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 Qualia’s 160 bed, 33000 square foot clinical research facility in Omaha, Nebraska is staffed with a highly-trained, and dedicated contingent of clinical research professionals having focused expertise in Phase I clinical research. The Omaha facility is located in a quiet, well-kept business park area in south Old Mill, approximately 3 miles from Methodist Hospital.This state-of-the-art facility includes four Bioavailability/Bioequivalence study clinics, Phase I clinic, separate recruitment area, administrative offices, sample processing area, treatment rooms, kitchen, cafeteria, physicians’ offices, and pharmacy. Omaha metropolitan area is home to University of Nebraska in Omaha and Creighton University, and few other area colleges. The Omaha metro boasts a combined enrollment of nearly 100,000 students, and a demographically diverse population of close to 1,000,000. Omaha is a highly regarded community for clinical research activity in the U.S. due to an abundance of top quality hospital and medical centers such as the University of Nebraska Medical Center, Creighton Medical Center, Boys Town National Research Hospital, Methodist Hospital, Immanuel Medical Center and several other major hospitals in the metropolitan area. There is a total of 9 hospitals and 3 medical centers in Omaha. Due to strong focus on research in Omaha, study participants are typically knowledgeable, reliable and compliant with study requirements and very familiar with the concept of clinical research. USA Today reported Omaha as one of the Top-10 cities in USA with home to the highest number of Fortune 500 companies’ corporate headquarters. Omaha was also recognized as one of the best cities in the nation to do business because of people’s high work ethic, values and commitment to success. Qualia United States
Omaha Phase I Clinical Site
10845 Harney Street
Omaha, Nebraska
68154, USA
Tel: 402.697.6500
Visiting Omaha? Please follow this link to a map of hotels, restuarants and more.
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Toll Free: 1.866.629.7100
bd@qualiaclinical.com |
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 Qualia has a concentrated effort in Phase II-IV clinical trial management services in Toronto, Canada. In addition to clinical facilities, the Toronto offices also house Qualia's experienced Data Management team. This team can effectively serve clients and help reduce the number of contacts for each trial.
The Toronto clinic has been active in patient clinical trials for the last two years and has successfully conducted numerous clinical studies. During this period Qualia has developed a large database of patients and network of referring physicians and specialists.
Qualia has unique experience in conducting large single site studies for specialized therapeutic areas. Recently we have successfully completed a single center study with over 140 subjects for ADHD. Qualia has a 3,000 sq ft clinic in Toronto, Canada providing the sponsor comprehensive clinical research and support. From project management to patient care and report writing, we have dedicated experience staff of the highest quality.
Qualia can also assist with planning, managing and monitoring the center trial in Phase II through IV of the drug development. Our physician network and cross-border presence allows us to establish sites and recruit subjects, ultimately contributing to the success of your study.
Qualia Canada
Toronto Clinical Site
220 Dundas Street West, Suite 402
Whitby, Ontario
Canada
L1N 8M7
Tel: 905.430.9873 |
Toll Free: 1.866.629.7100
bd@qualiaclinical.com |
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 Qualia Europe is a contract research organization (CRO) offering full-scale clinical trial support for Phases II-IV to pharmaceutical companies interested in conducting clinical trials in Ukraine and Central Europe.
Headquartered in Kiev, Ukraine, our complete clinical trial service and logistical support removes the barriers for conducting research in this region, opening up many opportunities for our clients.
Qualia delivers rapid patient recruitment and ensures quick and efficient addressing of regulatory issues. We provide comprehensive logistical support to reduce trial set-up time while minimizing the demands on our clients. Our region-specific experience across the broad range of clinical trial management activities provides clients with successful and timely completion of clinical studies.
