Project Management
- Access to medical and scientific expertise in all areas of laboratory medicine
- Individualized solutions for laboratory analytics
- Highly experienced, scientific project managers as competent contact persons for all project phases
- Support in reporting and publishing data
- Multilingual service (German, English, Polish)
Sample Management
- Building of study-specific and visit-specific laboratory kits for standardized sampling at each clinical site
- User-friendly laboratory manual for clinical sites with detailed instructions for specimen collection, processing and shipment
- Laminated short instructions
- Supply of clinical sites with laboratory equipment such as pipettes and sample containers
- Organization of specimen shipment by company's own courier drivers or cost-efficient, international courier service providers including sample tracking
- Support in the creation of pro forma invoices and customs documents
Laboratory Analyses
- 3000+ analyses from all areas of laboratory diagnostics such as immunology, genetics, pharmacogenetics, pharmacology, pathogen diagnostics, histopathology etc.
- Comprehensive portfolio of established biomarkers
- Extensive range of methods from automated high-throughput analysis to highly standardized manual laboratory analysis
- Implementation of new analyses according to study protocol requirements
- Sample processing such as DNA/RNA isolation and cell purification (PBMC) using study-specific protocols
- Determination of sample stability under defined conditions (sample type, need for stabilizers, storage temperature and duration)
Sample Archiving
- 24/7 temperature controlled sample storage at 2-8°C, -20°C, -80°C or in liquid nitrogen
- Archiving of retention samples
- Storage of remaining stocks from safety parameters
- Sample registration in archiving software guarantees individual traceability of archived samples and fast sample provision
- Organization of specimen shipment to the customer or third parties
Data Management
- Controlled processes of data collection, documentation and data transmission
- Collection of laboratory data in a global, web-based database (LabOne)
- Compliant to FDA 21 CFR Part 11
- 24/7 access to study data in real-time
- Color-coded laboratory results
- Customer-specific reports
- Trend analyses and monitoring of trial progress
- Electronic data transfer in the desired data format