Facilities

Charité Research Organisation operates a Phase I unit located in the main Charité hospital tower in central Berlin. This research unit provides 40 beds, direct access to emergency and intensive care facilities, wide range of diagnostic equipment and supports seamless collaboration with the surrounding clinics.

The unit layout is flexible and can be adapted to the ever changing needs of healthy volunteer and patient studies undertaken across a wide range of therapeutic areas.

While an ability to collaborate seamlessly with Charité clinics to access diagnostics technologies is a key attribute of the CRO set-up, the research unit itself is home to a wide range of equipment. ECG equipment and a MUSE network from GE Healthcare are in place. This includes a full, unit wide, telemetry system. The unit is home to a sophisticated sample preparation laboratory that is additionally able to run some safety assays locally. The unit’s drug storage facility offers temperature controlled storage for ambient, refrigerated and frozen supplies.

Subject safety is the top priority of any clinical study and CRO. Charité Research Organisation employs a range of technologies and laboratory capabilities to help minimize risk and facilitate early detection of any problems. At a very basic level this includes the latest bedside monitoring equipment and unit wide telemetry systems. The ethos of “being there at the bedside” during infusions in FTIH studies is a key approach, with subjects monitored directly by physicians during and post infusion. The research unit’s on-site sample processing laboratory also provides access to a bedside cytokine analysis system that can give readouts on cytokine activity within 20 minutes. This is commonly used to look for the earliest possible warning signs in FTIH biologics studies, allowing speedy action to be taken, should it ever be necessary.

The Charité Research Organisation unit is home to a fully equipped respiratory function laboratory. This is extensively utilized in COPD and asthma protocols and it is also used for pulmonary function safety assessments in other selected studies.

Equipment includes:

• MasterScope TP spirometry equipment
• MasterScreen-Body for body plethysmography
• MasterScreen CPX ergospirometry system with VIAsprint 150p bike system
• APS Aerosol Provocation System
• Niox

The research unit is equipped with a sophisticated sample processing laboratory staffed by highly experienced and qualified personnel. This allows complex sample preparation steps to be undertaken, including the incubation and stabilization of whole blood samples for subsequent biomarker analysis.

Facilities include:

• Ambient, refrigerated, -20°C, -80°C storage
• All storage is backed up by hospital emergency power supply
• Duplicate storage facilities available in event of emergency
• 24h validated temperature control, logging and alarm system
• Refrigerated centrifuges
• Laminar flow
• Incubator
• Bedside cytokine assay
• Access to dry ice supplies for shipping
• Experienced in collaborating with a wide range of central laboratories
• Ability to collaborate for specialist sample handing, such as shock-freezing of tissue biopsies

Charité Research Organisation collaborates extensively with Hubertus Apotheke am Salzufer to facilitate complex IMP handling and preparation. Hubertus possesses a GMP license and has been subject to multiple sponsor audits, making it an ideal partner for packaging and handling of trial supplies from bulk. Where preparation of IMP on site by unblinded staff is required, Hubertus is able to provide pharmacists to attend the unit 24h a day.