FOR PATIENTSCLINICAL TRIALSMISSIONFOR SPONSORS / CROTEAMCONTACT

A clinical trial is a research program with the participation of patients (study participants), in which the safety of use and effectiveness of a given medicinal substance / medical device are verified. Every new substance or technology is subjected to very detailed and rigorous testing before it is registered and placed on the market. Therefore, patients who participate in a clinical trial are regularly monitored by medical personnel to report their health. Possible deviations from the norm, therefore, are also included in the medical records of the test participant. Based on the analysis of the results obtained during the clinical trial, it can therefore be concluded whether the product meets the safety and efficacy requirements, which gives the basis for the possibility of placing it on the market.

  • care provided by a professional team of specialists,
  • constant monitoring of health in the examined area,
  • access to innovative medicinal substances,
  • contributing to helping other people struggling with the same disease and – thus – to develop medicine.

Information on who can participate in the study is contained in the clinical study protocol. The so-called inclusion and exclusion criteria. Whether a person qualifies for a particular study and thus can participate in it is decided by a doctor who is referred to as a researcher in the nomenclature of clinical trials. He is also required to inform any willing person about the potential benefits and risks of a given study, as well as to answer any patient questions.

The patient’s signing of informed consent to participate in the study obliges him to comply with the guidelines applicable to the particular clinical trial. Depending on the study, the obligations for patients may be different. The participant’s most common tasks include taking the drug as prescribed, undergoing follow-up visits, reporting disturbing symptoms, keeping a control diary of specific parameters, completing questionnaires regarding health status, etc. However, at any time during the clinical trial, the participant may be withdrawn from further participation.

Currently conducted clinical trials:

  • Bilateral Severe Nasal Polypsosis,
  • Meniere’s disease – restarted clinical trial.

Finished clinical trials:

  • Tinnitus,
  • Vertigo,
  • Meniere’s disease,
  • Sudden Sensorineural Hearing Loss,
  • Quality of life research on various medical devices e.g. cochlear implants.

We invite you to cooperate with our team! Contact us:

badania.kliniczne@medincus.pl
mgr Kamila Renke +48 22 46 35 342

Using our experience and the potential of a specialized medical entity, which is the Medincus Hearing and Speech Center, we would like to actively participate in the development of medicine and thus raise the standards of treatment. This is possible thanks to the opportunity to improve the health of patients participating in individual studies and consequently also of the entire population struggling with the disease.

In the field of clinical trials we offer:

  • conducting phase II, III, IV research in the field otolaryngology, audiology, phoniatrics and others areas
  • highly specialised staff – specialists, nurses, pharmacists, technicians and study coordinators who are experienced in conducting this type of clinical trials. They also have GCP certificates and constantly improve their professional qualifications,
  • modern hospital (opened in 2012) together with a department that enables hospitalization of up to 50 patients at the same time,
  • the possibility of expanding the accommodation base for patients up to 100 people,
  • modern, fully equipped examinations rooms and treatments rooms,
  • blood collection point,
  • professional rooms which meet the current requirements for the storage and archiving of medical records and documentation of clinical trials,
  • hospital pharmacy department adapted to store investigational products and meeting the standards for the storage of drugs requiring low temperature and also constant temperature monitoring in terms of maintaining the correct temperatures inside the room, as well as in its individual areas,
  • the opportunity to purchase appropriate equipment and employ specialist staff to conduct clinical trials in allergology and pulmonology area.
Equipment
  • lockable refrigerators with validated temperature monitoring,
  • ENT units,
  • hearing test equipment: audiometric, tympanometric, otoacoustic emission and auditory brainstem response (ABR),
  • equipment for vestibular disorders diagnosis: VEMP, vHit, VNG and ENG,
  • equipment for stroboscopic examination of the vocal organ,
  • laboratory centrifuges,
  • blood pressure monitors, medical scales, pyrometers/thermometers which are used to measure body temperature,
  • ECG with the option of automatic generating a description of the recording,
  • equipment for resuscitation,
  • cardiomonitors, pulse oximeters,
  • infusion pumps,
  • certified refrigerator thermometers (including specialised low-temperature thermometers used to measure the temperature inside the freezer),
  • and full office equipment, fax machines, scanners, printers, etc.

All equipment used at the Trial Site has required equipment passports or/and current manufacturer/service warranty.
We are ready to supplement our medical equipment depending on the clinical trial.

Organisational structure
  • PRINCIPAL INVESTIGATOR
    a physician who is responsible for a trial, has experience in conducting clinical trials according to ICH GCP guidelines, applicable local requirements and legal regulations;
  • TEAM OF CO-RESEARCHERS
    selected individually, it depends on the needs of a trial, consists of doctors with specialties corresponding to the therapeutic field within which the clinical trial is conducted;
  • NURSES
    have IATA and GCP certificates, are experienced in cooperation with laboratories and courier companies transporting biological material;
  • PHARMACISTS
    trained in GCP guidelines;
  • STUDY COORDINATORS
    are specialised in conducting and monitoring clinical trials. They have IATA and GCP certificates, smoothly handle eCRF and electronic drug management systems in the clinical trial – IVRS / IWRS. Study coordinators also collect and maintain source documentation of clinical trial and documentation which is stored at site.
Standards

Patient’s good and safety is the most important thing for us. We want patient’s participation in the clinical trial to be in accordance with the guidelines of Good Clinical Practice. In compliance with these standards we also ensure, that the patient fully understands all aspects related to participation in the clinical trial and that the benefits of treatment under
the implemented project are greater than the possible risk. Our team consists of experienced specialists who watch over the health of subjects participating in clinical trials and can quickly identify possible adverse events.

