"Literary requirements"

Our highly qualified and experienced specialists will prepare  reports or translations. The following documents can be prepared

  • Study protocols
  • (Electronic) Case Report Forms
  • Regulatory approvals
  • Expert reports
  • Study reports
  • Periodic Safety Update reports
  • Product Characteristics
  • Investigator brochures
  • Investigator contracts
  • Publications/articles
  • Lecture manuscripts
  • PR Material
  • Editorial editing

Clinical Trial Management
(e)CRF-Development
Patient Recruitment
On-site/Off-site Monitoring
Economic Studies
Biometrics
Budget Management
Product Safety
Medical Writing
Our experience ...

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