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Study Monitoring
A critical component of any study is the requirement for careful and consistent study monitoring. Our process begins with the selection of study sites who possess the appropriate expertise and experience. Our trained Clinical Research Associates (CRAs) evaluate each potential study site through pre-study site visits and ensure that the study staff and facilities meet all of your study requirements.
Prior to subject enrollment at each center, thorough and complete initiation visits are conducted to ensure that everyone understands his/her role, and detailed documentation is provided in the Initiation Visit Report. Regular telephone communications and site visits are carried out to monitor study compliance and to maintain enthusiasm among study personnel. Detailed Monitoring Reports are provided immediately after each visit. As our client, you can always expect to be fully and promptly updated. With their exposure to our own data management processes and documents, our CRAs develop an enhanced appreciation of the entire query generation process. The CRAs, in turn, will educate and train the sites to ensure that the monitoring is as efficient as possible at each site visit. Thus, our query rate is usually quite low and this savings of time/money is then passed along to the client. All of our activities are conducted according to current regulations and guidelines (Health Canada, U.S. Food and Drug Administration, International Conference on Harmonization Good Clinical Practice (ICH-GCP)). To assure compliance with these regulations, we routinely submit to external/internal audits of our conduct. Unless otherwise specified, we incorporate our Standard Operating Procedures and our strict, in-house guidelines in the management of each study. Our flexibility allows for the utilization of your Standard Operating Procedures in times of true integration - such as when your resources are stretched and temporary monitoring assistance is required for the completion of the study. Committed to the highest standards of quality and integrity, our professional team of associates offers you years of clinical research experience in an ever-expanding number of therapeutic disciplines. From our headquarters in Montreal, or from any of our regional offices, Integrated Research Inc. can satisfy your study requirements at both English- and French-speaking study sites. Client Testimonial: "I would also like to thank you all as I think this [work] is also the result of our coordinated efforts: from our selection of investigators, to the support we provide every day …the clear channels of communication we established, and of course the excellent monitoring done by your well lead team." - October 21, 2006 |
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