Clinical Studies in the Atherothrombosis Research Centre of the University of Ioannina

In addition to the basic and translational research activities, the Atherothrombosis Research Centre (ARC) of the University of Ioannina (UOI), provides services for Clinical Studies which include all phases (I-IV) Clinical Trials as well as Bioequivalence Studies.
Services might be, but not limited to, providing expertise, scientific support and consultation to study designs (ex. medical writing, statistical input, sample size estimations, etc.), equipment, laboratory facilities and infrastructures to act as study site for the conduct of Clinical Trials and Bioequivalence Studies.
The laboratory facilities for the Bioequivalence studies exist in the Biomedical and Bionalytical Centre (BAC) http://bac.chem.uoi.gr/index.php/el/home_gr/, which is associated with ARC.
ARC has a specific organizational structure and follows Standard Operating Procedures (SOPs) so as to ensure high quality standards in its operation.
ARC may act as a single site or as a coordinating site (in multicenter studies), for the conduct of a clinical study upon Sponsor’s assignment.
Sponsors can be local or multinational Pharma companies and/or Contract Research Organizations (CROs), Academic Communities, Scientific Societies or Physicians who independently conduct clinical studies in Academic, Public or Private Institutions (Investigator Initiated Studies; IIS / Investigator Sponsored Studies; ISS).
Roles of project teams per study are as defined in the ICH-GCP E6 (R2).

1. Academic board of the ARC
The Academic board of ARC / Board of Directors (BoD), is consisted of 6 Executive Members who are Professors in the UOI. BoD is the cooperating group that leads all the activities of ARC including the conduct of Clinical Trials and Bioequivalence Studies and has the overall supervision of all projects. BoD is the main line of communication between Sponsors and project teams.

Executive Members
• Tselepis Alexandros, Professor of Biochemistry-Clinical Chemistry, President and Chief Executive Officer (CEO) of the BoD.
• Elisaf Moses, Professor of Internal Medicine, Vice-President
• Katapodis Petros, Assistant Professor of Biology, Member
• Milionis Haralampos, Professor of Internal Medicine
• Stamatis Haralambos, Professor of Biotechnology, Member
• Tsoukatos Demokritos, Professor of Biochemistry, Member
• Tzakos Andreas, Associate Professor of Organic Chemistry, Member

Minimum number of BoD that must be present to constitute a valid meeting (Quorum) is the 50% of total Executive Members eligible to attend.

Advisors of the BoD
The following Professors, Experts in Clinical Trials and Bioequivalence Studies, may also be in attendance during the BoD meetings, upon invitation from the President, in order to contribute with their expertise to discussions.

• Gerothanasis Ioannis, Professor of Organic Chemistry
• Goudevenos John, Emeritus Professor of Cardiology
• Hatzimichael Eleftheria, Assistant Professor of Hematology
• Korantzopoulos Panagiotis, Assistant Professor of Cardiology
• Liberopoulos Evangelos, Associate Professor of Internal Medicine
• Panagiotakos Demosthenes, Professor of Epidemiology
• Pentheroudakis Georgios, Associate Professor of Oncology
• Siminelakis Stavros, Associate Professor of Cardiac Surgery
• Tsilidis Konstantinos, Assistant Professor of Epidemiology
• Tsimihodimos Vasileios, Assistant Professor of Internal Medicine
• Tzimas Petros, Assistant Professor of Anesthesiology

2. Steering Committee
Steering Committee intends to provide guidance, scientific advice and relevant required background in the conduct of Cinical Trials and Bioequivalence Studies. Steering Committee is also responsible for the review of all submitted documentation of a project in order to gain favorable opinion from relevant Authorities as applicable (Regulatory Authorities including National Organization for Medicines – EOF, Central/Local Ethics Committees, and Financial Management Bodies called ELKE/ELKEA). Detailed activities of Steering Committee are defined and described in a written agreement per project, with all applicable terms and conditions for the support that Steering Committee provides to each project.
The Steering Committee is a dynamic group of experts and its composition is defined according to each project’s needs and requirements. Members are either from academic community or/and they might be physicians with significant previous experience in Clinical Trials. They are originated from Greece (local level) or abroad (located in USA, Europe).
Administrative duties of the committee are handled by a coordinator -project coordinator- who is responsible to ensure that projects’ tasks and responsibilities are met and fulfilled according to the SOPs and executed Service Agreements. Coordinator is appointed by the CEO of the BoD. Steering Committee’s meetings can be face-to face or/and through skype and teleconferences. Minimum number of members that must be present to constitute a valid meeting (Quorum) is the 1/3 of total members eligible to attend.

