Reducing uncertainty in clinical trials through statistical method and innovation

The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research, where careless planning can quickly lead to patient harm, false or unreliable research results and wasted expenditures.

palleos-services-statistics

To avoid such common pitfalls, great emphasis is put on involving our statistics team at an early stage. This allows us to rigorously formalize and apply advanced mathematical and statistical methods from beginning to end in order to determine optimal actions, minimize risks and execute a high quality clinical trial.

 

The background and expertise of our statistics team lies in both classical “gold standard” statistical methods as well as modern innovative approaches based on Bayesian inference, decision theory and machine learning. This enables us to implement flexible individually tailored solutions for complex problems at the highest quality.

The Statistics Department at palleos healthcare offers full support and services during the complete lifecycle of a clinical trial. This includes:

Statistical consulting starting with the pre-planning phase

Development

Risk identification and assessment

Development

Support in planning clinical study reports (CSRs) regarding the inclusion of analysis results and their visualizations

Development

Validated statistical programming (GAMP-5) and development of analysis databases with complete audit trail and metadata (CDISC ADaM or similar)

Development

Development of innovative trial designs including sample size calculation

Development

Randomization algorithms

Development

Setup

Development of comprehensive statistical analysis plans (SAPs)

Development

Setup

Data review and analysis, leading to the generation of scientific statistical reports and visualization of results (tables, listings, figures)

Closure

Support with publications and scientific presentations, including interpretation of data and results

Closure

Statistical reviews of relevant aspects of the clinical trial, including documents and processes

Development

Setup

Execution

Closure

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