Clinical trials drugs for USA, Canada, Germany in Ukraine | Phas

[https://trials-cdc.com] HOME ABOUT US SERVICE ETHICS COMMITTEE ADVANTAGE 3D TOUR CONTACT ARTICLES Clinical and Diagnostics Center Contact • The results are accepting by EMA & FDA • EMA audit was conducted • Results get faster • Easier to find volunteers • World-class quality 3D tour Clinical and Diagnostics Center Clinical and Diagnostics Center was established in 2000 as a subdivision of National University of Pharmacy (NUPh). It functions according to Medical Practice License and is regulated by “The Statute of Clinical and Diagnostics Center of NUPh” which was approved by the Ministry of Health of Ukraine. Clinical and Diagnostics Center of NUPh was accredited as the medical and prophylactic establishment of the highest category by the Head of accreditation committee of the Ministry of Health of Ukraine. It was also approved by the Resolution of Cabinet of Ministers No 501 from 16 May 2011 in the list of the healthcare establishments and programs which provide the fulfillment of state functions.In Clinical and Diagnostics Center there was founded the local ethical committee which works in a strict accordance with the requirements of the Ukrainian legislation and international rules of ICH GCP. We have gained wide experience in carrying out Phase I−IV trials and bioequivalence studies of drugs. We collaborate both with national manufactures and foreign companies from the USA, Great Britain, Germany, France, Sweden, Switzerland, Spain, Latvia, Poland, Croatia, Russia. "Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)". ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1 Read more CERTIFICATES See all our certificates Phase I-IV Clinical trials Clinical and Diagnostics Center of National University of Pharmacy (NPhU CDC) offers the services for Phase I-IV clinical trials. Our professional staff with many years of experience is ready and in time will cope with all assigned tasks. BIOEQUIVALENCE STUDIES Clinical and Diagnostics Center of National University of Pharmacy (CDC NPhU) offers services for bioequivalence studies. Clinical and Diagnostics Center of National University of Pharmacy conducts high-grade bioequivalence studies. In our center, it is also possible to consult on specific issues, or have a complete examination.. Our experienced professional staff is always ready to help you and in time will cope with all assigned tasks. Contact us at your convenience - contacts . SERVICE Phase I-IV Clinical trials Statistical research Training on GCP Bioequivalence studies Igor A. Zupanets Under the leadership of Prof. Zupanets there were defended 5 doctoral theses and 20 PhD theses. As a result of scientific establishment research there were created more than 22 drugs which are now on different stages of marketing introduction. At the site there were conducted more than 50 trials of Phase I−IV and bioequivalence studies of drugs as well. 5 DOCTORAL THESES 24 PhD THESES 22 DRUGS WERE CREATED Medical staff Clinical and Diagnostics Center is equipped with the diagnostic facilities The investigational team of Clinical and Diagnostics Center includes 3 Doctors of Medical (Pharmacy) Sciences, 9 PhD, 4 MD Investigators and 6 trial nurses. All investigators and trial nurses were certified for the highest qualification category. The resuscitation specialists and clinical pharmacists are also included in the staff. Altogether there are 26 persons. The study coordinator provides the coherence of the trial, and quality-control specialist is responsible for the quality of procedures. All investigators have passed clinical trials training courses and have got GCP certifications. "Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)." ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1 Equipment Clinical and Diagnostics Center is equipped with the diagnostic facilities which are necessary for the clinical trials. During clinical trial of drug formulations «Terumo» Japan infusion pumps with the programmed regimen of intravenous drug infusion are used. Samples of blood plasma are separated in the refrigerator centrifuges «MPW 350R» and placed in the prelabeled tubes. The frozen blood and urine samples are stored at −80 °C in the refrigerator «JOUAN» before their shipment to the pharmacokinetic laboratory. This facility is additionally equipped with the system of back-up power supply. There are also two additional refrigerators with the temperature range from −20 °C to −80 °C. The samples of biological duplicates are stored at least 1 year after the end of the study. Clinical and Diagnostics Center has its own certified clinical laboratory which is equipped with the modern laboratory facilities capable to determine the basic laboratory tests very quickly. "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification." ICH Topic E 6 (R1) Guideline for Good Clinical Practice, Section 2.1 Send us a message Your name Your e-mail Message About us Service Advantage 3d Tour Poland 05-270 Marki Ul. Graniczna 30 C/1 ianadiakonovaiana@yandex.ua Yana Diakonova Canada 7223 Croissant du Littoral Anjou (QC) H1J3A6 roma@bazulevych.com Roman Bazulevych USA 11 Saint Mary avenue NJ 08050 Manahawkin Serggrachev@hotmail.com Grachev Sergey 609-978-3287 Home 609-618-8074 Cell Contact Contact us: +38 (067) 917 42 73 +38 (057) 706 30 59 +38 (057) 706 30 72 Write us: igorzupanets@gmail.com Ukraine 27, Pushkiskaya str, Kharkiv, 61057 Find us here: © 2018 Clinical and Diagnostics Center. All Rights Reserved. Clinical and Diagnostics Center cможет принять любую посещаемость благодаря кешированию WP Super Cache