Early Phase Site
ABOUT THE CENTER
We have a modern Early Phase Research Center that enables the implementation of:
- Early-phase clinical trials in all fields of medicine;
- Monitoring of pharmacokinetics, pharmacodynamics, and drug bioequivalence;
- Projects involving the evaluation of the safety and efficacy of medical devices.
The Center is equipped with, among others:
- Two consultation rooms and a treatment room;
- Four patient rooms with a total of 8 stations, including: 4 outpatient stations, 2 adult inpatient stations, and 2 pediatric inpatient stations with beds meeting intensive care standards;
- A modern, centralized system allowing for continuous monitoring of all vital signs of patients staying in the ward;
- A biological material processing room connected to the in-house hospital laboratory via a pneumatic tube system;
- Medical equipment, including: CARDIOVIT AT-102 G2, Efficia DFM100 Monitor/Defibrillator, Philips Efficia CM12 Patient Monitor (2 units on the ward), infusion pumps for precise intravenous, epidural, parenteral, and enteral infusions (10 units on the ward), ultra-low temperature freezers with temperature recording, monitoring, and alarm notification systems (2 freezers down to -86°C and one down to -30°C);
- Social facilities for patients.
All rooms in the ward are air-conditioned, providing comfort for patients and staff, and ensuring the high-quality operation of the unit.
The center’s infrastructure enables 24/7 continuous patient monitoring (using an atomic clock system, which guarantees the highest time accuracy for performed procedures and the observation of any events involving patients). It also provides necessary safety systems (e.g., call buttons in all patient areas—by the beds, in bathrooms, and in every room of the ward). Patient rooms are prepared for both outpatient visits and hospitalizations, meeting general hospital requirements, and all patient rooms are equipped with separate en-suite bathrooms.
The Early Phase Research Center is located within the Central Clinical Hospital of the Medical University of Łódź, with a direct connection to the Clinical Intensive Care Unit, allowing us to utilize the hospital’s extensive infrastructure.
Clinical Trial Administrative Process
Feasibility/Preparatory Stage
Initial Sponsor Contact with the Research Site
Barlicki University Hospital, Łódź
Pomorska 251, 92-213 Łódź
Contact: Beata Strzelecka
b.strzelecka@csk.umed.pl
phone: 42 675 75 48
University Hospital No. 2
Żeromskiego 113, 90-452 Łódź
Contact: Dorota Prus
d.prus@usk2.lodz.pl; d.prus@skwam.lodz.pl
phone: 42 639 37 77
Uniwersyteckie Centrum Pediatrii im. M. Konopnickiej
ul. Sporna 36/50, 91-738 Łódź
Kontakt: Beata Strzelecka
b.strzelecka@csk.umed.pl
tel.: 42 675 75 48
UMED Clinical Trials Sp. z o.o.
ul. Pomorska 251, budynek A-2, 92-213 Łódź
Kontakt: Anna Krata
a.krata@umed.pl
tel.: 605 786 176
Kontakt ogólny do Działu Badań Komercyjnych w CWBK UMED Łódź:
Dział Badań Komercyjnych CWBK UMED Łódź
E-mail: badania.komercyjne@umed.lodz.pl
Telefon: 42 272 55 52, 605 786 176
Po pozytywnej ocenie wykonalności badania i potwierdzeniu wyboru Ośrodka, Dział Badań Komercyjnych wyznacza osobę do kontaktu ze Sponsorem lub CRO.
Start up stage
Formalizing the Start-Up Payment Agreement
Submission of Required Documentation by the Sponsor/CRO:
1. Contract Proposal and The Attachments
2. Letter of Authorization from Sponsor to CRO to Conduct Negotiations with the Institution
3. Signing Authority for Designated Representatives
4. Proposed Clinical Study Budget: per-patient cost, Investigator/Site split, and procedure catalog (in Polish)
5. List of Equipment to be Supplied for the Study
6. Clinical Trial Protocol and Related Documents, including Polish-language Protocol Synopsis
7. Copy of the Liability Insurance Coverage
8. Confirmation of All Required Approvals: Ethics Committee (KE), Office for Registration of Medicinal Products (URPL), and EudraCT
9. Pharmacy Manual for the Site Pharmacy
10. Lab Manual
For a smooth submission process, please correspond directly with your assigned contact in the CWBK Commercial Trials Unit
Permits and Registrations
- Preparation and submission of documentation to the Ethics Committee and URPL (Office for Registration of Medicinal Products)
- Ensuring trial is listed in required regulatory systems (EudraCT, URPL database).
- Compliance check against legal and ethical requirements
Agreement Negotiations
- Tripartite Agreement Negotiation(Sponsor/Site/Researcher)
- Establishing the financial terms, scope of work, and responsibilities of each party.
- Agreement on data ownership and publication rights for the results
Trial Management and Implementation
- Participant screening and enrolment per the study protocol.
- Management of study logistics: IP handling, shipping, and site pharmacy coordination.
- Ongoing oversight of trial procedures and participant safety monitoring.
- Reporting of adverse events (AE/SAE).
- Providing regulatory and administrative assistance to the Principal Investigator and site staff.
Clinical Trial Completion
- Finalizing patient visits and recruitment
- Archiving of study documentation in accordance the law and previously established requirements.
- Final review of study closure reports and financial close-out
- Source data verification (SDV)