Centrum Badań Klinicznych PI-House sp. Z o. O. Conducts outpatient clinical trials in many indications. We stay in touch with doctors of many specialties, and depending on the specifics of the tests proposed to us, we establish cooperation with new doctors. This also applies to specialist consultations and diagnostics.
FOR Sponsors and CRO
Outpatient clinical trials in cooperation with doctors with extensive experience in conducting clinical trials.
We are good in recruitment
The PI-House Clinical Research Center is a center conducting outpatient Clinical Trials founded and run by doctors with extensive experience in conducting clinical trials. During the current period of our activity, we have ended 92 clinical trials, currently 31 trwających (15 z zamkniętą rekrutacją, 16 z otwartą rekrutacją). Prowadziliśmy badania w następujących wskazaniach: cukrzyca, hipercholesterolemia, zawał serca, astma, łuszczyca, atopowe zapalenie skóry, łuszczycowe zapalenie stawów, reumatoidalne zapalenie stawów, epilepsja, choroba Parkinsona, stwardnienie rozsiane, ślinotok, leczenie bólu, depresja osób dorosłych i osób starszych, schizofrenia, ADHD, badania szczepionkowe.
To date, nearly 1200 participants. Average percentage participants have participated in all clinical trials. The average “screen failure” percentage is 26% for all tests in our center. The average “drop-out” percentage is 6% for all tests in our center.
We cordially invite you to personally familiarize yourself with the Center for Clinical Research PI-House. We will gladly answer all your questions.
Drop - out
Recruitment at CBK PI-House
In many studies we have achieved first place in recruitment on a Polish scale, in a dozen or so on a global scale:
Psychiatry: in the MDD indication - 1 study with the first place in the world despite a twice short recruitment period than the USA; 4 tests - first place in recruitment in Poland. In the indications schizophrenia, bipolar disorder and ADHD; after one study with the best recruitment in Poland.
Diabetology: 5 studies with the best recruitment in Poland, and one on the world scale.
Rheumatology: we are among the most effective recruiting centers in Poland.
Dermatology: we are also among the most effective recruiting centers in Poland.
We are currently implementing new recruitment methods that aim to significantly expand the population of Research Participants, also in other areas.
Recruitment of participants for Research takes place through their own databases of doctors acting as Researchers and through a network of cooperating doctors, which thanks to a large database is a significant recruitment tool.
Our ambition is to further develop effective recruitment and to this end we implement new methods to significantly expand the population of research participants. We use our own internet tools as well as use portals provided by Sponsors. We are constantly working with POZ and specialist clinics in the Tri-City. In addition, we are increasing the number of clinics run by us as a therapeutic entity.
Currently available in our clinics: Diabetology, Mental Health, Health Promotion and Geriatric.
In our Center we make every effort to provide monitors with comfortable working conditions.
Wi-Fi is available throughout the resort, and there is a photocopier with scanning on each floor. If necessary, we provide assistance in the field of office work (scanning, photocopying, professional destruction of documentation)
We guarantee the presence of a researcher or coordinator during monitoring visits.
The secretariat works on business days from 7:00 to 18:00, but the Center in exceptional situations adapts to the working hours of both the researcher and the monitor.
You can order a courier or parcel, all you have to do is submit a request to the secretary's office.
On both levels there are social rooms, in which there is a coffee, tea corner and kitchen equipment. The secretariat will help You with ordering lunch or dinner.
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 the introduction of functionality that will enable remote data verification in the future.
Our facilities include a waiting room with a tea and coffee corner and a TV set. Research participants can spend their time here waiting for a visit or the next test procedures. A toilet adapted for the disabled is located nearby. We have experience in organizing meals for Research Participants in accordance with the Sponsor's requirements and in organizing transport (taxis, medical transport). We also have procedures that allow participants to efficiently obtain reimbursement for travel expenses for study visits.
We run a Diabetes, Psychiatric, Geriatric Clinic, as well as a Health Promotion Clinic. Therefore, many Research Participants are also directly under our care outside of the research.
We are constantly expanding our research offer to be able to gather not only specialists of many specialties in one place, but also provide consultation of external specialist doctors, psychologist's advice, dietitian and various trainings.
At the PI-House Clinical Research Center we take care of the Research Participants!
Our center has experience in working with central and local diagnostics.
-Laboratorial: Quintiles, Covance, Medpace, ICON, ACM global, LKF, Quest Diagnostics
-EKG: ERT, CARDIOCORE
We have cooperation agreements with units that perform imaging tests, such as X-ray, ultrasound, CT, MRI, diagnostic tests (gastroscopy, colonoscopy) and an analytical laboratory. If necessary, we establish cooperation with other necessary external medical units. We are able to rent equipment we do not have and provide technicians who are required. In the case of demand for equipment that we do not have in the study, we are also considering the possibility of buying it.
