Biostatistics in clinical research

Our services in biostatistics:

Statistical study planning
Creation of statistical analysis plans
Statistical programming & analysis
Creation of tables, listings and figures (TLFs)
Statistical review & method development
Subgroup, sensitivity and interim analyses
Planning, implementation and evaluation of interim analyses
Interim Data Reviews
Quality assurance & testing for regulatory compliance

Our range of services includes:

We offer a comprehensive range of services in the field of biostatistics that is specially tailored to the requirements of your clinical studies. Our aim is to support you from study planning to final analysis with scientifically valid and regulatory compliant statistical solutions.

Study planning & design

In the early phase of your study project, we work with you to develop a customized statistical study design that is optimally tailored to your research question.This includes

Selection of a statistically suitable study design
Well-founded sample size and power calculations Careful definition of primary and secondary endpoints
Creation of detailed statistical analysis plans (SAP)
Conduct of transparent and comprehensible data analyses
Compliance with regulatory requirements

Statistical programming & analysis

Using modern statistical software tools such as SAS and R, we carry out the statistical analyses of your clinical trials – promptly, reliably, transparently and in compliance with regulatory requirements.

Our services range from exploratory data analyses and interim analyses for decision support to final efficacy and safety evaluations after study completion.

We develop, validate and implement complex statistical programs for the creation of:

Tables, listings and figures (TLFs) for study reports, submissions or publications
ADaM data sets (Analysis Data Models) as the basis for verifiable analyses
SDTM data sets (Study Data Tabulation Models) for structured archiving and regulatory submission

It goes without saying that we follow international standards, in particular CDISC (Clinical Data Interchange Standards Consortium), as well as regulatory requirements from the EMA, FDA and other authorities. Our evaluations are comprehensible and fully documented – including tested program codes and validation reports relating to raw data, analysis data sets and results.

The aim of our statistical programming is to deliver reliable, comprehensible and regulatory recognised results – as a basis for your well-founded decisions in the further development process of your medicinal products or medical devices.

Statistical review & method development

An expert statistical review forms the basis for reliable results and regulatory-compliant study progression. Our experienced biostatisticians check your existing study documents – such as study protocols, statistical analysis plans (SAPs) and case report forms (CRFs) – for statistical plausibility, consistency, completeness and regulatory compliance. The aim is to identify potential methodological weaknesses at an early stage and ensure the scientific quality of your study by making suitable adjustments.

In addition, we develop innovative statistical analysis approaches to provide targeted answers to complex or specific questions. These include, among others:

Subgroup analyses to evaluate relevant patient groups in a differentiated manner and make clinically significant effects visible
Interim analyses, with clearly defined decision criteria for possible study adjustments, e.g. for safety aspects or efficacy trends
Sensitivity analyses to check the robustness of the results under different models

A particular focus is on advising on and implementing adaptive study designs that allow flexible adjustment to interim results – e.g. changing the number of cases, adjusting dosages or modifying endpoints. We accompany you through all phases, from methodological planning and communication with the regulatory authorities to implementation in the analysis phase. Our methodological expertise also includes

Multiple test corrections and adjustments for multiple comparisons
Time series analyses, survival time analyses and mixed models
Handling missing data (e.g. imputation techniques according to ICH E9)
Development of validatable models for risk or efficacy assessment

With this broad spectrum, we ensure that your study not only complies with regulatory requirements, but also delivers methodologically sound, convincing results – as a solid basis for approval, market positioning or publication.

Interim analyses & blind data reviews

Interim analyses and blind data reviews are key tools for quality assurance and data-based management of clinical trials. They make it possible to evaluate the course of the study on the basis of preliminary data – without jeopardizing the blinding or compromising the integrity of the final analysis.

We take over the planning, implementation and evaluation of interim analyses for you, which can have the following objectives, among others:

Early assessment of efficacy or safety parameters
Decision on continuation, modification or early termination of the study
Adjustment of study parameters, e.g. number of cases, randomization ratio or dose groups
Review of recruitment process, data quality and protocol compliance

We also carry out structured Blind Data Reviews (BDR) – an essential step in quality assurance before database lock. Thereby:

All available data systematically reviewed without unblinding
Data gaps, inconsistencies and anomalies identified and documented
Queries triggered in a targeted manner and tracked together with data management
Critical variables (e.g. primary endpoints) particularly carefully validated
Plausibility checks and protocol conformity ensured

We create comprehensive interim reports with clear recommendations and a basis for decision-making that can be used both for internal project decisions and for bodies such as data monitoring committees or authorities. We ensure that all assumptions, analysis steps and results are presented transparently – always in accordance with the previously defined analysis plan.

With our interim analyses and blind data reviews, we create certainty before important study decisions are made – neutral, compliant and scientifically sound.

Quality assurance & compliance

Our statistical services comply with strict regulatory requirements such as GCP (Good Clinical Practice), the ICH guidelines (in particular E3 – “Structure and Content of Clinical Study Reports” and E9 – “Statistical Principles for Clinical Trials”) as well as the requirements of the FDA according to 21 CFR Part 11 for electronic records and electronic signatures. We provide you with comprehensive support for the:

Interpretation and practical implementation of regulatory requirements in study design, analysis planning and reporting
Preparation and review of study protocols, SAPs and CSRs with a focus on regulatory compliance
Preparation and submission of regulatory documents, e.g. for EMA, FDA, BfArM or PEI
Preparation of Health Technology Assessment (HTA) dossiers, including the compilation of statistical evidence for cost-benefit assessments
Participation and advice in Data Monitoring Committees (DMCs), including preparation of interim statistical evaluations, security analyses and decision papers

Our experienced statisticians work closely with colleagues from Regulatory Affairs, Medical Writing and our Clinical Data Management to ensure an integrated, consistently traceable data and analysis chain.