Services - AICROS Association of International CROs
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Services

Personalized services globally by local experts

 

AICROS has a long-term partnering approach with decades of experience and provides all services needed to successfully run a clinical study.

Medical Writing

  • Clinical Study Protocol
  • Clinical Investigational Plan
  • Clinical Evaluation of Medical Devices
  • Patient Information/Informed Consent Form
  • Investigator‘s Brochure
  • Investigational Medicinal Product Dossier
  • Clinical Study Report

Clinical Operations

  • Feasibility Studies
  • Site Selection
  • Contract and finance management
  • Clinical Monitoring including risk-based and remote monitoring
  • Project Management of national and international clinical studies
  • Training for CRAs and Investigators

Regulatory Affairs

  • Full Regulatory Affairs Support
  • Dossier Pre-submission Assessment and Gap Analysis
  • Competent Authority and Ethics Committee submissions
  • Full medicinal product dossier development Marketing Authorization Applications
  • Full post-authorization support
  • Consulting services

Pharmacovigilance

  • Full Pharmacovigilance Support
  • Clinical safety services, supported with fully E2B and CFR21 compliant safety database
  • Medical monitoring 24/7 services
  • EU Qualified Person for Pharmacovigilance Service
  • Full post-authorization support including local safety services

Data Management

  • Set-up of CRFs
  • Set-up and validation of clinical data base
  • Statistical programming
  • Medical coding
  • Data cleaning
  • Data mapping (e.g. CDISC)

Biostatistics

  • Biostatistical Analysis (Interim or Final)
  • Centralized statistical monitoring
  • Randomization
  • Simple Size Calculation
  • Statistical Consultancy and Planning (e.g. preparing SAP)

Quality Assurance

  • Consultancy
  • Investigational Site Audits
  • System Audits
  • Risk Analysis
  • Support for Establishment of Quality Management or Quality Risk Management System
  • GCP/GVP audits
Take advantage of our expertise. Contact us for tailor-made solutions for your clinical studies