Highly experienced statistics support is often the key to the p value.
Ergomed offers a full range of biostatistical services for clinical trials across all phases, non-interventional studies and retrospective data analyses. Our statisticians each have more than 25 years of experience and have, collectively, worked on trials in most therapeutic areas.
Our biostatistics team works within regulatory standards and international guidelines to support all aspects of clinical research, from statistical consulting, first-in-human studies and publication support to electronic common technical document (eCTD)-compliant submission packages. The team is also supported by a highly-skilled group of SAS programmers spanning both the US and Europe.
We offer statistical consulting for complex statistical methodology and implementation of adaptive designs, regulatory guidance for strategic planning, and representation at meetings with global regulatory authorities. Analyses and computations are performed with industry-standard, validated software tools.
Our expert biostatistics teams offer:
- Statistical consulting on study design
- Statistical analysis and reporting
- Development of the statistical analysis plan
- Sample size and power calculations
- Study randomization schemes
- Writing statistical sections of the protocol and clinical study report
- Tables, listings and figures
- Creation of CDISC, SDTM, and ADaM domains with full documentation and validation
- Support for data safety monitoring board and independent data monitoring committees
- Non-compartmental pharmacokinetic and pharmacodynamics analysis
- Integrated summaries of efficacy and safety
- Assisting risk-based monitoring activities.