Qualia maintains a unique database of investigational sites in Ukraine and Central Europe, where we have developed extensive professional and personal relationships with highly qualified investigational teams experienced in ICH-GCP compliant studies across various therapeutic areas. We ensure the integrity of your clinical trial by selecting investigators experienced in conducting industry-sponsored GCP compliant clinical trials. We provide them with the support of our monitors at each stage of a study. Our local monitors are medical doctors (MD) and Pharmacists experienced in conducting industry-driven clinical trials. With Qualia Europe, our clients benefit from access to a large pool of mostly drug-naive patients, rapid patient enrollment and high level of patient compliance due to centralized healthcare system. Participants are highly motivated and we offer an ideal environment for conducting specialty patient testing. Qualia’s established regulatory interface with the authorities allows expedited review times. The net effect of these factors for the client is both cost-savings and the reduction of time necessary to complete the trial.
We are committed to providing flexible, innovative and focused client service options. Clients can choose to outsource to us only a part of management of the clinical trials: regulatory submissions, logistical support, medical GCP-compliant monitoring, medical writing, data management, or QA/Co-monitoring. Or clients can utilize out proven network of facilities and partnerships to effectively complete nearly every aspect of the clinical research process. Regardless of our clients’ needs, we can provide precisely the service needed. Importantly, we can rapidly join a study at any stage to provide fast patient recruitment when the study falls behind schedule. At Qualia our success is determined by the effectiveness with which we can serve our clients.
Qualia Europe provides access to new clinical trial opportunities that can greatly benefit our clients. Contact us to learn more about how our complete line of client services can work to make your next project a success.
· Consultancy and Project Planning
· Feasibility research and rapid detailed reports
· Strategic planning
· Protocol development
· Investigator and site selection and training
· Investigator meeting organization
· Regulatory Support
· Established regulatory interface with the authorities
· Submission to health care authorities, central and local ethics committees
· Obtaining import and export licenses for investigational product and biologic specimens
· Regulatory consultation
· Obtaining insurance for patients and investigators’ liability for participating in studies
· Medical Monitoring and Project Management
· Clinical trial monitors with basics of all fields of medicine (MDs and pharmacists)
· Local monitors and experienced Project Managers
· Profound knowledge of local scientific and medical communities
· ICG-GCP, SOP and applicable local regulations compliance
· Finance Administration
· Contracting sites/investigators according to the local regulations
· Administration of grant payments to investigators and payments to research centers
· Administration of any other official payments to regulatory bodies, customs authorities & insurance companies
Logistical Support
· Providing specialized customs broker service
· Accountability and distribution of investigational product
· Data Management and IT support
· Development, installation, validation of the database for clinical trials
· Study documents, drug & supplies tracking
· Double data entry procedure to prevent data entry errors
· Data cleaning system including query generation and resolving procedures
· Randomization
· Reporting on clinical trials in accordance with the Sponsor’s and local authorities requirements
· Statistical analysis in accordance with the study protocol
· Programming
· Development of program support for clinical trials
· Development of program support for AE/SAE reporting
· Medical Support for Clinical Trials
· CRF development in accordance with the study protocol
· Organizational Support for Clinical Trials
· Providing clinical sites and the study staff with the special equipment and technical support
· Printing out the CRF hard copies and study documents
· Methodical support for clinical trials
· Trainings and meetings on GCP for investigational staff
· Staffing
· Outsourcing of CRAs, Lead CRAs, Project Managers, Regulatory Officers, Logistics Coordinators, & CTAs
· Country-specific services
· Translations of research materials into local language, independent back translations;
· Legal support
· Organization of long term storing of Study Medication, related materials, lab samples which required special storing conditions and destruction of it in compliance with GMP requirement via Subcontractors
Qualia Europe
Kiev Clinical Operations
office11, 7-a, Shelkovichnaya str
Kiev, 01021, Ukraine
Sergiy Pakharyna MD | Medical Director
Tel: +380442537070
Fax: +380442540044
Email: spakharyna@qualiaclinical.com
Global Business Development
Azhar Kalim | COO
Qualia Clinical Services
Tel: 402.697.6520 |
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