Clinical studies and registers
In the field of clinical studies (clinical evaluation) and registers we are able to ensure complete service and also individual activities.
We offer:
- monitoring of clinical studies
- postmarketing support
- leading of clinical registers (non-intervention evaluation)
- services in the other fields of biomedicine research
Partial activities:
Project management
- ensuring complete organisation for projects
Medical writing
- plan and protocol development
- information for patients and informed consent
- creation of questionnaires and diaries
- formulation of running and final reports
Communication
- with regulatory authorities (SÚKL)
- with ethical committees
- with participating subjects
Monitoring
- screening, initiatory and running visits
- monitor´s running and general reports
Data management - written and electronic data processing
- creation of reports of evaluation subjects (CRF)
- database ensuring
- data digitalisation and validation
- coding
Education:
- individual consultations
- training of collectives
- preparation of educational materials
Our priorities:
Flexibility
- individualisation of an offer according to requirements and possibilities of our partners
Ensuring and control of quality
- emphasis on correct clinical praxis
- to process according to the standard operation processes (SOP)
Legislative and ethical clarity
- projects under the control of regulation authorities and ethical committees
- ensuring of personal data protection
Scientific evaluation of projects
- we are in cooperation with university workplaces