- Statistical consulting for protocol development and study design
- Contribution to the statistical section of study protocols
- Sample size estimation and power calculations
- Statistical Analysis Plans (SAP)
- Programming of tables, listings, and figures (TLFs)
- CDISC-compliant dataset creation and export
- Interim analyses and adaptive design support
- Final statistical analysis and reporting
- Generation of statistical appendices and standalone reports

From Sample Size to SAP – Strong Foundations for Solid Results
- Early-phase statistical planning is crucial for the credibility of every clinical study. At Alcedis, we assist with methodological input for the study design, provide statistical justification in the protocol, and calculate sample sizes that are both scientifically and operationally feasible.
- Our biometricians develop detailed Statistical Analysis Plans (SAPs) to define all analyses in advance—ensuring transparency, reproducibility, and compliance with ICH-GCP and sponsor requirements.

Statistical certainty in a changing environment
Biometric challenges span across data complexity, regulatory standards, and timelines. Here’s how Alcedis approaches them:
- Expert Programming: We combine validated tools with expert insight to develop statistical outputs that are ready for submission. All programs are rigorously reviewed and version-controlled, reducing error and rework.
- Submission-Ready Data: Our CDISC-compliant datasets (SDTM, ADaM) support seamless integration into submission packages. With built-in quality checks and traceability, they meet the expectations of international regulatory bodies.
- Insightful Statistical Summaries: Beyond numbers, our biometricians focus on clarity. Whether for final reports, regulatory submissions, or internal decision-making— we prepare statistical results that are not only correct but easy to interpret and act upon.

Latest Whitepaper
Our summarization of EUCROF's propositions on leveraging remote source data verification and reviews (rSDV/rSDR) in clinical trials. Gain insights and recommendations for seamless integration, ensuring data consistency and participant privacy while reducing site burden.

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