Clinical data analysis for drug development

Statistical programming and biostatistics

Continuous and rapid drug development is the key to sustained success in the pharmaceutical industry. Since pharmaceutical companies are subject to strict regulatory requirements, the reliable and secure analysis of clinical data plays a key role in this development process. At the same time, the costs and time required for the final approval decision need to be kept as low as possible.

With the help of our experts at HMS, you can successfully achieve your goals. We support you with more than 30 years of experience in clinical research and development and will find the right solution for each of your challenges. Take advantage of the expertise of our statistical programmers and biostatisticians, who have successfully completed a wide range of clinical data science projects.

Analysis of clinical studies

Our services

  • Analysis of clinical studies (Phase I-IV, observational study) and preclinical data
    Data integration
  • CDISC services (SDTM/ADaM/Define-XML)
  • eSubmission (preparation of evaluations for registration dossiers and answering questions from authorities)
  • Regulatory support ( with respect to regulatory authorities such as FDA, PMDA, EMA, BfArM)
  • De-identification of data
  • Exploratory data analysis
  • Statistical support
  • Development of standard macros
  • Use of data analysis software such as SAS, R, JMP
  • Training courses

Extensive network

HMS cooperates with leading industrial companies and associations:

  • PhUSE  (Pharmaceutical Users Software Exchange) – a non-profit platform for the exchange of experience in statistical programming, biostatistics, data management and software development in the clinical field
  • CDISC (Clinical Data Interchange Standards Consortium) – a worldwide data standard for clinical research
  • IBS (Internationale Biometrische Gesellschaft) – an international association for the development and application of statistical and mathematical theories and methods in the life sciences
  • KSFE (Conference of SAS Users in Research and Development)

We also maintain long-term partnerships with

Our long-standing customer relationships are founded on trust and teamwork.”Beate Hientzsch, Head of Statistical Programming and Biostatistics at HMS

What you can count on at HMS

Specialists for the pharmaceutical industry

For clinical study evaluations, we provide you with highly qualified biostatisticians and statistical programmers who are very familiar with the special requirements of the pharmaceutical industry and its regulations.

Flexibly implemented data analysis

We understand your requirements and implement them on your or our systems in line with your needs.

Cross-disciplinary expertise

Our services are unique because we combine different disciplines such as business intelligence, machine learning and software engineering and deploy them profitably to your benefit.

Your contact person

We’re always there for you!

Beate Hientzsch
Head of Statistical Programming and Biostatistics