CRS-Group > locations of CRS > Grünstadt > Infrastructure
CTSM
The facilities in Grünstadt provide a medication storage room of 35 m2 including one refrigerator (2 – 8 °C), temperature and humidity controlled via automatic device, alarm system connected. After business hours the alarm system alerts co-workers via mobile phone.
One separate room for primary and secondary packaging and labelling
This GMP area has received a restricted manufacturing license for packaging and labelling by the local authorities in 1998. The last GMP inspection by the authority took place in 2006.
Archives
CRS-Mannheim and CRS-Grünstadt study archives and Bioanalytical archive are located in the basement of the extension building in Grünstadt, comprising an approximate area of 90 m².
The archiving period of study related data is based on legal requirements (AMG) and the Note for Guidance on Good Clinical Practice, i.e. for at least 15 years after completion or discontinuation of the trial.
The archive rooms are secured with fire resistant walls and T30 fire doors as well as smoke detectors inside which are connected to the central alarm system and the mobile of our designated data security administrator.
In addition to storing trial documents in paper form, all data are filed on CD-Roms and kept locked in a steel cabinet in a different building.
Access to the archives is strictly limited to appointed staff. Archiving and removal of files is controlled via signature of the respective person.
All study files are listed electronically to ensure quick and easy finding of required data.
Bioanalytics
All CRS bioanalytical staff is specialized and well trained in chromatographic bioanalysis and ELISA-procedures
- 1 Chemist (PhD)
- 1 Chemist (MSc)
- 1 Chemical Engineer (BSc)
- 2 Senior Laboratory Operators
- 7 Senior Analysts
Clinical Data Managment, IT
- Personal computer: 26 (Intel Pentium IV >2,5 GHz)
- Network: Windows Server 2003
- Standard software: Windows XP pro, Office 2003, Adobe Acrobat
- Data Management System: Oracle Clinical (Version 4.0) Sample size est.
- nQuery Advisor
- Randomisation: RancodeCoding: MedDRA subscription, WHOEvaluation: SAS 9.1 and older versions, Testimate, WinNonlin
- CRF preparation: MS Word