Our research teams have experience and actively participate in remote monitoring. At the moment, the center is working on the implementation of electronic source documentation and on the introduction of functionalities that will enable remote data verification in the future.

Researchers

We work with doctors of many specialties who act as researchers in research teams or perform specialist consultations. Researchers have many years of professional experience in their fields. New Principal Investigators always have experience in conducting research at least as co-investigators. All doctors who are members of the team have GCP certificates - we monitor their validity. In accordance with the Sponsor's requirements, each study involves doctors who are experienced and trained in making scales and assessments specific for a given specialty and study.

Coordinators

Research Coordinators are an important part of the research team. They supervise the organization of research in our center, support researchers in the use of systems (IWRS, EDC), take care of the drug and ship samples. The team of Coordinators is complemented by the Center Coordinator, which is an organizational bridge between the activities of support staff and researchers. All coordinators have valid GCP and IATA certificates.

Both Researchers and Coordinators have experience in handling electronic databases (Inform, Medidata), IWRS systems (ERT, Clinphone, Almac, Suvoda, Lilly IWRS, Medpace IWRS, Bracket), support central diagnostics (Quintiles, Covance, Medpace, ICON , ACM global, LKF, Quest Diagnostics, SYNARC, Bioclinica), equipment received from the Sponsor and dedicated websites (ERT, Cardiocore, PHT, SWEETSPOT, TRIALMAX).

Support Staff

The auxiliary staff employed in clinical trials are nurses, nurses and a laboratory assistant, whose work is managed by the coordinator. The staff is trained in resuscitation, GCP and IATA certified, renewed every 2 years. Our team includes nurses who have completed the vaccination course. A large number of staff allows you to easily divide the team into blinded and unblinded, if this is the Sponsor's requirement.

Secretariat

The work of our Center is completed by an administrative team. Secretariat, performs numerous activities necessary for the efficient conduct of clinical trials, such as: handling received and dispatched parcels, ensuring that equipment certificates are up-to-date, ensuring the timeliness of non-specific training courses, such as GCP and IATA, providing the necessary office supplies, etc., e.t.c.

Coordinator of the Center

Supervises the tasks of the Secretariat regarding clinical trials, is responsible for the availability and training of auxiliary staff, the correct performance of nursing and laboratory procedures, maintaining the proper temperature of biological samples, test substances and drugs, for telephone and internet communication, and for the efficiency and availability of equipment used in clinical trials .

The center covers an area of about 600 m2. We have 5 doctor's offices and 12 offices with office equipment, computers and Internet access, and with separate, lockable cabinets for documentation of individual examinations. We have offices for blood collection and vaccination as well as a nursing office. These offices, equipped with certified equipment, are prepared for collecting, processing and packaging biological samples.

The room dedicated to the test substances meets all safety standards: no windows, no water lines, lockable cabinets and a safe for narcotic and psychotropic substances, the storage of which in our center is under the supervision of the Provincial Pharmaceutical Inspectorate.

Our facilities also include a waiting room for patients with coffee and TV service and a sanitary facility adapted to the needs of the disabled, and for staff - two sanitary facilities, including a shower, a kitchenette, and a rest room.

Safety is our top priority

Access to the center, as well as to each of its two levels (ground floor and first floor), is coded. The entrance to the center is secured by double doors and anti-burglary roller blind. The center is connected to an alarm system monitored by a certified company. The windows on the ground floor are all secured with bars without exception.

We meet the standards of fire protection, disinfection, disinfestation and deratization, disposal of medical waste, including test substances. In each of these areas, we remain under the documented control of the relevant authorities.

We also have our own power generator in case of power outages, of which we are notified by an automated SMS system. Automatic SMS notifications - we also receive in the event of a risk of exceeding the set temperature in the room (with monitored access), for storage of the IMP. We have appropriate internal procedures to ensure quick intervention in the event of the above-mentioned threats.

After completion of the clinical trial, the documentation is kept in an archive with limited, monitored access, controlled temperature and humidity, under the control of a flood detector.

– 2-8 ° C refrigerators,
– freezer -20 ° C,
– freezer -80 ° C,
– centrifuge with cooling,
– centrifuge without cooling,
– thermostat,
– weight,
– increaseometer,
– ECG apparatus (own and central from the Sponsor),
– blood pressure monitors
- ankle-brachial index (ABPI)
- HbA1C analyzer
- polysomnograph 

In all places where temperature control is required (refrigerators, freezers, room dedicated to test substances), temperature is measured using minimum-maximum thermometers, on working days in the form of a central temperature log. 

Certifications

All the equipment we have is under constant technical control, which is confirmed in the technical passport or in the form of measurement certificates.

Experience

We have experience in working with equipment received from the Sponsor:
– ECG – with a special wardrobe for their storage
- laptops, tablets and diaries: e-Site pady, e-PRO, e-diaries,
– spirometer
- Fibroscan
- Medoc Q-sense
- CGM / FGM sensors
- HbA1C analyzer
- infusion pumps

We also work with various patient materials, such as blood glucose meters and e-diaries.
Thus, we also have experience with internet portals that support the above devices, such as: ERT, Cardiocore, PHT, SWEETSPOT, TRIALMAX.