We deliver quality on time!

BiTrial is a full-service contract research organization in Central and Eastern Europe with a headquarter in Budapest, Hungary.

We provide a wide range of clinical trial expertise for both medical device developers and pharmaceutical companies to facilitate our partners’ decision making and significantly reduce their product development time.

Services

BiTrial has experienced and motivated team members dedicated to help our clients in the following areas of clinical research:

Medical writing:

Site selection, feasibility and study start-up

Confidentiality Agreement (CDA) development
Feasibility Questionnaire (FQ) development
BiTrial Site Database for easy site selection
Conducting complete feasibility study (obtaining executed CDAs and FQs)
Feasibility Report writing
Coordination of investigator meetings
Clinical Trial Agreement execution with the selected sites
Site Initiation Visit (SIV) conduction

Regulatory and Ethics Approval

Clinical monitoring and project management

Developing plans and timelines for research projects
Initiation and routine monitoring of investigational sites
Site and patient recruitment support
Training and education of sites
Site payment management
Remote and on-site clinical trial monitoring
Partial and full source data verification (Risk-based monitoring)
Site closure activities

Biostatistics

Study design (including group sequential and adaptive study designs)
Sample size calculations
Conducting simulation studies
Randomization and study blinding schemes
Writing the Statistical Analysis Plan (SAP)
Creating statistical tables, data listing and figures for clinical study reports

Data management

Paper CRF and eCRF design and planning
Development of CRF completion guidelines
Development of Data Management Plan
Database development, validation, and maintenance
Data edit check planning and management
Data validation and query management
Medical coding
Status report preparation
Data Monitoring Committee services

Quality assurance

Safety and medical management

Additional activities

Assistance in marketing authorization (DCP, MRP, RSM, national)
Patient recruitment (via Internet and advertising)
Patient travel reimbursement management
Translation services
Record management services
CRA outsourcing

Why BiTrial?

BiTrial has a long-term experience in conducting clinical trials in a broad range of indications.
Our colleagues are highly experienced in clinical monitoring and experts in local regulations for clinical trials.

We provide a wide spectrum of clinical research solutions across Europe.

Our 12 months basic monitoring course has a carefully developed curriculum containing both practical and theoretical courses for our CRA trainee colleagues. Our yearly courses of advanced monitoring focus on the novelties of the pharmaceutical and medical device industries.

The high level of education of our staff and our expertise in clinical trials makes BiTrial a cost-effective and reliable partner.

BiTrial combines the advantages of a regional CRO – cost effectiveness, local knowledge, personalized service, and flexibility – with the expertise and understanding that comes from a history of managing global clinical trials at the highest standards of quality.

We have successfully conducted clinical trials with innovative designs like Bayesian designs, group sequential designs and adaptive designs.