Potential Members (based on each project)
• Aivaliotis Michalis, Associate Professor of Medicine (Greece)
• Alexopoulos Dimitrios, Professor of Cardiology (Greece)
• Badimon Lina, Professor of Biochemistry-Molecular Biology (Spain)
• Cattaneo Marco, Professor of Haematology (Italy)
• Chapman John, Professor of Biochemistry and Molecular Biology (France)
• Davlouros Periklis, Professor of Cardiology (Greece)
• Douketis James, Professor of Internal Medicine (Canada)
• Falanga Anna, Professor of Haematology (Italy)
• Garbis Spyros, Associate Professor, Institute for Life Sciences (UK)
• Gerotziafas Grigorios, Professor of Haematology (France)
• Giannakoulas George, Assistant Professor of Cardiology (Greece)
• Gurbel Paul, Professor of Cardiology (USA)
• Hahalis Georgios, Professor of Cardiology (Greece)
• Iliodromitis Efstathios, Professor of Cardiology (Greece)
• Kayikiouglou Meral, Professor of Cardiology (Turkey)
• Konstantinides Stavros, Professor of Cardiology (Germany)
• Kypraios Kyriakos, Professor of Pharmacology (Greece)
• Matsagkas Miltiadis, Professor of Vascular Surgery (Greece)
• Mikhaelidis Dimitri, Emeritus Professor of Cardiology (UK)
• Nikas Dimitrios, MD, PhD Cardiologist, University Hospital of Ioannina (Greece)
• Ntaios Georgios, Professor of Internal Medicine (Greece)
• Parthenakis Fragiskos Professor of Cardiology (Greece)
• Pipilis Athanassios, Cardiologist, Director of the Cardiology Department of Hygeia Hospital (Greece)
• Ralidis Loukianos Associate Professor of Cardiology (Greece)
• Richter Dimitrios, Cardiologist, Director of the Cardiology Department of Euroclinic (Greece)
• Sivolapenko Grigoris, Associate Professor of Pharmacokinetics (Greece)
• Spyropoulos Alex, Professor of Internal Medicine (USA)
• Stellos Konstantinos, Professor of Cardiology (UK)
• Tentolouris Nikolaos, Professor of Internal Medicine (Greece)
• Tokgozoglu Lale, Professor of Cardiology (Turkey)
• Tsimikas Sotirios, Professor of Medicine, Director of Vascular Medicine (USA)
• Vasilikos Vasileios, Professor of Cardiology (Greece)
• Voudris Vasileios, Cardiologist, Director of the Cardiology Department, Onaseio Hospital (Greece)

3. Clinical Research Project Team
The following personnel may participate and contribute to various activities such as start-up activities, preparation of required documentation, clinical operation activities etc., during the design and conduct of a Clinical Trial, or a Bioequivalence Study. Clinical Research Project Team is a dynamic open group and other individuals from CROs, Pharma industry may join the team offering their expertise.

Permanent Laboratory Teaching Staff
• Mousis Vassileios, PhD, Chemist
• Pantazi Despoina, PhD, Biochemist
• Tellis Konstantinos, PhD, Biochemist

Non Permanent Collaborators
• Chatziathanasiadou Maria, MSc, Biologist
• Kalantzi Kallirroi, MD, PhD, Cardiologist
• Ntalas Ioannis, MD, PhD, Cardiologist
• Papadaki Stelina, MSc, Biologist
• Stylos Evgenios, MSc, Biologist
• Tsouka Aikaterini, MSc, Biochemist

                                                      ARC Organogram