We realize your national and international clinical studies
(Phase I-IV / NIS) according to AMG / MPG and ICH-GCP.

 

Project Management

  • Study design and protocol development
  • Feasibility analysis incl. screening of sites for national and international studies.
  • Selection and recruiting of sites.
  • Submission to authorities (BfArM/PEI) and ethics committee.
  • Federal Office for Radiation Protection (BfS)
  • Contract Management, Payment Management, investigator fees

Medical Writing

  • Protocols & Amendments
  • Study Reports according ICH E3
  • Peer-reviewed publications and posters
  • Observation sheets
  • Patient related documents: Development of Informed Consent Forms (ICF) and questionnaires.
  • Trial relevant translations

 

Monitoring

  • Onsite-Monitoring, Remote-Monitoring
  • Pre-Trial-Assessment
  • Site Initiation
  • Site Monitoring
  • Close Out

Quality Management

  • SOP-generation
  • Audits

Statistical Analyses

  • Data Management
  • Statistical consultation

eCRF & CRF (Case Report Form)

  • Concept
  • Programming
  • Design (Paper-CRF)

Handling of IMP

  • IMP blinding
  • Logistics, IMP disposal
  • Packaging
  • Labeling
  • Storage (regular and special needs, i.e. cooled)

Pharmacovigilance

  • Systematic inquiry (Literature and Authority Documents)
  • Evaluation and coding of medical terms
  • Legally required cumulative reports (i.e. PSUR / DSUR, RMP)
  • Product consultancy hotline (24/7 if required)
  • Experience in with Medical Device Vigilance

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

We are looking forward to your request.

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