trial design.
Simple randomization is based on a single sequence of random assignments and is most frequently used in clinical trials. This model is often the best fit for two-arm trial designs with larger patient populations.
Block randomization method is designed to randomize subjects into groups that results in equal sample sizes and is the most preferred option for ensuring a balance in sample size across groups over time. It prevents selection bias and insures against the accidental bias in treatment assignments. Blocks are designed as to keep the number of subjects in each group similar at all times, regardless of the number of patients enrolled in a trial.
Stratified randomization is the preferred when we need to control the number of participants allocated to strati depending on predetermined covariates. Examples include age, gender, baseline disease characteristics, as well as investigational sites or countries. Stratification is achieved by generating separate randomization lists for each stratification, while keeping the overall randomization consistent for the entire study.
Covariate adaptive randomization is the method that prevents the creation of imbalance of important covariates among treatment groups. In this adaptive randomization model, each new participant is assigned to a group, with regards to specific covariates and previous assignment of patients.
Does your study require a 1:1 allocation, or 2:1 allocation, or perhaps a more complex allocation regimen? – These are the frequently asked questions. Their answers have a significant impact on trials, on their feasibility and as acceptance criteria for regulatory authorities.
Pharmacokinetics, Pharmacodynamics, and Population Pharmacokinetics
We can tackle the complexity of substance absorption, distribution, metabolism, and elimination with top-level statistical precision. Pharmacokinetic, pharmacodynamic as well as population pharmacokinetic analyses are performed by PhD-level experts in these fields. Wemedoo AG thus ensures that these complex analyses and their reporting are performed with the care and expertise that they require.
If you require consultation regarding these analyses for your trial, feel free to contact us. We can even assist with the setup of the pharmacokinetic and pharmacodynamic analyses for your trial protocol.
A Full Range of Statistical Services
We recommend to our clients to leverage the benefits of a vertically integrated data management strategy. It is incredible how easy and efficient the entire process becomes when our team follows your clinical trial from the protocol, to the creation and deployment of the eCRF and EDC documents, to data management, statistical analysis plan writing, statistical analysis, and all the way to the writing of the final statistical analysis report.
List of Statistical Services:
- Biostatistical input into study design and protocol
- Sample size and power calculations
- Randomization
- Statistical consultation for CRF design
- CRF review
- Statistical Analysis Plan writing with mock tables
- Interim analyses
- Statistical programming and analysis with TFL generation
- Database transformation and cleaning
- Statistical Programming in R, SPSS, and SAS
- Statistical input into the final CSR
- Data conversion and integration
- Statistical Analysis Report writing
- Statistical Analysis Report writing
- CDISC compliant dataset generation
- SDTM mapping, SDTM Define-XML, reviewer’s guide, SDTM annotated CRF
- ADaM Specifications and ADaM dataset, ADaM Define-XML, reviewer’s guide
- Post submission statistical analyses
- Pharmacokinetics / Pharmacodynamics
- Population Pharmacokinetics
If you need expert statistical support for an ongoing study or perhaps you need additional work or reports written for an already finished trial, please do not hesitate to contact us. We can perform the analyses from any datasets that you may have.