Data management

Data management is a key element of any clinical trial. Appropriate data management is critical in providing valuable and solid data. We manage data via our subcontracted vendor company, while fully complying with the GDPR regulations. Appropriate data management is critical in providing valuable and solid data. We manage data via our subcontracted vendor company.

  • Biostatistics
    • Study design
    • Adaptive design
    • Analysis and endpoint strategies
    • Sample size estimation
    • Planning the statistical part of the Protocol
    • Statistical Analysis Plan
    • Randomization
    • IWRS
    • Statistical analysis and Report
    • Statistical consulting
    • Data mining
  • Data Management
    • Data Management Plan
    • Data Cleaning Plan
    • eCRF/CRF design, database development and validation
    • Data processing (entering – including double data entry, cleaning, transforming)
    • Query management
    • MedDRA coding
    • Legacy data to CDISC SDTM format transformation
    • Archiving

More Services

Site & Investigator contract negotiation

We support our clients in budget development and negotiation and in the process of contracting investigational sites as well as investigators.

  • Negotiating per-patient fee with site staff
  • Customizing contract templates for each participant (institute, principal investigator, sub-investigator, study coordinator, etc.)
  • Negotiating contracts
  • Supporting contract signature process

More Services

Regulatory services

To meet our customer needs, we assist them in defining the study type (based on the type of investigational product and interventions), discuss the planned submission strategy with the competent authority, complete documents essential for submission to the relevant authorities and the ethics committee, fill out the application documents as well as ensure due diligence of the entire process in order to obtain the approval for the clinical trial conduct within the time frames specified by law.

  • Consultation with the competent regulatory authority, discussion of planned submissions
  • Preparation, review, adaptation and translation of submission documents
  • Obtaining regulatory approval as well as positive opinion of Central Ethic Committee
  • Notification of local ethics committees

More Services

Study feasibility

We check thoroughly the feasibility of any kind of clinical trial in Hungary. Our extensive experience and a vast network of investigators help us to assess the real possibility of study sites to recruit patients.

  • Assisting the client in defining the target group of potential investigators
  • Customizing a feasibility questionnaire for the planned project
  • Conducting a feasibility study
  • Assessing, reporting the results

More Services

Medical writing

As a company dedicated to comprehensive planning and organization of clinical trials, we offer preparing documentation that is essential to conduct clinical research trials. We offer flexible solutions, working with experienced medical writers in various therapeutic areas.

  • Clinical study protocol
  • Monitoring plan
  • Study operational manual
  • Case Report Form
  • Patient Information Sheet
  • Informed Consent Form
  • Other patient related documents: patient diary, patient emergency card, etc.
  • Investigator’s Brochure
  • IMPD
  • Final report

More Services

Overall Clinical Trial Management

We are proud to have highly qualified project managers and clinical research associates with university degrees in medical and life sciences. Our colleagues are continuously trained, up-to-date in local regulations and strictly adhering to the deadlines.

  • Project planning, tracking and reporting
  • Pro-active development of project-focused risk and mitigation strategies
  • Overall project supervision
  • Regular project meetings/teleconferences to review/plan the project scope, assumptions, timelines and activities
  • Primary contact with client/sites/vendors
  • Focused timelines and budget management
  • Preparation of weekly/monthly/quarterly status reports
  • Vendor management
  • Site payment management
  • Organization of investigators’ meetings
  • Initiation and activation of study sites
  • Remote monitoring
  • Risk-based monitoring
  • Regular site monitoring
  • Medical monitoring
  • Pharmacovigilance
  • Closing of study sites

More Services