Clinical Research

  • Clinical research, both domestic and international
  • Clinical trials, phases I to IV (also performed in our medical centre)
  • Protocol and CRF preparation, logistics for ethics commission and official agencies
  • Literature search and processing
  • Recruiting and selection of (primary) investigators
  • Conducting of investigator meetings
  • Recruiting and establishment of central laboratories
  • Personal and online monitoring, auditing, quality assurance
  • Budget administration, accounting
  • Data management, biometrics and statistics
  • Reports, dossiers, scientific brochures, publications
  • Side effect cases, safety projects
  • Registration, expert reports
  • Preparation and monitoring of Standard Operating Procedures
  • Consulting, training, seminars

Service Overview
- Clinical Research
- International Marketing
- Standards
Our

EMEA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · CRO – Clinical Research Organisation · CRO – Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection