Resources · Specialist subject
Clinical Trial Services
Biostatistics as the cornerstone of clinical trial design, execution, and interpretation — ensuring studies are scientifically sound and appropriately powered for regulatory approval.
Biostatistics services of RDA are the cornerstone of clinical trial design, execution, and interpretation. Biostatistical support by RDA will ensure that your clinical development programme and inherent studies are scientifically rigorous, appropriately powered, and capable of generating reliable evidence for regulatory approval and clinical use. RDA’s expertise for clinical development is focused on haematology and oncology.
The following list describes the services we provide out of RDA.
Study Design & Sample Size Calculation
- Determining appropriate study endpoints and statistical methods.
- Calculating sample size and power to ensure the trial can detect meaningful differences.
- Supporting adaptive, Bayesian, or innovative trial designs where appropriate.
- Defining estimands for analyses, which includes primary, secondary, exploratory endpoints for the protocol.
- Specialist service of RDA includes longitudinal and advanced survival analysis.
Randomisation & Blinding
- Developing randomisation schemes to eliminate bias.
- Ensuring proper stratification and allocation concealment.
- Supporting blinding processes to maintain trial integrity.
Statistical Analysis Plan (SAP)
- Creating detailed SAPs to predefine methods of data handling, analysis, and reporting.
- Expanding on details for estimands for analyses, which includes primary, secondary, exploratory endpoints.
- Outlining interim analysis and stopping rules.
Interim Analyses & Data Monitoring
- Conducting planned interim analyses to assess efficacy, futility, or safety.
- Supporting Data Monitoring Committees (DMCs) with independent statistical reporting.
Final Analysis & Reporting
- Performing comprehensive statistical analyses of trial outcomes.
- Generating tables, listings, and figures (TLFs) for regulatory submissions.
- Supporting clinical study reports (CSRs) and scientific publications.
Advanced Analytics & Modelling
- Applying advanced survival analysis, longitudinal modelling, and mixed-effects approaches.
- Utilising real-world data and external controls where applicable.
- Leveraging cutting edge methodology and simulation techniques to optimise trial outcomes.
- Services can be provided tailoring your needs, ie. by project, or allocation of resources to be utilised.