CRS-Group > locations of CRS > Mönchengladbach > Infrastructure
Short Summary
- Rear front of the building
- Intermediate care station
Qualified staff based on 50 employees in full and part time job positions:
- 30 clinical
- 20 non-clinical
Ambulatory capacities:
- Standard facilities for up to 60 volunteers optional extension area (312 m2)
Overnight facilities (in total 62 beds):
- 10 beds intermediate-care station for observation
- 24 beds hospital standard - capabilities for dosing, monitoring at the bedside (4-bed rooms)
- 28 beds hotel standard - optimised for the confinement of elderly volunteers (2-4 bed rooms)
- Experience with long-term confinement of up to 46 days in total
Centralised archive:
- Capacities are designed for the future
- Controlled environmental conditions and access
Pharmacy:
- GMP area audited by the local authorities clean room condition A to C product & manufacturing license for packaging and labelling
The Unit
- Bathroom
- Room - hospital standard
The Clinical Pharmacology Unit of CRS-Mönchengladbach offers a daily capacity of 60 volunteers for clinical confinement or ambulatory visits. Ten of these beds are located in our intensive care unit and are fully equipped for continuous safety monitoring, as required for specific trials, such as first in man, i.v. drug administration or cardiac monitoring trials.
CRS-MG employs approximately 50 clinical staff, including full time and part time employees. The full time crew is composed among others of physicians, nurses and laboratory technicians, each one being more specifically responsible for a defined clinical trial and co-ordinating the clinical activity.
The planning and organisation of the different trial teams is administered and supervised by the Head of Clinical Services. Also belonging to the Clinical Pharmacology Unit, non clinical staff such as a pharmacist as Qualified Person and a trained cook are actively involved in each trial.
Volunteers Area
The dining halls and overnight facilities of CRS-Mönchengladbach are of hotel style to guarantee the maximum comfort for the participants during long-term confinement.
During the day, the volunteers may choose between a variety of activities such as TV, games, conversation and internet surfing. To enable a convivial atmosphere, several separate leisure rooms are at the disposal of the volunteers. All in all, the volunteers’ confinement and leisure section covers an indoor area of 500 m².
Additionally, a 120 m² outdoor terrace improves the volunteer’s conditions. This outdoor terrace is directly controlled from the nurses’ -office and the catering area. Entry to the catering area is restricted to authorised personnel only. Standardised meals are freshly prepared by our own chef. Food specialities and calorific calculations are made following an appropriate plan designed by our nutritionist. The chef, aware of the importance and consequences of food in clinical trials, is informed and involved in the dietary program and planning of each clinical trial, in particular with regards to PK days and food interaction studies.
Certified GMP Area
Medication for clinical trials is stored and handled in a separate, security-controlled area: the GMP area. The GMP area consists of three rooms: one for drug storage and labelling, one lock for personnel and material, and one clean room for preparation. The area has received a restricted manufacturing license by the local authorities in 2004.
Access to the GMP area is limited to authorised and specifically trained personnel only. Investigational products are checked upon receipt and preserved in the storage room under the supervision of a qualified person (QP) and the distribution manager. Drugs are kept in locked steel cabinets or refrigerator which are allocated to drugs according to their authorisation status: "in quarantine", "free for use", "not free for use".
The storage is temperature and humidity controlled via automatic device which is connected to an alarm system and controlled every working day. All investigational products being brought in and taken out of the GMP area are thoroughly documented. With this, the appropriate handling of medication according to the sponsor’s instructions can be ensured.
If requested, specific trial medication can be prepared by the QP or her deputy. All drug preparation steps, except labelling, take place in the clean room. All preparation procedures are performed according to our "4-eye standard", i.e. one person prepares the medication as requested by the trial protocol, while a qualified person controls the preparation and documentation process. Drugs administered intravenously are prepared under the laminar hood, in general by one of our physicians.
This preparation room is kept sterile through a pressure cascade system binding the three rooms of the GMP area. The particulates in the air are measured and controlled on a regular basis enabling a prompt replacement of filters in the air conditioning system when necessary, and a permanently clean environment. The barometric pressure is monitored by our distribution manager every working day and the control of the environmental conditions in the GMP area is documented accordingly. Before entering the clean room, the authorised persons are to follow a standardised disinfection procedure, which takes place in the intermediate room: the lock. Investigational products and material might be handed over to the QP without stepping in the clean room, thanks to an air lock, as recommended by local and GMP requirements.
Laboratory for sample processing
The handling and storage of samples at CRS-Mönchengladbach is performed in accordance with Good Laboratory Practice (GLP) requirements. Standard haematology, biochemistry and urinalysis are performed according to GLP standards by an associated laboratory. Electronic data transmission guarantees the availability of results of the safety parameters within 12 hours. Drug screening for amphetamines/methamphetamines, cannabinoids, cocaine, opiates, barbiturates, benzodiazepines as well as AIDS testing (HIV I/II) and hepatitis B and C screens are routinely performed. In addition, target parameters such as serum and/or urine concentrations of hormones may be determined on request.
Clinical Assessments
In addition to the current Phase I equipment (standard laboratory equipment, BP and PR measurement devices, digital 12 lead ECG, Holter ECG, exercise tolerance test devices), CRS-MG offers intensive monitoring via a telemetry system permitting a 72-hours full data disclosure of ECG, respiratory rate, heart rate and blood pressure measurements recording. Aware of the always growing needs of research in terms of safety and technology, CRS-Mönchengladbach regularly invests in new, efficient and demanded material, such as for instance a SphygmoCor® Pulse Wave Velocity Vx system.
Centrally controlled Archive
CRS-MG has its archive on-site, directly in the first floor of the building, which allows the storage of trial documents (e.g. CRFs, ITF, source data, etc.) for up to 15 years as requested by the national regulatory requirement (AMG), as well as an immediate access if needed. All archived documents are listed electronically, to ensure a prompt finding. Additionally, the dates of storage and removal are documented as a final up-date.
The access to the archive is restricted to a limited number of persons, controlled and documented through an electronic card system. A fire resistant wall isolation protects the area in case of fire outside of the archive. Additionally, in case of an incident starting inside of the archive, the area is supervised by a fire detector, which is linked to a general alarm system.