Datan

Datan Analytics GmbH is a full-service statistical consulting and data science partner headquartered in Münster, Germany, with over 35 years of experience serving the pharmaceutical and life sciences industries. The company specializes in analyzing extensive and complex datasets, delivering actionable results from large data volumes to support critical decisions across the entire drug development lifecycle. Datan's highly qualified team works with pharmaceutical companies, biotech firms, contract research organizations, universities, and research institutions, combining flexibility, professionalism, and rigorous quality standards.

With more than 500 successfully completed projects spanning all phases of clinical development (Phase I–IV) and a broad range of therapeutic areas, Datan has established a strong track record in biostatistics, statistical programming, DMC management, and real-world evidence generation. The team has collectively supported over one million patients and generated more than 6 TB of data, conducting thousands of meetings both domestically and internationally.

Core Service Areas

• Statistical Consulting: Expert advice on all statistical matters, including study design, sample size calculation, simulations, contribution to study protocols, review of protocols and CRFs, development of Statistical Analysis Plans (SAPs), ISS/ISE planning, and representation at regulatory authority meetings including FDA, EMA, and BfArM.
• Statistical Programming: SAS® and R programming with independent validation of statistical results; CDISC-compliant outputs including SDTM, ADaM, and define.xml files; CDISC conversion of legacy data; cross-study data integration for ISS/ISE; patient profiles; and ad hoc reports.
• DMC Management Services: Independent statistical services for Data Monitoring Committees (DMC/DSMB), including management and support of DMC meetings, charter development, provision of an independent statistician or voting DMC member, role as an independent data coordination and statistics center, and programming and distribution of statistical results for interim analyses.
• Real-World Data and Real-World Evidence: Generation of insights from clinical practice to support evidence-based decisions throughout the entire drug lifecycle.

Adaptive Study Design and Advanced Methodology

• Model-Based Approaches: Fully Bayesian, adaptive dose escalation for monotherapies and combination therapies, incorporating preclinical or existing historical data.
• Dose Optimization: Advanced methods to identify optimal dosing strategies, overcoming the limitations of conventional designs such as the 3+3 design to significantly increase success rates.
• Statistical Modeling and Simulation: Support from statistical experts including PK/PD analysis and modeling.

Statistical Reports and Regulatory Submissions

• Clinical study reports prepared to ICH E3 or TransCelerate standards.
• CDISC- and FDA-compliant submission packages and documentation.
• Interactive statistical tables and graphics, topline and final analysis result packages.
• DSURs and PSURs preparation.
• Manuscript development and publication of study results on EudraCT and clinicaltrials.gov.

Additional Statistical Services

• Randomization: Development of randomization plans and provision of independent randomization services.
• Non-Clinical Statistics: Design of experiments (DoE), analysis plans, sample size calculation and simulations, statistical analysis, data visualization advice, and statistical evaluation.

Quality Assurance and Standards

• Comprehensive library of validated SAS® macros and program modules with systematic validation processes including independent review, code review, and double programming.
• Use of client-specific or CDISC standards with ADaM datasets to ensure traceability, reproducibility, and regulatory compatibility.
• Particular emphasis on correct interpretation of results and clear, accurate graphical presentation of findings.

Datan Analytics also offers its DATAN Analytics AI+ platform, designed to accelerate data analysis workflows from days to hours. With a foundation built on decades of pharmaceutical and clinical research expertise, Datan continues to be a trusted long-term partner for statistical services across the life sciences sector.