Within administrative Coordination of clinical trials we can provide:

  • coordination and implementation of projects by experienced investigators who communicate fluently in English,
  • care in keeping records for clinical trials,
  • systematic and reliable entering data in the eCRF system,
  • responding to „query” and explaining any non-conformities that have occurred,
  • supervision over the course of the clinical trial and the schedule of patient visits,
    cooperation with Clinical Research Associates,
  • supervision over the investigational products at our trial site.

During the realisation of the tasks connected with clinical trials we aim to keep the following standards:

  • GUARANTEE OF FEASIBILITY
    when we undertake specific trials/projects we always finish them with success or introduce appropriate modifications after consultation with the Sponsor of clinical trial (if it is necessary),
  • DILIGENCE
    every trial/project is our priority and we do it with care and dedication. We are aware that our work can contribute to the development of the medical industry,
  • TIMELINESS
    we always provide information related to the progress of a trial/project in scheduled time
  • KNOWLEDGE AND EXPERIENCE
    we have the appropriate competences and experience in conducting clinical trials. In
    addition we willingly expand our knowledge through participation in conferences and reading professional literature,
  • ENGAGEMENT
    we treat each trial/project individually and devote enough attention to it. Every day we meticulously fulfill our obligations.

We invite you to cooperate with our team! Contact us:

badania.kliniczne@csim.pl
mgr Kamila Renke +48 22 46 35 342

Prof. Piotr H. Skarżyński, MD, PhD, Msc

Prof. Piotr H. Skarzynski, MD, PhD, MSc finished three specializations: otorhinolaryngology, pediatric otorhinolaryngology and audiology and phoniatrics. He is realizing specialization in public health (since 2020). He is a member of 32 scientific societies. He participated in the 3rd Stakeholders Consultation meeting during which the World Hearing Forum of WHO was announced.

He is also a member of Consultant Committee of International Experts of CPAM-VBMS (for special invitation), a Honorary Member of ORL Danube Society, and a member of the Roster of Experts on Digital Health of WHO. He is also a Vice Chairman of Junior European Rhinology Society (2010–2014), Member of Board (2014–2016), Member of Congress and Meeting Department of European Academy of Otology and Neuro-Otology, Representative Board Member (till 2019) and Vice-President and Institutional Representative (since 2019) of International Society for Telemedicine and e-Health, Regional Representative of Europe of International Society of Audiology and Board Secretary of the Society of Otorhinolaryngologists, Phoniatrists and Audiologists. He is also a Vice-President of Hearring Group, a Member of Hearing Committee of American Academy of Otorhinolaryngology-Head and Neck Surgery and an Auditor of European Federation of Audiology Societies. He is also a Member of the State Examination Committee of Poland in the field of otorhinolaryngology, Expert Witness of Laryngology of Provincial Court of Warsaw (Warszawa-Praga; until 2018), Delegate for Regional Assembly of Regional Medical Chamber in Warsaw, a member of Young Scientists Council of Medical University of Warsaw and a Member of Scientific Council of the Institute of Physiology and Pathology of Hearing. Moreover, he is a member of Policy Council of Audiophonology at the Medical University of Warsaw, a candidate for an expert of Smart Growth Operational Programme 2014-2020 (The National Centre for Research and Development), a member of the University Council of the Maria Grzegorzewska University, a member of the Policy Council of „Health of Poles” Congress and a member of the Team of Experts to develop and update the program of specialization in the field of pediatric otorhinolaryngology at the Medical Center of Postgraduate Education. He is an active participant of many conferences – over 1869 presentations (117 as an Invited Speaker, 128 round tables, 140 courses as an Instructor), 957 publications (IF – 226,681, IC – 48781,04, scientific points of Ministry of Science and Higher Education – 11822). His papers are cited by national and international researchers (1207 according to Scopus, 2262 acc. to Google Scholar, h-index 15 acc. to Scopus and Web of Science, 21 acc. to Google Scholar). He is also an Associate Editor of Journal of Hearing Science and an Nowa Audiofonologia. He is a reviewer of 44 national and international scientific journals.

He executes numerous national and international projects connected with telemedicine, e-health, including teleconsultations, telerehabilitation and telefitting in the numerous European, Asian and African countries. He coordinates and manages the multifaceted telefitting procedures on the frame of International Centre of Hearing and Speech Medincus, collaborating with agencies in Poland and abroad.  He is also a member of researching and working group of Nationwide Network of Teleaudiology (NNT).

Research interests: ENT surgery, otology, rhinology, hearing implantable devices and hearing aids, telemedicine and e-Health, robotics, tinnitus, hearing screening in Europe, Africa, Asia and South America.

Magdalena Beata Skarżyńska, PhD

Iwona Tomaszewska-Hert, MSc

Kamila Renke, MSc

Karolina Kowalska, MSc, ENG.

Monika Huczuk, MSc

 

Kajetany, Mokra 7, 05-830 Nadarzyn

badania.kliniczne@csim.pl

Kamila Renke: +48 22 46 35 342

 

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