Working with Us
Expertise & Solutions
We support you and your projects with flexible solutions.
Expertise & Solutions
Quality
Staburo Academy
Flexible Support and Solutions
Our expertise covers the key aspects of clinical data science and research.
This includes clinical statistics, statistical programming, data management, biomarker and translational data analyses, all data transparency activities, as well as support for medical writing and reporting.
With broad experience across therapeutic areas, we bring practical insight and scientific precision to every project.
We are trusted partner of pharmaceutical and biotech companies, academic institutions, CROs and medical device companies. Our international clients are small startups, SMEs as well as big pharma companies.
Supported by our robust quality framework, we deliver reliable, accurate, and audit-ready data that supports patient safety, data privacy and compliance.
Consulting
Staburo provides expert consulting for strategic, scientific and operational questions across clinical development.
Our team supports clients in trial design, data strategy, sample size planning, analysis approaches, regulatory interactions, submission preparation, vendor oversight, and the interpretation of clinical, biomarker and translational data.
This model is suitable when you need senior expertise, an independent second opinion, support in complex methodological discussions, or neutral oversight of internal or external activities.
Insourcing
Staburo experts support your teams directly within your established environment.
In an insourcing model, our team works according to your SOPs, processes, templates, systems and project standards. This allows us to support specific tasks, work peaks, defined processes or long-term resource needs while integrating smoothly into your organisation.
Typical areas include clinical statistics, statistical programming, data management, CDISC-related work, biomarker and translational analyses, data transparency, medical writing, quality control and document review.
Outsourcing
Staburo offers full outsourcing of defined data science activities, work packages, studies or larger project responsibilities.
In this model, Staburo takes responsibility for the agreed scope of work and delivers the project using Staburo’s quality framework, SOPs, processes and systems, unless otherwise agreed.
Our outsourcing services can cover the end-to-end clinical data process, from data capture and data management to analysis, interpretation, reporting and submission-ready deliverables.
We manage the work from planning to delivery, with clear responsibilities, reliable communication and a strong focus on quality, timelines and regulatory expectations.
Therapeutic Areas
Staburo has worked in many different therapeutic areas:
- Oncology – strong focus
- Respiratory – many projects as preferred provider
- Vaccines – very experienced
- Allergology
- Cardiovascular
- Central nervous system
- Dentistry
- Dermatology
- Gastroenterology
- Gynaecology
- Haematology
- Immunology
- Infectious diseases
- Metabolic
- Ophthalmology
- Pneumology
- Surgery
Study Expertise
Along the entire drug development lifecycle, from pre-clinical to post-marketing studies, we have experience with many different study types:
- Ascending and repeated dose studies
- Bioavailability and bioequivalence studies
- Drug interaction studies
- Trials with Up/Down Titration
- Human ADME trials
- Renal/Hepatic impairment studies
- Dose finding (oncology and non-oncology)
- Vaccine trials
- Biosimilar trials
- Confirmatory RCTs
- Investigator Initiated Trials
- Non-interventional studies (PMS, PASS)
- Health Economics Outcomes Research (HEOR)
- Medical Device studies
Support for Regulatory Submissions
Staburo supports you with regulatory submissions, e.g.:
- Preparation of submission dossiers and other submission documents for FDA, EMA, Health Canada and other authorities
- Preparation/input to HTA appraisals (e.g. NICE and IQWiG)
- Agency interactions
- Clinical Overview (CO)
- Integrated Summaries of Effectiveness (ISE)
- Integrated Summaries of Safety (ISS)
- Statistical expert reports
- Investigator’s Brochure (IB)
- Safety and pharmacovigilance reports like PBRER, DSUR, RMP
- Literature research
- HTA dossier writing
Project Experience
Staburo’s experience with a broad range of clients enables us to quickly adapt to new projects and requests. We know the standard processes in big pharma, CROs, and biotech or medical device companies.
We bring this experience to your project and can adapt quickly to different environments. Our employees are familiar with many different infrastructures and software platforms.
Communication
We believe in close and transparent communication. Before, during, and after a project, a very close information exchange is absolutely essential in order to keep everyone up-to-date and to ensure a high and consistent level of quality.
Your team will have a dedicated point of contact to ensure efficient communication and clear responsibilities throughout the project.
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.