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
Biometrics/Biostatistics
- 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
