Creation of all documents
- Trial Master File (TMF)
- Investigator Site File (ISF)
- Case Report Form (CRF)
- Investigator Brochure (IB)
- Study Protocol
- Clinical study report
- Patient consent form
- Data protection declaration
- Ethic aprovelm
- Training material
Selection of centers
Clinical monitoring
Data Management
Preparation/writing of publications for international and German journals
Preparation of presentations/abstracts/poster
Literature search
Examining your data
Creation of graphs, figures and tables
Statistics
Preparation/writing of publications for international and German journals
Preparation of presentations/abstracts/poster
Re-editing of the publication in the submission process
Valid ICH-GCP certificate
Site Selection Visit
Pre-study-qualification visit
Site Initiation Visit
Site Monitoring Visit
Close Out Visit
Clinical Monitoring
Data Management
Organisation of Investigator Meetings/Trainings
Preparation and provision of regulatory documents
Query resolution
Preparation for audits and inspections
Establishment and optimization of assays/methods
Establishment of existing methods to other instruments
Adaptation of assay to other experimental conditions/species
ELISA
Western-Blot
Kinetic measurement
Activity measurements
Photometric/Luminescenc based measurements
Fluorescence measurement
HPLC/FPLC
Protein purification
Protein phosphorylation
Centrifugations
Radioactive measurements
Project preparation/proposal
Grant proposals
Case report forms (CRF)
Ethics proposal
Selection of participating centers
Motivation of data collection
Clinical monitoring of the data provided
Statistics
Preparation/writing of publications for international and German journals
Preparation of presentations, abstracts and posters
Statistics
Power analyses and sample size calculation
Interim analysis/snapshot of data
Creation of graphs, figures and tables
Creation of the case report forms (CRF) and Training
Clinical monitoring of the data provided
Preparation/writing of publications for international and German journals
Preparation of presentations/abstracts/poster
Literature search on medical, biotechnology and biochemistry subjects
Summary and compilation of the publications found
Scientific background of product flyer
Delivery of pictures, photos, charts due to copy right agreements
Design of product flyers
Creation of press releases