Business areas and services
Clinical Data Science
Staburo excels in biostatistics and data science for clinical research.
Clinical Data Science
Biomarkers & Translational Data Science
Data Transparency and Medical Writing
Staburo delivers advanced statistical expertise to pharmaceutical and biotech companies, contract research organisations, and medical device manufacturers.
Clinical Statistics
Experienced biostatisticians support you along the whole drug lifecycle. One principle guides our work: combining methodological precision with a solution-oriented approach tailored to each client’s needs.
Our statistical services comprise:
-
Design of clinical phase I-IV trials
-
Statistical input to study protocols (including the definition of Estimands)
-
Sample Size calculations (including simulations)
-
Development and writing of statistical analysis plans
-
Randomisation (including emergency envelops)
-
Interim Analyses (Unblinded teams if required)
-
PK/PD Analysis: Parameter estimation with Winnonlin/SAS; PD parameter calculation, Immunogenicity data analysis and PopPK Modelling
-
Data Review Meeting support
-
Safety and Data Monitoring Committee (DMC/SMC) support
Advanced Capabilities:
-
Statistical support for Clinical Development Programs
-
Consulting on statistical issues
-
Optimal study design identification support
-
Statistics support in submissions to FDA, EMA and other regulatory agencies
-
Presentations and statistics workshops
Special Statistical Expertise
- Crossover correction in oncology (IPCW, IPTW, IPE, RPSFT methods)
- Advanced Survival Analysis
- Multiple imputation
- Bayesian Methods (e.g. BLRM for dose escalation, Bayesian hierarchical models)
- Adaptive designs
- MCPmod analysis
- (Generalised) Mixed Effects Models
Statistical Programming
Our statistical programming team has contributed to clinical trials across all phases and study types. One principle is the standardisation of programming processes without losing flexibility and creativity to be effective and not only efficient.
Regular trainings on regulatory standards – including CDISC (SDTM, ADaM), ICH, and agency guidelines – guarantee up to date expertise.
Our main goal is generating submission ready deliverables for our clients.
Core Programming Services:
- Visualisation and output programming
- Program validation and quality control
- Implementation of algorithms (SAS macros and R package development)
- Regulatory requirements: CDISC submission packages (DRG, define.xml, ADaM, SDTM); BIMO listings
- Shiny apps
The main programming languages are SAS and R.
Advanced Capabilities:
- Implementation of crossover correction methods in SAS
- PK/PD data analysis (including parameter estimation with WinNonlin/SAS/R, datasets for PK/PD modelling)
- Immunogenicity data analysis
Data Management
Experienced data managers guide you through the setup of data collection environment, integrate multiple data sources, and design databases matching your specific needs.
Flexibility remains central to our data management approach, ensuring tailored solutions for each client. Our team works with in-house EDC solutions or client-preferred systems.
We work mainly with the following EDC systems: Veeva, Viedoc, Medidata RAVE and Zelta.
Core Services:
- Data Management oversight
- Creation of Data Management documentation
- CRF design and build
- Edit Check programming
- User Acceptance Testing
- EDC user access management
- Data cleaning and data review listings
- SAE and External Data Reconciliation
- Medical Coding (MedDRA and WHODrug)
- EDC helpdesk
Advanced Capabilities:
- Consulting and CRO oversight
- ePRO (electronic Patient Reported Outcomes) setup
- IWRT (Interactive Web Response Technology) environment configuration
- External data integration
- Local laboratory ranges management
Health Technology Assessment
Staburo supports clients in the planning phase and conduct of HTAs, as well as in reimbursement of drugs and medical devices.
Staburo has successfully contributed multiple HTA projects that have led to a recognition of additional benefit of our client’s products.
You can find more information on our Statistical Support for Regulatory Submissions under “Expertise“.
Consultation Areas:
- Suitable trial design for comparative effectiveness
-
Selection of surrogate endpoints that can replace clinically relevant endpoints
-
Literature research
-
Dossier writing
-
Crossover-corrections, in-depth QoL analyses, indirect comparisons, and meta-analyses
-
Support for the interaction with HTA bodies such as IQWiG/GBA or NICE
Ready to Collaborate?
Whether you need senior biostatistics support, reliable data science expertise, or strategic guidance for your clinical development programs, our team is here to help.