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Centrum Badan„ Klinicznych PI-House sp. z o.o. is fully committed to conduct clinical trials. Perfect quality of our services is based on cooperation with over thirty clinicians of various specialities and highly experienced research staff. We are able to run trials in psychiatry, diabetology, neurology, rheumatology, dermatology, pulmonology, gastroenterology, urology, pain treatment and sleep disorders as well as studies for paediatrics population specifically in area of psychiatry, neurology and vaccines.

Area of 600 m2 occupied by PI-House meets all the requirements for clinical researches purposes. That includes consulting rooms, treatment room, laboratory, specialised room for investigational product storage and perfectly adapted archiving place that all fulfil safety requests. The whole area is under safety control (bars on windows, motion sensors, coding entrance, double door and alarm connected to external security company), fire protection and energy back-up that automatically sends a text message in case of energy outage. Temperature monitoring in the IP storage room, fridges and freezer is provided by use of min/max thermometers, Monday to Friday temperature logs and alarm that in case of excursion sends a text message. Still, we are planning to obtain -70stC freezer in the nearest future. Internal SOPs improve everyday function of the site and provide training for new researches. Radio-controlled clocks ensure perfect time uniformity over all procedures performed at our site and captured in specifically adjusted laboratory and nurse books. Waiting room for patients and social room for researchers and CRO complete the list of excellent conditions that our Site provides.

We cooperate with external facilities such as local laboratory, digital diagnostic department (CT, MRI, PET, X-RAY) and other out-patient clinic providing services not available at our site directly. Moreover polysomnography diagnostic is available at the site using certified polysomnography equipment. Any medical procedure can be outsourced as needed.

Besides clinical trials activity two out-patient clinics have place on the site: psychiatric and diabetologic. Since the verybeginning our site has been top-recruiter in psychiatry and diabetology. We are aware of difficulties in patient search so we support our researches in their efforts to ensure successful patient recruitment by different boost strategies such as external patients recruiting companies.  

Contracts and budgets negotiations at our Centre are executed fast and effectively assuring minimum length of time required for trials activation - in case of emergency from day to day. Our personnel guarantee accurate submission of documentation, targeted patient recruitment, efficient screening, enrolment and timely collection of high quality clinical data. We maintain the highest ethical and legal standards what consecutive audits proved. Our site has been audited by two Sponsors and two CROs - no major discrepancies were found.

Please visit our website: www.pihouse.pl

Web Site: www.pihouse.pl 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2011
  • Phases of clinical studiesPhase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsChild 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteFreestanding
  • # of employees involved in research10
  • # of investigators30
  • Number of studies last year12
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL, Other
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsHanna KuĊ›mierek
  • Regulatory phone number+48730201222
  • # of days to turn around regulatory documents14
  • Type of IRB used by this siteCentral, Local
  • How often does your local IRB meet?Monthly
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract14

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