SERVICES

Aicros offers the following services for medical device, pharmaceutical and biotech companies:

  • Medical support
    E.g. we write your study protocols, informed consent forms and clinical study reports
  • Regulatory Affairs
    E.g. we obtain the approvals for your clinical studies from the Ethics Committees and Competent Authorities
  • Clinical Phase II-IV Services
    International Project Management – Clinical Monitoring – Remote Monitoring – Electronic Data Capture (EDC) - Clinical Trial Management System (CTMS) - Interactive Response Technology (IRT) – electronic Trial Master File (e-TMF)- Translations- Study Drug and Material Management - Quality Risk Management Service (QRM)
  • Non-Interventional Trials
    Epidemiology and cohort studies – Observational studies – Case control studies – Registries - Post-market surveillance studies with CE marked Medical Devices
  • Biometrics
    Data Management and Biostatistics – Data Cleaning– Randomization – Sample Size Calculation - CDISC
  • Quality Assurance Services
    Consultancy – Investigational Site Audits – System Audits – Risk Analysis – Support of Establishment of Quality Management or Quality Risk Management System
  • Training
    E.g. F2F Training at investigational Sites and at companies, certified online training in ICH GCP, the national regulations of many EU countries and ISO14155