In the Department’s range of activities are:
- analysis/validation of clinical research protocols,
- preparation of documentation necessary to obtain consents to conduct the study (Bioethics Commission, URPL, EV),
- conducting audits and verification of potential partners and research units,
- monitoring of non-commercial research in units,
- maintenance of documentation: creating (TMF), SOP, test-specific instructions,
- negotiating contracts with units, also in cooperation with the Clinical Research Implementation Unit,
- pharmacovigilance: keeping a register of adverse reactions and reporting them to Bioethics Commission and EUDRAVIGILANCE base, as well as preparing annual reports regarding patients’ safety,
- quality management in research units (compliance with legal acts, procedures of the MUG, and GCP).
Team of the Department of Academic CRO consists of:
- Damian Świeczkowski, Ph.D., MBA
- Magdalena Jaskólska, M. Pharm.
- Anna Koelmer, M.A.
- Patrycja Kondej-Welzman, M.A.
- Anna Pirska-Żochowska, M. Eng.
- Joanna Porzezińska, M.A.
- Aleksandra Szłapka, M.A.
- Adam Wyszomirski, M. Eng.
- Kamila Zając, M. Pharm.
Contact
Damian Świeczkowski, Ph. D., MBA
E-mail: damian.swieczkowski@gumed.edu.pl
Telefon kontaktowy: 58 349 27 74