Clinical Research
On behalf of our partners in academia, healthcare and industry, UCR plans and conducts clinical studies with a focus on quality, efficiency and regulatory compliance.
UCR’s combined expertise in clinical studies and quality registries enables pragmatic clinical studies based on registry data.
UCR provides support throughout all or parts of the study lifecycle, from study design and planning to conduct, close-out, analysis and publication.
UCR offers:
- extensive experience in different types of studies, including randomised studies, registry-based randomised clinical trials (RRCT), clinical trials of medicinal products (including ATMPs) and medical devices, decentralised studies (DCT), observational studies and epidemiological studies
- experience across a wide range of medical areas, including oncology, metabolic diseases, infectious diseases, surgery, orthopaedics, gynaecology and psychiatry, with strong expertise in cardiovascular research
- experience of clinical studies in collaboration with both academia and the pharmaceutical and medical device industries
- experience of conducting studies at local, national and international level
- broad expertise in biostatistics, project management, data management and monitoring
- an established quality management system based on requirements for clinical trials of medicinal products and medical devices
Project management
Strategic and operational management and coordination of clinical studies throughout the study lifecycle, from planning and site initiation to close-out, analysis and reporting.
Data management
Structured data management and system support for data collection, including quality control and preparation of analysis datasets (e.g. REDCap).
Regulatory support and authorities dialogue
Support in ethics and regulatory submissions, safety reporting and regulatory questions in accordance with applicable requirements.
Publication support and medical writing
Support in coordinating and preparing grant applications, scientific articles, reports and publications.
Biostatistics
Advice and practical support in study design, power calculations, randomisation, statistical analysis plans and analysis.
Monitorering
Quality assurance of data and compliance with regulatory requirements, with a focus on patient safety in close collaboration with participating sites.
Clinical Event Adjudication (CEA)
A process for independent medical assessment of clinical events based on predefined criteria.
Contact us
Do you want to discuss a clinical project or collaboration? Contact us for more information.