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Clinical Trials Facility

This well-equipped clinical trials facility provides comprehensive capabilities for oncology and hematology research.

FACILITY

ONCO-HEMATOLOGY WARD
Location

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.

PHARMACY
Location

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.

AMBULATORY
Location

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

The hospital equipment was selected in a way dedicated to clinical trials. All equipment has valid validation, certificates and technical passports.

Hematology and oncology department:

- infusion pumps- heart monitors- satellite clocks- centrifuges with cooling- deep freeze freezers- resuscitation kit

Study drug:

- pharmaceutical refrigerators 2-8 degrees- pharmaceutical freezers - 20 degrees- pharmaceutical freezers - 80 degrees- remote temperature control system with alarm system- chamber for the preparation of cytostatics

Outpatient section / vital signs:

- stadiometers- scales- ECG machines- centrifuges with cooling- laboratory incubators- ultrasound machine

PERSONNEL

The staff of the center are

- 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.

GCP training

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

SOURCE DATA / MEDICAL RECORDS

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.

SITE ORGANIZATION

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.

QUALITY CONTROL (PROCEDURES)

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

(THERAPEUTIC AREAS)

PORTFOLIO

INIDCATIONS

HEMATOLOGY

NHL-B, NHL-T, CLL, MDS, AML, MPN (MF, PV, ET, CML), ITP, MM, RARE DISEASE

Michal Kwiatek
MD, PhD

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Lukasz Pruchniewski
MD, PhD

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Maciej Kazmierczak
MD, PhD

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Show data
INDICATIONPHASERECRUITMENT PERIODRANDOMIZATION
AML22017-201926
ITP.22017-201816
ITP.32021-202110
MF after JAK-I32021 - aktualnie6
CLL32019-202049
CLL32022-202214
1 L CLL / RR CLL22022 - 202318
R/R DLBCL32021 - aktualnie14
INDOLENT NHL-B12021-20229
NHL-B12021-20225
NHL-B12021-202217
1 L CLL / RR CLL32022 - aktualnie12
ITP.22022-20229
R/R FL32022 - aktualnie6
R/R FL22020-20219
R/R NHL-B12023 - aktualnie4
PNH32021-20212
PNH32021-20212
1 L DLBCL22023 - 20234
R/R NHL-B12022-20229
R/R MCL32022 - aktualnie4
INIDCATIONS

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

Piotr Tomczak
MD, PhD

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Renata Szoszkiewicz,
MD, PhD

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Show data
INDICATIONPHASERECRUITMENT PERIODRANDOMIZATION
mCRC - 1st line12021-20224
Kidney Cancer, Melanoma12020-202132
Melanoma32022-current2
TNBC22018-20199
BC - HR+/HER2-32021-20224
UROTHELIAL CANCER22020-202212
UROTHELIAL CANCER - neoadjuvant trament + radical cystectomy32023-current4
SOLID TUMORS (basket)12022-20235
mCRC with PI3K mut12020-20223
Prostate Cancer12021-20226
TNBC32022-20225
INIDCATIONS

WOMEN’S HEALTH

FIBROIDS, ENDOMETRIOSIS, HOT FLASHES, OSTEOPOROSIS

Krzysztof Szymanowski
MD, PhD

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Anna Dera - Szymanowska
MD, PhD

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Show data
INDICATIONPHASERECRUITMENT PERIODRANDOMIZATION
Fibroids32018-201910
Endometriosis32019-202032
Endometriosis22021-202217
Osteoporosis32020-202056
Osteoporosis32022-202226
Hot Flashes32020-2021104
Hot Flashes32021-202112
Hot Flashes22021-202124
Hot flashes due to endocrine adjuvant breast cancer treatment32022-aktualnie9
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Księdza Stanisława Kozierowskiego 24 60-185 Skórzewo (Poznan), Poland

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