Academic CRO

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The basis of the Academic CRO activity is the preparation of documentation for clinical researches and their conduct.

Range of activities:
  1. Analysis/validation of clinical research protocols;
  2. Preparation of documentation necessary to obtain consents to conduct the study (Bioethics Commission, URPL, EV);
  3. Conducting audits and verification of potential partners and research units; monitoring of non-commercial research in units;
  4. Maintenance of documentation: creating (TMF), SOP, test-specific instructions;
  5. Keeping a register of adverse reactions and reporting them to Bioethics Commission and URPL, EV;
  6. Quality management in research units (compliance with procedurs of the MUG and the UCC regarding to NBK and GCP, Legal acts);
  7. Negotiating contracts with units.
Consultation:
  1. Assistance in creating a clinical research budget;
  2. Organization of a clinical research as a Sponsor.

Key current projects

In 2020, the Department of Non-Commercial Clinical Research Team is implementing three non-commercial clinical trials projects as CRO:

1. Dual Antithrombotic Therapy with Dabigatran and Ticagrelor in Patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI), leader Prof. Miłosz Jaguszewski, M.D., Ph.D.

2. Evaluation of the effectiveness of the use of metoprolol in the prevention of cardiomyopathy and cardiac deaths in patients with Duchenne muscular dystrophy, leader Joanna Kwiatkowska, M.D., Ph.D., D Sc.

3. Phase III clinical research evaluating the efficacy and safety of Avigan (favipiravir) compared to standard care in accordance with the current AOTMiT recommendations in patients with SARS-C0V-2 infection, *leader Tomasz Smiatacz, M.D., Ph.D., D.Sc.

Persons responsible:
  • Magdalena Leszczyńska-Wiloch, Pharm.D. (magdalena.leszczynska-wiloch@gumed.edu.pl, 58 349 10 56)
  • Piotr Kraszewski, M.A. (piotr.kraszewski@gumed.edu.pl, 58 349 10 56).