Clinical data analysis for drug development

Life Science

Continuous and rapid drug development is the key to sustained success in the Life Science 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.

Exploit the clinical data potential
Nowadays R&D pharmaceutical companies want to leverage the potential of their clinical data by enriching the integrated data with further data sources (RWE, wearables, etc.) and applying new technologies and new methodologies such as AI to gain new insights and find new evidences.

The challenge
What sounds feasible at first is a formidable challenge and requires several parties as research, business, regulatory, data science, software development to work closely together and to fully dovetail the necessary expertise from different domains.Analyse klinischer Studien

CRO+ is our differentiator
We support you with longtime 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. HMS is the one-stop-shop provider combining and dovetailing all necessary skillsets to leverage the data potential with AI.

Our service portfolio

Our service portfolio covers the full range of solution development in the regulated environment (GxP/ MDR / IVDR) and non-regulated environment of the life science sector.

Whether on-prem or in the cloud, we can support you with any type of software platform.

  • De-identification / anonymisation / pseudonymisation of patient data
  • Automated harmonisation and integration of different clinical data types and formats
  • Construction of Analytical Base Tables (ABT) for the application of Machine Learning
  • Pooling of study data
  • SAS macro development and validation
  • SAS, Python and R programming
  • Statistical consulting
  • Mathematical modelling
  • Exploration and analysis of secondary clinical data and preclinical data
    • Medical image recognition (Deep Learning)
    • Prediction of disease progression (Machine Learning)
  • Development of assistive systems for process automation and optimisation of workflows in data analysis
  • Development and validation of computer-aided systems (CSV / GAMP5)
  • Design and implementation of Statistical Computing Environments (SCE) in the Cloud and On-prem
  • Risk-based implementation and validation of R packages
  • Migration of SAS environments
  • Consulting and concepts for data governance in the cloud
  • Contract development of medical device software and software as medical device (IEC 62304)

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
  • Regulanet (Regulatory and Market Access Support)

We also maintain long-term partnerships with

HMS Analytics Use Case Solution

Planning and analysis of clinical trials on a validated R environment at medac.

Show Use Case
What you can count on at HMS

Experts for the pharmaceutical industry

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

Data analysis realised flexibly

We understand your requirements and implement them on your or our systems according to your needs.

Cross-disciplinary expertise

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

Your contact person

We’re always there for you!

HMS Team Nicolai Haag
Nicolai Haag
Head of Life Science