Overview of our clinical study services
To accommodate your unique study requirements, we offer our services as complete packages or as individual solutions.
Scientific, medical, and regulatory expertise
- Planning of study design (including early phase trials)
- Definition of outcome parameter and endpoints (including surrogate parameters of cardiovascular disease e.g. vascular phenotyping, imaging, and blood biomarkers)
- Incorporation of the planned study into the clinical development strategy
- Scientific review of your study concept
- Multidisciplinary medical research approach, including patient representatives.
Project
management
- Planning of the clinical study (timelines, tasks, budget)
- Project oversight (delivery of regular status reports)
- Communication with stakeholders
- Supplier management
- Qualification and selection of study sites
- Management of contracts
- Creation and maintenance of the trial master file
Regulatory
Affairs
- Submission to and ongoing communication with ethics committees and national competent authorities
- Review of existing documents for compliance with legal or regulatory requirements
Biostatistics
- Sample size calculation
- Statistical planning
- Creation of Statistical Analysis Plans
- Statistical programming
- Conduct of Statistical Analysis
Data management
- Planning of data capture (Design and creation of paper-based and electronic case report forms)
- Creation of data management plans
- Establishment and validation of the database
- Programming of plausibility and consistency checks
- Conducting data cleaning and query management
- Definition and management of protocol deviations
- Preparation of data for statistical analysis
Medical writing
- Designing and writing the study protocol
- Designing and writing the patient informed consent form
- Writing the final study report
- Systematic literature searches
- Publications
Get in touch with us
Are you in need of a competent research partner for your project idea?
Are you planning a clinical trial? Are you developing a medical device, medical product or medical image processing tool?