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 tests. Established and run by doctors with many years of experience in conducting clinical trials. During the current period of our activity, we have finished 100 clinical trials. We are currently running 31 research (15 with closed enrollment, 16 with open enrollment). We have conducted research in the following indications: diabetes, hypercholesterolaemia, heart attack, asthma, psoriasis, atopic dermatitis, psoriatic arthritis, rheumatoid arthritis, epilepsy, Parkinson's disease, multiple sclerosis, drooling, pain treatment, depression in adults and the elderly, schizophrenia , ADHD, vaccine research.

We cordially invite you to personally familiarize yourself with the Center for Clinical Research PI-House. We will gladly answer all your questions.

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 indication MDD;
    1 study with the first place in the world despite twice the recruitment period than the USA.
    4 studies with the 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,
    1 survey in the first place worldwide.
  • 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.

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.

Research participants are recruited through their own databases of doctors who act as Researchers and through a network of cooperating doctors, which, thanks to a large database, is a significant recruitment tool. In addition, we have our own Recruitment Department dealing with patient acquisition.

Our ambition is to further develop effective recruitment and to this end, we implement new methods aimed at significantly expanding the population of research participants. We use our own internet tools, as well as use portals provided by Sponsors. We constantly establish cooperation with POZ and specialist clinics in the Tri-City. We work with the senior community and City Halls. We are increasing the number of clinics run by us as a medical 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.

There is a Wi-Fi network available throughout the resort. There is a photocopier with a scanning function on each floor. If necessary, we provide assistance in the field of office work (scanning, photocopying, professional document destruction)

We guarantee the presence of a researcher or coordinator during monitoring visits.

The secretariat works on working days from 7:00 to 18:00. In exceptional situations, the center adjusts 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 with a coffee and tea corner and kitchen equipment. The secretariat will help you order 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 on the introduction of functionalities that will enable remote data verification in the future.

Our facilities include a waiting room with a coffee and tea corner and a TV. Research participants can spend time here in peace, waiting for an appointment or for the next test procedures. There is a toilet nearby, adapted for the disabled. 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 enable the Participants to efficiently obtain reimbursement of travel expenses for study visits.

We run a Diabetes, Psychiatric and Geriatric Clinic, as well as a Health Promotion Clinic. Therefore, many Research Participants remain under our direct care also outside of the research.

We are constantly expanding our research offer in order to be able to gather in one place not only specialists of many specialties, but also to provide consultations with external specialist doctors, psychologist advice, dietitian and various training.

At the PI-House Clinical Research Center we take care of the Research Participants!

 

We have cooperation agreements with units that perform imaging tests, such as X-ray, ultrasound, CT, MRI, FibroScan, PET, 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 that we do not have and provide technicians that are required. If there is a need in the study for equipment that we do not have, we also consider the possibility of buying it.

 

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.

We have experience in the storage of test substances (tablets, subcutaneous injections, vaccines) as well as biologically active substances under various temperature conditions. They are stored in a room dedicated to the test substances that meets all safety standards: no windows, no waterways, closed cabinets. We also have a safe for narcotic and psychotropic substances, the storage of which in our center is 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.

CBK PI-House Member of the SCRS

Ladies and gentlemen! We are pleased and proud to announce that PI-HOUSE has been accepted to the Society for Clinical Research Sites (SCRS), a global association of clinical research centers,

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Quality first!

We are pleased to announce that CBK PI-House has once again successfully passed the audit and obtained the PN-EN ISO 9001: 2015 certificate in the field of "Organization of clinical trials, medical services

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