Phase Unit I.
Since 2012, the Phase I Unit supports development, implementation and conduct of Phase I (including first-in human) and IIa clinical trials in order to assess and ensure safety, pharmacokinetics, and/or pharmacodynamics of therapeutic products that are subject to ongoing clinical study.
Located within Clinic of Comprehensive Oncology (prolink), its current capacity of 6 semi-monitored in-patient beds and 6 semi-monitored out-patient beds enables enrolling and observing cancer patients, enrolled in Phase I clinical trials. Complex administrative support is provided by Department of Clinical Trials (prolink).
Phase I clinical trials are managed by the most experienced team of dedicated medical oncologists – investigators, study nurses, coordinators and data managers and other health-care professionals (radiologists, pharmacists, laboratory professionals, pathologists etc.). Phase I Unit Advisory Board meets on regular basis to discuss all relevant scientific, medical and operational issues.
The 24/7 unit is equipped by telemetry and Intensive Care Unit (ICU) capacity is available if needed.
As first Czech site, in October 2022 our Phase I Unit obtained GCP certification for first-in human clinical trials, issued by Czech regulatory agency Státní ústav pro kontrolu léčiv in accordance with CTR 536/214 and Czech Law 378/2007 Sb.
Ongoing Phase I clinical trials – prolink na seznam studií
For Phase I capabilities and Feasibility Process, please contact Start-up Specialist on [obfuscate_1_|114|107|112|99|103|100|55|104|110|115|45|90|117].
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