Services
Statistical
Services Statistische<br>Services learn more
Statistical programming Statistical programming learn more
Statistical
Consulting Statistische<br>Beratung learn more
Outsourcing & insourcing Outsourcing & insourcing learn more

Statistical
services

DATAN is a statistical service provider for pharmaceutical/biotech companies, contract research organizations, universities and institutions.

We are a biostatistics and data science service provider with extensive expertise in the field of clinical research. Our more than 36 years of experience range from the design of clinical studies in phases I-IV, DMC management and interim analyses to data analysis with SAS® and R. High quality standards are ensured by independent validation.

We speak your language

Our particular focus is on the correct interpretation of results and the comprehensible presentation of results. This includes an appropriate graphical representation that presents the results clearly and accurately. We know what you need.

  • Advice on study design
  • Sample size calculation and simulations
  • Contribution to statistical data for the study protocol
  • Review of study protocol and CRF
  • Development of a statistical analysis plan (SAP)
  • ISS/ISE planning
  • Representation at meetings of the regulatory authorities (FDA, EMA, BfArM and others)
  • SAS or R programming and independent validation of statistical results
  • CDISC results (SDTM, ADaM, define.xml files, guide for auditors)
  • CDISC conversion of legacy data
  • Cross-study integration of data, ISS/ISE programming
  • Patient profiles and ad hoc reports
  • Statistical modeling and simulation
  • PK/PD analysis and modeling
  • Management, support and participation in DMC meetings
  • Management of charter development and input to the DMC charter
  • Provision of an independent statistician and/or a DMC member with voting rights
  • Role as an independent data coordination/statistics center
  • Programming and distribution of statistical results for the DMC or interim analyses
  • Statistical reports, also with interactive tables and graphics
  • Clinical study reports (ICH E3 or TransCelerate standards)
  • CDISC and FDA compliant submission packages and documentation
  • Packages with topline and final analysis results
  • DSURs, PSURs
  • Development of manuscripts
  • Publication of study results on EudraCT and clinicaltrials.gov
  • Development of randomization plans
  • Independent randomization services
  • Design of experiments (DoE)
  • Analysis plans
  • Sample size calculation and simulations
  • Statistical analysis and advice on data visualization techniques
  • Statistical evaluation

Quality assurance through the use of a comprehensive library of validated SAS® macros or SAS® program modules and systematic validation: independent review, code review or double programming.

Use of client standards or CDISC standards with ADaM datasets to ensure traceability, reproducibility and compatibility.

Statistical
Programming

DATAN has an experienced team of statistical programmers

We have supported clinical trials in different phases and of different types. Our programming team consists of experienced statistical programmers who have been involved in many studies of different sizes. Our continuous monitoring and evaluation of developments in industry standards, innovations and technologies ensures that we perform sound data analysis. In this way, we ensure that your projects are carried out to the correct standards and are therefore ready for review and submission.

DATAN is geared to your wishes

Depending on the customer's requirements, we provide our services in the customer's IT architecture or on our own systems. DATAN's programmers support our customers in the development and validation of data for clinical study reports and generate results ready for submission.

Statistical programming includes: Analysis of datasets, tables, listings and figures, CDISC mapping (SDTM and ADaM), program validation, biomarker identification.

Highest quality standards through continuous education and training, validated program libraries and industry-standard quality assurance measures.

Data protection and information security comply with the latest recommendations of the BSI and are continuously monitored.

Statistical
Consulting

DATAN is the first choice for biostatistical consulting

We are statistical experts with extensive experience and provide professional and application-oriented advice on any statistical issue. Our statistical consulting services cover issues such as sampling, data collection, data management and finally the appropriate analysis methods.

DATAN knows the needs of its customers

Quality, speed and flexibility are the key parameters for planning complex study designs in close coordination with the customer and implementing them on schedule. We combine our strengths with technology, innovative approaches and in-depth industry expertise. Our goal: to create customized solutions and sustainable added value for your company.

Statistical consulting includes: (complex) modeling and simulations, sample size estimation, specifications for estimates and intercurrent events, dealing with missing data, preparations for audits and inspections, advice on data quality

Extensive knowledge from previous projects and a sound academic education ensures the creation, documentation and implementation of complex consulting projects.

Outsourcing &
insourcing

Cooperation with DATAN increases the flexibility of our customers

DATAN offers the full range of development services to support clients in their research programs. DATAN's clinical biostatistics team provides complete statistical analysis for Phase I-IV studies, including as a preferred vendor if desired. Our experienced biostatisticians provide advice on study design, develop complex statistical analysis plans and assist sponsors with interactions with regulatory authorities. Our group of biostatisticians and statistical programmers have the experience to see a project through from start to finish. We can act as statistical experts for your study or work with your company's internal statistical team to achieve your goals.

Also at our customers' premises on request

DATAN offers biostatistics and statistical programming services in an insourcing model to support clinical, health economic and patient-related projects on a very flexible basis. Our services are of interest to pharmaceutical, medical device and biotech companies. We support your biostatistics and programming department and also have experience as a neutral "second opinion" regarding your biostatistics providers.

Our insourcing services include providing additional resources to support your biostatistics and clinical programming department, expert biostatistical consulting, development of customized biostatistical applications, conversion of clinical trial data to CDISC standards and biostatistical analysis services for clinical trials (also as preferred vendor).

We always work according to the latest standards, the specifications of our clients, laws and the relevant guidelines of the approval authorities.