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Services

BiTrial has experienced and highly skilled and motivated team
members dedicated to the following functional areas:.

Protocol writing – Medical Advise

  • Each writer is a graduate-level life science scholar, many of them holding faculty appointments at local universities. They enhance their scientific and technical expertise through continuing medical education and study-specific trainings.
  • Consultation with local Authorities to obtain their preliminary opinion before protocol finalization

Site selection and feasibility

On-time site enrollment with choosing BiTrial site selection and feasibility support.
Initial analysis includes:

  • Country ranges, site performance estimates
  • Number of reliable sites by country
  • Expected enrollment rates based on preliminary information

Initiation of Clinical Trials

  • Developing plans and timelines 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

Statistical analysis

  • Writing the Study Protocol (SP) and the Statistical Analysis Plan (SAP)
  • Database Design, Development and Validation
  • Data Collection and Database Maintenance
  • External Electronic Data Integration
  • Database Lock and Final Data Transfer
  • Statistical Analysis and Final Study Report

Conducting and closing of Clinical Trials

  • Investigator’s Meeting Organization
  • Initiation Visit, Monitoring, Adverse Event Reporting
  • Site closure, Query resolution
  • Data processing, Coding, Statistical Analysis

Regulatory and Ethics Approval

Full-scale regulatory and ethics approval procedures including Protocol Amendments

Additional activities

  • Study drug storage and destruction
  • Marketing authorisation (DCP, MRP, RSM, national)
  • Promoting medication for governmental drug price support
  • Product launch – sales and marketing services – sales force
  • Patient recruitment (via Internet and advertising)
  • Patient travel reimbursement
  • Database of Investigators
  • Translation services

Summary Reports

Because of our wide range of extensive experience in nearly every therapeutic area, from Oncology to Ophthalmology, we also provide a comprehensive knowledge of every pharmaceutical, medical device or commercialization document type.

We understand and deliver the rigorous requirements needed for medical writing and market approval.

Advanced electronic management

Professional use of different IVRS and electronic CRF systems

Hungarian Clinical
Trial Cluster

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BiTrial Clinical Research is charter member of the first Hungarian Clinical Study Cluster (HCSC) established with the purpose of developing close relationships between participant members in order to improve quality and capacity in all aspects of drug development and clinical trial conditions

Clinical Research
Coordination

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Our strategic partner, Clinical Research Coordination Ltd., is the market leader Study Management Organization (SMO) in Hungary. Clinical Research Coordination Ltd. is present in about 13 hospitals and provides a unique support to sponsors and investigational sites by ensuring:

CE-EU Region

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Our strategic partner, Clinical Research Coordination Ltd., is the market leader Study Management Organization (SMO) in Hungary. Clinical Research Coordination Ltd. is present in about 13 hospitals and provides a unique support to sponsors and investigational sites by ensuring:

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BiTrial Clinical Research is a privately owned mid-sized Clinical Research
Organization (CRO), based in Central and Eastern Europe with
a headquarter in Budapest, Hungary.