From planning to statistical proof – precision that drives clarity

Biometric Services

The Biometrics department at Alcedis delivers robust statistical solutions tailored to the needs of modern clinical research. From study design to final analysis, we support our clients with methodological expertise, validated programming, and regulatory-compliant deliverables. Whether it’s a first feasibility estimate or a full CDISC-compliant dataset, our biometricians ensure that numbers become meaningful.

  • 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
Expertise

Experienced biometricians guide study design decisions with scientifically sound and regulatory-aligned recommendations.

Analysis Outputs

We deliver validated, reproducible results—ensuring that every table, listing, and figure reflects the study data with precision.

Exports

Our programming and exports meet global submission standards, ensuring compatibility with authorities and external partners.

Collaboration

Close cooperation with Data Management and Medical Writing allows for seamless handoffs and interpretation of results.

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.

"We are collaborating with Alcedis for many years in several indications and as such in some local oncology studies. I believe one of the success factors for Alcedis is their high commitment and the hard work they bring into assigned projects. Besides great expertise in clinical research, another sweet spot is definitely their IT solutions for innovative data capture in clinical studies."

Dr. Lars Mühlenhoff
AstraZeneca, Director Medical Affairs Oncology

"I have made very good experiences with Alcedis in several global projects over the last years. I recommend their professionalism and hands-on mentality as a full service CRO with excellent eCRF solutions. Working with such a dedicated team was joyful on top and I can fully acknowledge Alcedis as a trusted partner!"

Alexey Medvedchikov
Boehringer Ingelheim, Regional Medical Affairs Operations

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