Consulting, Planning and Coordination

  • Conception and creation of GCP compliant clinical trial protocols
  • Budget, process and resource planning
  • Registration in public clinical trial registries

Fund Raising (Third Party)

  • Support of application procedures for public funding (e.g. German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG)) as well as for funding by foundations
  • Acquisition of industry funded clinical trials – Sponsor Initiated Trials (SITs)
  • Negotiation with pharmaceutical and medical device industry partners

GCP compliant Clinical Trial Coordination

  • Coordination and project management
  • Monitoring in Germany and Europe
  • Conducting clinical trials in collaboration with our clinical partners, e.g. trained and experienced investigators and study nurses
  • Medical manufacturing and shipping conducted by our collaboration partner UMC Pharmacy

Regulatory Affairs & Quality Management

  • Fulfillment of all sponsor obligations on behalf of UMC
  • Preparation and submission of applications with federal authorities, regional authorities and ethics committees
  • Creation and maintenance of Trial Master Files (TMF) / Investigator Site Files (ISF)
  • Professional preparation of audits and inspections
  • Coordination of audits and reviews of trial documents

Safety Management

  • Management of Serious Adverse Events (SAEs)
  • SUSAR reporting to public authorities, ethics committees and investigators
  • Accreditation to electronical reporting of Suspected Serious Adverse Events (SUSARS) to national and international public authorities
  • Development of Safety Update Reports (DSUR) according to §13(6)GCP-V


  • Biometrical part of the clinical trial protocol including sample size planning
  • Statistical analysis planning
  • Biometrical evaluation
  • (Web-based) randomisation
  • Utilisation of complex biometrical methods

Data Management

  • Creation of paper-based or electronic case report forms (CRF)
  • Creation of a clinical trial data base
  • Data entry and coding
  • Data validation and query management
  • SAE reconciliation

Study Systems and Processes / Information Technology

  • Web-based randomisation
  • Homepages for clinical trials with integrated clinical trial tools
  • Software development

Closing Activities

  • Preparation of final clinical trial report
  • Preparation of §42b AMG report synopsis
  • Publication of results
  • Filing

Professional Training Programmes for Research Staff

  • Certified trainings and seminars, e.g. for investigators, scientists, study nurses, monitors and medical students
  • in-house trainings upon request

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