Clinical research

A flexible and trustworthy contractor, ClinTrial Audit Ltd. offers a wide range of clinical research services to Hungarian and international CRO's, pharmaceutical companies, and hospitals, by assigning to the job highly trained contract monitors (CRA's) with clinical trials experience.

ClinTrial Audit's services are comprehensive and cover all phases of the clinical trial process. ClinTrial Audit conducts all clinical monitoring and related activities in accordance with GCP standards and applicable law.

Clinical Studies

Phase I-IV domestic and multinational trials

Study design, protocol development, case report form design and printing
Site and investigator selection and recruitment
Regulatory and ethical approval procurement, preparation and review of regulatory submissions, interaction with regulatory agency
Continuous liaison with investigators
Management of patient recruitment
Site management and monitoring based on Standard Operating Procedures and study-specific check-lists (site initiation, regular monitoring visits, source data verification, monitoring visit reports, adverse event reports, site closure visits)
Data management services and trial administration (validated data entry, database design, data upload, computerised error detection and data checking, data queries, filing system design and implementation)
Electronic information systems (investigator’s information, data handling guidelines, online status reports)
Statistical evaluation
Interim status report, final report and media presentation

Our colleagues have clinical research experience in a wide range of therapeutic areas including:

cardiovascular diseases
diabetology
infectious diseases
paediatrics
respiratory tract diseases
neurology
oncology
psychiatry
vaccines

Pharmacovigilance

Design, implementation and maintenance of drug safety reporting systems
GCP compliance monitoring of all aspects related to trial drug

Biostatistical services

We assign trained biostatisticians with pharmaceutical trial experience to clinical trial design and data analysis.

Sample size estimation
Analysis plans
Statistical programming
Statistical analysis using multilevel Cox-regression models, general linear models, etc.
Data presentation (tables, graphs, etc.)
Final report writing in accordance with EMEA regulations

Medical writing

Study protocol design
Study reports, literature reviews, regulatory approval documentation, presentations, info leaflets, brochures, meta-analyses
Clinical expert reports
Promotional materials

Quality assurance

Design and implementation of quality assurance systems
Clinical trial audit (system audit, “compliance-to-system” audit, trial data or report audit, “for cause” or directed audit)
GCP quality assurance and quality control seminars
Planning and writing of SOP’s

Key research areas

Our colleagues are experienced in clinical research areas including: