Our Early Clinical-Trial Unit (ECTU) is a new core-facility at the University Hospital Halle to provide excellent service in conception, conduction and analysis of phase I and phase II trials as well as maximum safety for participating patients.
Being the largest hospital in Saxony-Anhalt, the University Hospital Halle treats more than 230.000 patients a year. The ECTU is embedded in the certified Krukenberg-Cancer-Centre, including a network of specialized institutions with experience in cancer treatment and research, which are involved in numerous clinical trials.
We have access to:
- An acredited (DIN EN ISO 9001:2015) central laboratory offering comprehensive servie 24 hours 7 days
- An acreditated pathology department experienced in tumor histology and clinicla trials participation
- An acredited (DIN EN ISO/IEC 17025) molecular pathology for mutation and fusion analysis.
- A team of GCP trained clinical investigators, study nurses as well as administrative staff experienced in the conduction of clinical trials.
- A JACIE-certified GMP laboratory licensed for the manufacturing, distribution and storage of cellular therapeutics (including investigational products) according to German Drug Law (AMG).
- A GMP pharmacy licensed according to german drug law (AMG) for production, packaging, blinding, randomization, export, and distribution of investigational products
- A digital central database-system of all patients treated for malignant diseases.
- A certified tumor tissue bank
The ECTU is an independant department linked to the hematology-oncology department but open to all medical departments as well as cooperating partners. It offers three rooms for in-patient treatment equiped with five therapy chairs and two to three bed places, all equiped with up-to-date monitoring systems, WLAN- and cable TV service. Access to the ECTU is electronically controlled and restricted to authorized personnel only. We provide a team of GCP-trained, trial-experienced physicians and specialized study nurses which guarantee study conduct in accordance with national and international law as well as sponsor preferences. Synchronized clocks are installed in all rooms ensuring accurate timing of dosing and pharmacokinetic sampling. Special rooms are dedicated for the safe storage of investigational products and biological specimen (at room temperature as well as at 4°C, -20°C and -80°C). All fridges and freezers are connected to a central surveillance system.