MAGYAR
CLINICAL STUDIES
The company’s profile includes the comprehensive compilation of clinical trial documents, managing clinical trial applications and monitoring clinical trials of any phase within the European Union, as well as outside of it.
Preparing clinical studies
- Clinical study feasibility assessment and analysis
- Investigational site selection
- Compilation of the clinical study protocol
- Editing and printing the case report form
- Compilation, translation of patient information leaflets and informed consent forms
- Execution of contracts, required insurances, translation and adaptation
Obtaining ethical and regulatory authority approvals
- Obtaining complete ethical- (both local and central) and regulatory authority approvals, including protocol amendments, if applicable
Complete management and closure of the study
- Organizing “investigators’ meeting”
- All reports in relation to the site initiation visit, clinical study monitoring and adverse events (AE, SAE)
- Closure of investigational sites, managing upcoming issues
- Data management, coding and statistical analysis
- Translation of clinical and research documents
- Compilation of summary reports
- Professional development and management of electronic CRFs
CO-ORDINATION OF CLINICAL STUDIES
Preparing clinical studies
- Defining, identifying patient cohorts
- Estimating project workload and costs
- Preparing the investigational sites
Communication with ethics
committees and regulatory authorities
- Coordinating AE / SAE reports
- Checking and documenting reporting requirements
Conducting clinical studies
- Organizing patient visits
- Cataloging data (source data, etc.)
- Checking CRFs (both in electronic and paper form)
- Checking, maintaining “Investigator Site Files”
- Communication with external service providers (laboratories, X-ray, CT, etc.)
- Cross-functional fine-tuning of the project