Protocol writing – Medical Advise
Statistical analysis
Site selection and feasibility
Initiation of Clinical Trials
- Developing plans for research projects
- Feasibility analysis of the project
- Identification of suitable investigators and sites from our database
- Protocol development
- Data Form compilation, typographic design
- Patient Information Sheet and Informed Consent compilation and translation
- Translation and adaptation of contracts and insurances
Regulatory and Ethics Approval
- Full-scale regulatory and ethics approval procedures including Protocol Amendment
Conducting and closing of trial
- Investigator's Meeting Organization
- Initiation Visit, Monitoring, Adverse Event Reporting
- Site closure, Query resolution
- Data processing, Coding, Statistical Analysis
English to Hungarian, Hungarian to English translation of clinical research technical texts
Summary Reports
Advanced electronic management
- Professional use of different IVRS and electronic CRF systems
Additional activities
- Study drug storage and destruction
- Patient recruitment (via Internet and advertising)
- Patient travel reimbursement
- Database of Investigators