Offer of clinical trials
In the field of clinical trials, we offer:
- Conducting Phase II, III, and IV studies in the field of otorhinolaryngology and audiology, adhering to the principles of Good Clinical Practice (GCP)
- Highly specialized staff – specialist physicians, nurses, technicians, and coordinators, experienced in conducting this type of research, holding GCP certificates, and constantly improving their qualifications
- A modern hospital with a ward that allows for single hospitalization of up to 50 patients
- Possibility to expand the simultaneous number of patients on a hotel basis to 100
- Modern, fully equipped medical offices and procedural medical offices
- Blood collection point
- Professional premises meeting current requirements for the storage and archiving of medical documentation and clinical trial documentation, a hospital pharmacy department adapted for storing investigational medicinal products and meeting standards and requirements for storing medicinal substances requiring reduced temperature, and highly potent ones, with constant temperature monitoring, both in terms of maintaining proper temperatures inside the room and in its individual zones.
Learn more:
Equipment
- Lockable refrigerators with validated temperature monitoring
- ENT units
- Equipment for hearing tests: audiometric, tympanometric, otoacoustic emission tests as well as Brainstem Auditory Evoked Response (ABR) testing
- Equipment for vestibular disorders diagnosis: VEMP, vHit, VNG with ENG
- Stroboscopic equipment for voice organ testing
- Centrifuges, blood pressure monitors, medical scales
- ECG with automatic report generation
- Equipment for resuscitation
- Cardiac monitors, pulse oximeters
- Infusion pumps, certified refrigerator thermometers
- As well as full office equipment: fax machines, scanners, printers, etc.
All equipment used on site is certified, has required device passports, and comes with valid manufacturer/service warranties.
Organizational structure of the clinical research site
- Lead Researcher (responsible for the study, with experience in conducting clinical trials according to ICH GCP standards and applicable local requirements and legal regulations)
- Team of co-researchers – selected individually, depending on the needs of the trial, consisting of doctors with expertise corresponding to the therapeutic field within which the clinical trial is conducted
- Nurses with IATA and GCP certificates, many years of experience, and competent in cooperation with laboratories and courier companies transporting biological material
- Pharmacists trained in GCP guidelines
- Experienced coordinators with specialized education in conducting and monitoring clinical trials and numerous IATA, GCP certificates, proficient in operating eCRF and electronic drug management systems in the center – IVRS/IWRS. The tasks of coordinators also include, among others, collecting and maintaining source documentation for clinical trials and center documentation.
Standards
In our work, the well-being and safety of the patient are paramount – ensuring that their participation in a clinical trial complies with the guidelines of Good Clinical Practice. In accordance 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 within the realized project outweigh the possible risks. Hence, our team of experienced specialists continuously monitors the health status of participants in ongoing clinical trials to quickly identify the occurrence of any adverse events.
Regarding administrative activities for clinical trials, we can provide:
- Coordination and execution of projects by experienced researchers, fluent in English
- Diligence in maintaining medical documentation
- Data entry into the CRF system
- Supervision of the trial’s progress and patient visit schedules
- Collaboration with clinical trial monitors
- Responding to queries and resolving any discrepancies
- Supervision of investigational medicinal drugs located in our Center
When performing clinical trial-related tasks, as a team we adhere to the following standards:
- Feasibility guarantee – undertaking the execution of specific studies/projects, we always complete them successfully, and if needed, after prior consultation with the Sponsor, we introduce necessary modifications
- Diligence – every study/project is a priority for us and we carry it out with the utmost care and dedication, having the feeling that our work can contribute to the development of the medical industry
- Timeliness – information related to the progress of a given study/project is always delivered on time
- Knowledge and experience – we possess appropriate competencies and experience in conducting clinical trials; moreover, we eagerly undertake expanding our knowledge through participation in conferences and reading professional literature
- Commitment – we treat every study/project individually and devote appropriate attention to it, meticulously fulfilling our duties
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 centers