We work with doctors of many specialties who act as researchers in research teams or carry out specialist consultations. Researchers have many years of professional experience in their fields. New Chief Researchers always have research experience at least as co-investigators. All doctors who are members of the team have GCP & #8211 certificates; we monitor their timeliness. In accordance with the Sponsor's requirements, each study involves physicians experienced and trained in performing scales and assessments specific to a given specialty and examination.
Research Coordinators are an important element of the research team. They supervise the organization of research in our center, support Researchers in operating systems (IWRS, EDC), take care of the medicine and dispatch of samples. The team of coordinators is completed 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).
The auxiliary staff employed in clinical trials are nurses, nurses and a laboratory worker, whose work is managed by the Coordinator. The staff is trained in resuscitation, has GCP and IATA certificates, renewed every 2 years. We have nurses who have completed the vaccination course. A large number of staff allows you to easily divide the team into blinded and blinded, if required by the Sponsor.
The administration team completes the work of our Center. The Secretariat carries out numerous activities necessary for the efficient conduct of clinical trials, such as handling received and sent shipments, ensuring the validity of equipment certificates, ensuring timeliness of non-specific training for the study, such as GCP and IATA, providing the necessary office supplies, etc., etc.
Directing participants who come to the center to the appropriate researcher, caring for patients awaiting examination procedures.
Coordinator of the Center
He supervises the tasks of the Secretariat regarding clinical trials, is responsible for the availability and training of auxiliary staff, correctness of nursing and laboratory procedures, maintaining the temperature of biological samples, test substances and medicines, for telephone and internet communications 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 as well as with separate, closed cabinets for documentation of individual tests. We have offices for blood collection and vaccination, and a nurse's office. These offices, equipped with certified equipment, are prepared for the collection, processing and packaging of biological samples.
The room dedicated to tested substances meets all safety standards: no windows, no water lines, lockers and a safe intended for narcotic and psychotropic substances, whose storage in our center is under the supervision of the Provincial Pharmaceutical Inspectorate.
Our facilities also include a waiting room for patients with a coffee and TV service, and a sanitary facility adapted to the needs of the disabled, and for the staff & #8211; two sanitary facilities, including a shower, stove, social room.
Safety is our top priority
The entrance 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-burglar blind, the center is connected to an alarm system monitored by a certified company, windows located on the ground floor, all, without exception, are secured with bars.
We meet the standards of fire protection, disinfection, disinfestation and deratization, medical waste disposal, including test substances. In each of these areas, we remain under the documented control of relevant authorities.
We also have our own power generator in the event of power outages, of which we are notified by an automated SMS system. Automatic SMS notifications & #8211; we also receive in the event of a threat of exceeding the set room temperature (with monitored access) for storage of IMP. We have appropriate internal procedures ensuring quick intervention in the case of the above-mentioned threats.
After the clinical trial is completed, the documentation is stored in the 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,
– ECG apparatus (own and central from the Sponsor),
– blood pressure monitors
- ankle-brachial index (ABPI)
- HbA1C analyzer
In all places where temperature control is required (refrigerators, freezers, a room dedicated to the test substances), temperature measurement is carried out using minimum-maximum thermometers on weekdays in the form of a central temperature log.
All the equipment we have is under constant technical control, which is confirmed in the technical passport or in the form of measurement certificates.
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,
- Medoc Q-sense
- CGM / FGM sensors
- HbA1C analyzer
- infusion pumps
We also work with various patient materials such as glucometers and e-diaries.
Besides we also have experience with web portals that support the above equipment such as ERT, Cardiocore, PHT, SWEETSPOT, TRIALMAX.
We have experience in storing test substances (tablets, subcutaneous injections, vaccines) as well as biologically active substances under various temperature conditions. They are stored in a room dedicated to test substances, which meets all safety standards: no windows, no waterways, lockers. We also have a safe designed for narcotic and psychotropic substances, whose storage in our center remains under the supervision of the Provincial Pharmaceutical Inspectorate.
The supply of electricity, in the case of a supply break, in refrigerators and freezers, is provided by its own spare power generator. We are informed about the interruptions in the delivery of the automated SMS system. We are also automatically notified of the risk of exceeding the set temperature in the storage room of the IMP.
We have our own procedures (SOPs) for controlling the temperature and preventing its set values from being exceeded.
In the room where the test substances are stored, the temperature is measured daily (from Monday to Friday) using minimum-maximum thermometers.
We have been called 'Virtual Trial Capable', which means that the PI-House Clinical Research Center is ready for decentralized testing (DCT).
audits at the PI-House Clinical Research Center
So far 14 audits from the level of pharmaceutical companies and CROs and one URPL inspection have been carried out in our center.
On November 11, 2017, our center was accredited by TransCelerate BioPharma to conduct certified training in Good Clinical Practice (GCP). Thus, CBK PI-House joined