Clinical Trial Monitoring
Clinical Trial Services
DocQc ensures that your clinical trials are conducted, recorded and reported according to standard operating procedures (SOPs), Good Clinical Practice (GCP), and other relevant requirements, like ISO 14155:2011. Our team checks the feasibility of your study, makes sure the safety of human subjects, verifies data accuracy and completeness and provides support in solving problems during the entire study period. We’re well-versed in phase I-IV clinical trials. Our team assists investigators and sponsors in identifying a site that is conducive to cost and protocol adherence. DocQc sees to it that the location is equipped with up-to-date, protocol-compliant equipment that facilitates efficiency and data accuracy. We also establish strong communication networks and regulatory documentation processes that enable us to manage the site and mitigate any risks.
Clinical trials mark a costly phase in the development process due to delays and/or interruptions. Let DocQc oversee the conduct of your clinical trial. We will make sure each process is done, recorded and reported in accordance with standard operating procedures (SOPs), Good Clinical Practice (GCP) and other applicable regulations, like those established by Health Canada and the FDA. Our services preserve the scientific integrity of the trial and participant safety; from start-up to close-out.
DocQc strives to promote site performance. Our monitors remain in close communication with data management and site coordinators/investigators to identify and mitigate potential issues.
Our clinical trial/site management services include but are not limited to:
Protocol, ICF and supplementary document review
Study manual development and review
Site selection, qualification and initiation
Assist with ethics committee submission and obtaining approval
Review of quality systems at the site and ensuring all sites are audit ready
Essential documents review, collection and processing
Study specific training of site personnel
Interim monitoring and study closure visits
Source documentation development/review, CRF review and query resolution
Investigational product accountability
Regular communication with site and project teams
Subject/patient safety review
DocQc maintains in-house and regional CRAs to ensure regulatory compliance at all sites. We serve clients in North America and Europe, with monitoring capabilities within Canada and the US.
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DocQc is a clinical trial consultancy that supports clinical research through the provision of trial monitoring, site management & GCP auditing services for both medical device and pharmaceutical studies: pre-market to post-market.