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Developed as a fully integrated academically based service organization, the CHRC supports the range of industry needs from phase II clinical trial development and coordination to the execution of large scale investigator meetings. By being full service costs are managed effectively and projects are completed within budget. The CHRC utilizes a “turn-key” scope and budget approach that a priori precludes budget over runs. Now in its twelfth year of business, the CHRC has a stable and matured platform for the conduct of all clinical programs. The organization operates with two major functional divisions: clinical operations and logistics operations. These divisions draw on an experienced team of staff working with the latest technological and programming resources. Clinical operations is lead by the medical team comprised of key physician opinion leaders who regularly serve as principal investigators in major clinical trials and preside on medical advisory boards for major pharmaceutical organizations. The CHRC’s logistics operations are lead by an experienced team who ensure all aspects of site management and administration and physician initiation are managed with minimal to no time delays. From contract negation with customers to the execution of site agreements, from planning and executing investigator meetings to completing site initiations, the CHRC can reduce the start-up cycle time for a clinical trial to a fraction of that experienced with typical CROs. All site contract development, site grant administration and associated sponsor funding reconciliation is managed in-house. Over the past ten years the CHRC has not only developed exceptional relationships with the medical departments of major teaching and community hospitals, but has also developed significant lines of communication with the legal council and research administrative offices representing clinical researchers across Canada and the United States. The CHRC’s capacity for rapid execution of clinical agreements is unmatched. To compliment its research strengths, the CHRC has in-house event coordination capabilities that closely integrate investigator meetings with the site selection and initiation process. Regional and local meetings are managed to ensure the benefits of economy of scale planning and minimize third party flow through costs. Utilizing networks of preferred vendors and suppliers, the CHRC can deliver a 5 star performance well under anticipated budget targets. An important bridge between site selection/invitation/initiation, project management and completion of on-time patient enrollment is data management and site monitoring. The CHRC has a developed a data coordination centre and monitoring group capable of supporting paper-based and electronic data capture. Clinical and monitoring staff are certified members of the Society of Clinical Research Associates (“SoCRA”) and our Standard Operating Procedures (SOPs) meet all regulatory and industry standards.
Business Unit Overview The CHRC is organized into several specialized and thematically organized business units each with dedicated technologies tailored to their specific research and teaching activities. The CHRC Business Units are:
In direct support of these activities, the CHRC has built an organization with proven expertise in cardiovascular medicine, bio-statistics, health sciences, project management, internet technology, graphics design, database development and programming, hospital/grant administration and marketing. This multi-disciplinary approach has resulted in the development of a comprehensive process for the design and management of clinical trials, observational studies, registries and continuing medical education. In addition, the CHRC promotes and supports continuing education amongst its employees ensuring credentialing that is ahead of industry standards.
Medical Education The CHRC delivers integrated CME programs that partner with pharmaceutical companies to deliver measurable results through clinical research initiatives and continuing medical education across the cardiovascular continuum. With a strong academic background and through our participation as a leader in clinical trial development and the publication of peer-reviewed articles, our educational programs provide relevant, evidence based and recent information for the professional development of physicians and facilitate compliance with established treatment guidelines. Our mandate is to integrate medical education, speaker training, clinical research, meeting and travel services, and interactive media into one succinct package. We stand apart by providing our clients with innovative strategic and tactical solutions without losing focus of current guidelines and treatment gaps. Through our education initiatives, we have been successful in influencing change in physicians’ practice. We have an exclusive expertise in cardiovascular and metabolic health, strong and well developed relationships with local and international key opinion leaders, medical marketing solutions through clinical research and strategic integration of live, print, electronic, web and clinical programming. Key areas of expertise:
Logistically, CHRC can manage the invitation of targeted delegates, the selection of venues, vendor negotiation, all aspects of the on-site logistical support for the successful completion of these meetings and financial reconciliation with sponsors. We are dedicated to providing the highest quality of service to our clients. Our personal touch and attention to details are the cornerstones of our success. Supporting pharmaceutical companies developing new drugs therapies and producing clean, scientific data, ready for statistical analysis and compliant with regulatory guidelines is the fundamental basis upon which the data coordination centre (DCC) team performs. The CHRC has developed innovative approaches for solid data management execution which include:
The CHRC’s approach is to ensure that very early in the process a team is selected to initiate CRF development and the data registry for the study CRFs with a critical eye to the primary and secondary objectives of the study. Standard Operating Procedure development is completed by applying in-house SOPs and Sponsor specific requirements with the aim of producing a front end that will minimize redundant, ambiguous, incorrect data collection and entry. This early in-house evaluation of database structure by medical, statistical and programming staff is the first critical step in database management. A “soup-to-nuts” approach to ongoing review of raw data ensures discretion in database entry and leads to early and proactive query resolution through feedback to monitors and sites. The DCC team achieves global consistency and quality through centralized design and control of the data entry process. The most salient recognition of the CHRC success in data management is the repeated requests to participate in “rescue” operations with very short deadlines to meet Sponsors critical milestones. Close affiliation with academic resources at American and Canadian teaching and community hospitals and universities assure a comprehensive and accurate review of resultant statistical summaries of clinical databases evaluations of outcome analyses and quality of life measures. Finally, the need to investigate other important and clinically relevant questions can be facilitated through pharmacoeconomic evaluation and determinations of cost of clinical practice with patient quality of life measures.
The Holter/ECG Core Laboratory is staffed by a carefully trained and experienced group of independent readers. This group has unique experience in ambulatory ST segment monitoring and is overseen via regular round table review by Canadian Heart Research Centre Medical and DCC staff. The Holter/ECG Core Laboratory has demonstrated its high quality of services in a number of large clinical studies analyzing ECGs and >5,000 Holter monitor recordings since it's inception. In addition to acting as the reference centre for clinical interpretation, the Holter/ECG Core Laboratory coordinates receipt and return of tapes, CRFs and CDs between sites, Sponsor and the Core Laboratory. Central Biochemistry/Blood Laboratory
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