Medical University of Lodz is one of ten beneficiaries of the call for the creation and development of Clinical Research Support Centres which was announced by Medical Research Agency. MUL’s project entitled ‘Clinical Research Support Centre of the Medical University of Lodz (CRSC/CWBK): comprehensive and systemic support for the implementation of clinical trials in the shared services model’ has been most highly rated and received the funding in the amount of over PLN 11 million.

Medical Research Agency allocated a total of PLN 100 million for a network of ten specialised Clinical Research Support Centres. Newly-established centres will enable a better organisation of the clinical trials in Poland. The initiative is aimed at making the clinical trials market more attractive thereby increasing the patients’ chances of accessing modern and innovative therapies, the frequency of selection of our national research centres by sponsors as well as the number of conducted research schemes.

The obtained funding will allow the University Clinical Trial Unit to provide a systemic support for clinical trials implemented by the University and the academic hospitals.  The research network will be complemented with the cooperation with primary health care units, provincial hospitals and other clinical partners. The project schedule includes the preparation and commissioning of the centralised infrastructure, the implementation of systemic solutions and staff development according to the model standards of Medical Research Agency.

The maximisation of the benefits obtained from the project will be possible thanks to the coordination and application of shared services model at the three following levels:

1) conducting research as a sponsor or as a research unit at the sponsor’s request i.e. requested by Academic Research Organisation (ARO) (shared services for the research and development teams, coordination of support processes i.e. obtaining all the relevant approvals and permits, logistics of

tested medicinal products, quality assurance and control, planning, biostatistics, pharmacovigilance);

2) conducting research as a representative of the centres of Site Management Organisation (SMO) network (active sourcing of clinical trial, point of contact for business partners, quality assurance and coordination, scientific advice, payment management, standardisation of hospital services);

3) conducting research as an early-stage research centre: ensuring adequate quality and safety of early-stage research.

Clinical Research Support Centre will be located in the vicinity of the Central Clinical Hospital, which will facilitate the use of hospital resources i.e. the pharmacy, the diagnostic equipment, the laboratory and the intensive care unit. ‘On the other hand, the centralised infrastructure of CRSC/CWBK will be available to all the clinical hospitals but the trials that will require the patient hospitalisation will be carried out within highly-specialised hospital departments’, says Ireneusz Staroń, Director of MUL Clinical Trial Unit.

CWBK will operate within the model of shared services for clinical hospitals in the field of clinical trial sourcing, initial feasibility study, current contact with clinical trial sponsors and coordination of the research process. The project implementation will also involve the establishment of the Early-stage Clinical Trial Centre which will focus on the deployment of early-stage clinical projects covering the majority of medical areas. Ultimately, once the second stage of Clinical and Didactic Centre construction has been completed and the Academic Oncology Centre established, the Centre will place particular emphasis on oncology.