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.
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.
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.
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.
Many double-blind clinical trials run over a long period of time. It is therefore very important to regularly monitor the safety of the subjects and the conduct of the trial during this phase, especially in trials testing a new active substance. For this reason, a group of independent experts, known as the Data Monitoring Committee (DMC), who may not be employees of the sponsor, are unblinded. The DMC monitors the conduct of the study, usually consists of at least two medical experts and a statistician, and meets at regular intervals to decide whether the continuation of the study is justified. DMC members must evaluate all safety data and, if applicable, efficacy endpoints.
During the course of a study, the DMC may make recommendations to the study management regarding the further course of the study (e.g., stopping a treatment group, stopping the entire study, introducing additional visits) in order to ensure the successful completion of the study for all stakeholders, subjects, and the sponsor.
DATAN acts as an independent SAC in this process for Phase I to IV studies, which means that DATAN creates unblinded tables, figures, and listings (TFLs) of the current data from an ongoing study.
Real-world evidence (RWE) refers to clinical insights derived from the analysis of real-world data (RWD)—that is, data generated outside of controlled clinical trials in the context of real-world healthcare practice. It can complement the results of randomized trials and enables the assessment of the efficacy and safety of therapies under real-world conditions and over long periods of time. This is particularly true for populations that could not be studied in clinical trials. Regulatory agencies such as the FDA and the EMA increasingly recognize the value of RWE for regulatory decisions and
now also use their own analyses for this purpose. In combination with clinical trial data, RWE enables more up-to-date, comprehensive, and patient-centered approval and reimbursement decisions.
RWD is derived from a wide variety of sources, including electronic health records (EHR/EMR), medical registries, billing and prescription databases, patient-generated data, and data from wearables and mobile devices. Combining these sources via appropriate interfaces (interoperability) enables a holistic view of patient care and provides insights that cannot be captured in traditional clinical trials or commercial non-interventional studies.
The EHDS establishes an EU-wide infrastructure and legal framework for the sharing of health data, particularly for the secondary use of health data (HealthData@EU): Health data can be used for important purposes—such as scientific research, health resource planning, and the assessment of the safety of new drugs or treatment methods—while ensuring data protection.
Data from EU member states, including Germany, is fed into the EHDS: The data-holding agencies—such as the Health Research Data Center (FDZ) at the BfArM, the Health Research Data Portal (FDPG), or individual medical registries—decide, upon request, whether access to the requested data can be granted.
As a specialized biostatistics service provider, we support you in the planning, conduct, and analysis of real-world studies—from selecting the appropriate data source and preparing the data to regulatory submission.
Our range of services includes:
The use of RWE offers a number of key advantages over traditional study designs:
In addition, RWE provides further evidence for regulatory and
reimbursement decisions and supports comparative
effectiveness research.
Whether it’s regulatory support, reimbursement strategy, or generating scientific insights—we’ll guide you every step of the way, from selecting the data source and designing the study to the final report.
Contact us to find out how we can help make your RWD project a success.
