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?

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