Clinical trial offerings
In terms of clinical trials, we offer the following:
- Conducting Phase II, III and IV studies in otorhinolaryngology and audiology, guided by the principles of Good Clinical Practice
- Highly specialized staff – specialist doctors, nurses, technicians and coordinators, experienced in conducting this type of research, certified by GCP, and constantly improving their qualifications
- A state-of-the-art hospital with a department that allows up to 50 patients to be hospitalized at a time
- Ability to expand the simultaneous number of patients on a hotel base to 100
- State-of-the-art, fully equipped medical offices and treatment rooms
- Blood collection point
- Professional premises, meeting the current requirements for the storage and archiving of medical records and clinical research records, hospital pharmacy department, suitable for the storage of investigational medicinal products, and meeting the standards and requirements for the storage of medicinal substances requiring reduced temperature, and highly active, with constant temperature monitoring, both in terms of maintaining the correct temperatures inside the room and in its various zones
Learn more:
Equipment
- Lockable refrigerators with validated temperature monitoring
- ENT unites
- Hearing test equipment: audiometric, tympanometric, acoustic otoemission and ABR brainstem response tests)
- Imbalance testing equipment: VEMP, vHit, VNG along with ENG
- Equipment for stroboscopic testing of the voice organ
- Centrifuges, blood pressure monitors, medical scales
- ECG with option for automatic generation of recording description
- Equipment for performing resuscitation
- Cardiac monitors, pulse oximeters
- Infusion pumps, certified refrigerator thermometers
- And full office equipment, fax machines, scanners, printers, etc.
All equipment used at the center has the required equipment passports and a current manufacturer/service warranty.
Organizational structure of the center
- Principal Investigator (a physician who is responsible for the study in question, with experience in conducting clinical trials according to ICH GCP standards and applicable local and regulatory requirements)
- Team of Co-Investigators – selected on an individual basis, depending on the needs of a particular project, consisting of physicians with a specialty corresponding to the therapeutic area within which the clinical trial is conducted
- Nurses with many years of experience certified by IATA, GCP, with experience in cooperation with a number of laboratories and courier companies, transporting collected biological material
- Pharmacists trained on GCP
- Experienced coordinators with faculty training in conducting and monitoring clinical trials and multiple IATA, GCP certifications, fluent in eCRF and electronic site drug management systems – IVRS/IWRS.
Coordinators’ responsibilities also include, but are not limited to, collecting and maintaining clinical trial source documentation, and site documentation
Standards
In our work, the most important thing for us is the well-being and safety of the patient – that their participation in the clinical trial is in accordance with the guidelines of the so-called “Good Clinical Practice.
Good Clinical Practice.
In accordance with these standards, we also ensure that the patient fully understands all aspects of participation in the clinical trial and that the benefits of treatment under the ongoing project outweigh the possible risks.
Hence, our team of experienced specialists monitors the health status of participants in ongoing clinical trials on an ongoing basis to quickly identify the occurrence of possible side effects.
Regarding the administrative activities related to clinical trials, for our part we can provide:
- Coordination and implementation of projects by experienced researchers, fluent in English
- Diligence in maintaining medical records
- Completion of data in the CRF system
- Supervision of the study and patient visit schedule
- Collaborate with clinical trial monitors
- Responding to so-called
queries and clarify any inconsistencies that arise - Supervision of investigational drugs, located in our Center
We are guided by the following standards when performing clinical research tasks as a team:
- Guarantee of feasibility – when undertaking specific studies/projects, we always complete them successfully, and if necessary, after prior consultation with the Sponsor, we make the necessary modifications
- Conscientiousness – each study/project is a priority for us and we carry it out with the utmost care and dedication, feeling that we can contribute to the development of the medical industry with our work
- Timeliness – we always provide information related to the progress of a given study/project within the allotted time frame
- Knowledge and experience – we are competent and experienced in conducting clinical trials, moreover, we are eager to expand our knowledge by attending conferences and reading professional literature
- Commitment – we treat each study/project individually and pay adequate attention to it, scrupulously fulfilling our responsibilities
We cordially invite you to start working with our team!
Anyone interested, please contact us:
Phone numbers do not apply to appointments and hearing tests at MEDINCUS clinics