Co-operation
Co-operation with Klinika Badawcza is a guarantee of highest standards in conducting clinical trials. Our advantages are an efficient recruitment system, accuracy, diligence and meeting deadlines. The clinical research centre itself is modern and meets all requirements. We guarantee high quality of clinical trials. Your contact is warmly welcome!
Our physicians are researchers of numerous specialties who have experience in conducting clinical trials or research work as sub-investigators. They hold valid GCP certificates and are able to fill in the dedicated scales and evaluations specific for the project. In case of emergency, they are on a night duty with the patient.
Clinical trial co-ordinators are the team members who have a long-standing practical experience and thanks to them our Klinika Badawcza activities are of highest standards. They hold valid GCP and YATA certificates, support the researchers and patients. They handle the EDC databases (Oracle, InForm, Medidata rave, BMS-TAO, DATATRACK, MACRO, etc.), as well as IWRS/IVRS systems (ERT, Clinphone, Almac, Medpace IVRS, Bracket), central laboratories (Covance, Quintiles, ICON, ACM, Quest diagnostic, Bioclinica, Synarc) and dedicated Web portals. They look after the participants and direct them to the appropriate researcher.
Administrative personnel carries out all the necessary activities needed for conducting research and administration of our Klinika Badawcza. Their duties include checking validity of equipment certificates, collecting and posting letters or parcels, as well as handling office supplies.
Nurses and laboratory technicians have both the necessary knowledge and experience in co-operating with the central diagnostics institutions. It is obligatory for them to hold valid GCP and YATA certificates renewed every two years. They are trained in resuscitation and also create a blinded or unblinded team if required.
The equipment of Klinika Badawcza
Klinika Badawcza is equipped with high quality certified devices such as:
- lockable 2-8°C refrigerators with sole access by authorised members of the research team
- centrifuges with and without the cooling option
- incubator
- weighing scales with height rod
- ECG machine
- sphygmomanometers
- min/max thermometers
- defibrillator
- IMP storage cabinets
- zamrażarki -20°C
- zamrażarki -70°C
- spirometr
The condition and reliability of the devices is confirmed in their technical passports. Our clinical research centre also has an internal temperature log, which may be added to research documentation.
Other information about the clinical research centre
Klinika Badawcza is registered as a medical entity. It is a modern clinical research centre which meets the requirements for conducting research of highest standards. The institution is under constant supervision of Sanitary-Epidemiological Office. We offer the use of doctor’s surgeries, treatment rooms, clinical trials monitoring rooms as well as a room for storing medicines and documentation accessible only for the personnel. Klinika Badawcza is equipped with a high quality security system, backup power supply and access to the Internet. We enable sending faxes as well as the use of the photocopier; and to our patients we offer comfortable waiting-rooms. The sanitary units are adjusted to the needs of the disabled.
High standards of waste and substance disposal are documented by the proper institutions.
Co-operation with our Klinika Badawcza is a guarantee of highest standards - experienced medical personnel.
Recruitment of trial participants
In the process of recruitment, we use our own database as well as the database of co-researchers who participate in the project. Our Internet tools and the ones which the Sponsor makes available allow us to improve the patient recruitment procedure. We also co-operate with Primary Health Care clinics (both state and private ones) and private medical practitioners in several provinces: Pomerania, Kuyavia – Pomerania and Warmia-Masuria. Thanks to that, we have access to an extensive database and the possibility to help a great number of patients.
Standards of Klinika Badawcza
Our long-standing experience has enabled us to see to details, time and commitment in particular research projects. Drawing from our practice, we created our own standards of work – Standard Operation Procedures, which concern:
- archiving the research documentation according to protocol and GCP
- storage of the examined medicine and of biological samples, monitoring their temperature and standards of action in case the temperature limit is exceeded
- quick, correct and reliable process of recruitment of patients
- evaluation of qualification of the patient for participation in trials, checking the medical record, conducting an interview with the patient
- keeping and storing medical documentation
- conducting trainings by a given project team
- updating certificates
Commencement of trials is important both for our Sponsor and for the patients, which is why the process of negotiating contracts and signing them is handled by our medical lawyer who is at your disposal during our clinical research centre working hours.
We have emphasised many times that in our Klinika Badawcza, the wellbeing of the patient is of utmost importance and this is why we do our best to ensure comfort for the subjects. A comfortable modern waiting-room is helpful while waiting for the second blood sample to be taken, waiting for medicines to be dispensed or filling in questionnaires. Our personnel take care of meals, arrange transport and reimburse travel expenses. Also, our patients may take advantage of a 24-hour contact with specialists and co-ordinators.