Clinical Trials Facility
This well-equipped clinical trials facility provides comprehensive capabilities for oncology and hematology research.
FACILITY
The Department of Hematology and Clinical Oncology in our hospital has 12 one-day therapy stations and two single rooms.
The stations are equipped with infusion pumps, cardiomonitors, and an alarm system for patients.
The ward conducts clinical trials with the use of chemotherapy, immunotherapy and targeted therapy.
The hospital pharmacy with a laboratory of cytostatics allows for the preparation of both chemotherapy and immunotherapy for patients.
From the moment of receipt of the drug shipment from the sponsor, the temperature and storage conditions of the drugs are strictly controlled.
Maintained pharmaceutical records provide a solid basis for clinical trial audits and potential inspections by local authorities and the FDA.
The outpatient part of the hospital includes 6 consultation rooms, 4 nursing rooms dedicated to clinical trials, a gynecology office and a treatment room for bone marrow biopsies and targeted tumor biopsies.
As part of the outpatient section, a rest area was also created for patients waiting for blood samples for pharmacokinetics and pharmacodynamics. The outpatient part of the hospital was prepared to carry out 50 visits a day.
DEDICATED EQUIPMENT
Hematology and oncology department:
Study drug:
Outpatient section / vital signs:
PERSONNEL
- administrative staff (contracting, settlement of clinical trials)- patient service office- clinical trial coordinators- qualified nurses- pharmacists- doctors
All employees have current GCP training and undergo periodic training on the most important issues of clinical trials. Our staff is experienced in clinical trials and at the same time a team that is characterized by high empathy for hospital patients.
All employees have current GCP training and undergo periodic training on the most important issues of clinical trials.
Our staff is experienced in clinical trials and at the same time a team that is characterized by high empathy for hospital patients.
QMS
We use hospital electronic medical records, which allow for digital recording of all medical activities, such as patient visits, treatments, drug infusions and stays with patient observation.
The system also fully supports the hospital pharmacy, which allows to track the process of creating and control over prescription drugs and to take care of the delivered IMP.
The system is equipped with the possibility of granting dedicated accesses, and full audit trial, meets all ALCOA standards.
We have an orderly structure of our organization that clearly defines the responsibilities and roles of individual team members.
Our main structural units are: the medical staff of the centre, the coordinating staff, the hospital pharmacy and the administrative staff.
The organization of processes is an important asset in the case of any audits and inspections of clinical trials.
The key processes in the center are carried out in accordance with our SOPs, which allow for daily quality control of the hospital.
The SOPs reflect the real conditions and rules of our work, they can be viewed by sponsor / cro representatives as well as auditors and inspectors.
We have an internal QMS system that documents team training, generating training logs and confirming qualifications
PORTFOLIO
HEMATOLOGY
NHL-B, NHL-T, CLL, MDS, AML, MPN (MF, PV, ET, CML), ITP, MM, RARE DISEASE
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INDICATION | PHASE | RECRUITMENT PERIOD | RANDOMIZATION |
---|---|---|---|
AML | 2 | 2017-2019 | 26 |
ITP. | 2 | 2017-2018 | 16 |
ITP. | 3 | 2021-2021 | 10 |
MF after JAK-I | 3 | 2021 - aktualnie | 6 |
CLL | 3 | 2019-2020 | 49 |
CLL | 3 | 2022-2022 | 14 |
1 L CLL / RR CLL | 2 | 2022 - 2023 | 18 |
R/R DLBCL | 3 | 2021 - aktualnie | 14 |
INDOLENT NHL-B | 1 | 2021-2022 | 9 |
NHL-B | 1 | 2021-2022 | 5 |
NHL-B | 1 | 2021-2022 | 17 |
1 L CLL / RR CLL | 3 | 2022 - aktualnie | 12 |
ITP. | 2 | 2022-2022 | 9 |
R/R FL | 3 | 2022 - aktualnie | 6 |
R/R FL | 2 | 2020-2021 | 9 |
R/R NHL-B | 1 | 2023 - aktualnie | 4 |
PNH | 3 | 2021-2021 | 2 |
PNH | 3 | 2021-2021 | 2 |
1 L DLBCL | 2 | 2023 - 2023 | 4 |
R/R NHL-B | 1 | 2022-2022 | 9 |
R/R MCL | 3 | 2022 - aktualnie | 4 |
ONCOLOGY
SOLID TUMORS:
LUNG CANCER, COLORECTAL CANCER, GASTRIC CANCER, BREAST CANCER (TNBC / HER2+ / HR+), UROTHELIAL CANCER, KIDNEY CANCER, PROSTATE CANCER, MELANOMA, OVARIAN CANCER, ENDOMETRIAL CANCER
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INDICATION | PHASE | RECRUITMENT PERIOD | RANDOMIZATION |
---|---|---|---|
mCRC - 1st line | 1 | 2021-2022 | 4 |
Kidney Cancer, Melanoma | 1 | 2020-2021 | 32 |
Melanoma | 3 | 2022-current | 2 |
TNBC | 2 | 2018-2019 | 9 |
BC - HR+/HER2- | 3 | 2021-2022 | 4 |
UROTHELIAL CANCER | 2 | 2020-2022 | 12 |
UROTHELIAL CANCER - neoadjuvant trament + radical cystectomy | 3 | 2023-current | 4 |
SOLID TUMORS (basket) | 1 | 2022-2023 | 5 |
mCRC with PI3K mut | 1 | 2020-2022 | 3 |
Prostate Cancer | 1 | 2021-2022 | 6 |
TNBC | 3 | 2022-2022 | 5 |
WOMEN’S HEALTH
FIBROIDS, ENDOMETRIOSIS, HOT FLASHES, OSTEOPOROSIS
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INDICATION | PHASE | RECRUITMENT PERIOD | RANDOMIZATION |
---|---|---|---|
Fibroids | 3 | 2018-2019 | 10 |
Endometriosis | 3 | 2019-2020 | 32 |
Endometriosis | 2 | 2021-2022 | 17 |
Osteoporosis | 3 | 2020-2020 | 56 |
Osteoporosis | 3 | 2022-2022 | 26 |
Hot Flashes | 3 | 2020-2021 | 104 |
Hot Flashes | 3 | 2021-2021 | 12 |
Hot Flashes | 2 | 2021-2021 | 24 |
Hot flashes due to endocrine adjuvant breast cancer treatment | 3 | 2022-aktualnie | 9 |
Get the Care You Need
Connect with Our Oncology Team
Phone
Office
Be punctual for meetings and appointments.