Services
Quality of Life Research small team can be contracted for the day-to-day oversight or performance of operational tasks related to the trial. We conduct 1-4 stage clinical trials with different grades of complexity, including:
All in accordance with the protocol, Standard Operating Procedures (SOP), Good Clinical Practices (GCP) and other applicable regulatory requirements. This activity can be oversighted as required by sponsor.
QoL Research facilitates weekly Study Team Meetings, including setting and circulating agendas, seeking team inputs on upcoming agenda items, taking meeting minutes/notes, drafting and circulating meeting minutes/notes, and identifying/ logging/ ensuring resolution of issues, all operational activities pertaining to the execution of clinical trials. We assist in the creation and review of study protocols, informed consents, case report forms, clinical study reports, study materials and monitoring tools, as requested. We ensure accurate tracking and reporting of study metrics.
Quality of Life Research Team maintains within and with our client, regular internal contact with relevant departments such as Clinical Development, Clinical Science, Clinical Supplies, Regulatory Affairs, Drug Safety and others as necessary. We ensure accuracy and timeliness of vendor and site payments, through invoice review and approval, prepare and track required documentation from clinical sites, review monitoring reports, study invoices (vendor, site), track study progress, provide updates to our Clients Managers, Clinical Operations and maintain study files, update Clinical Trial Management System (CTMS) and ensure completion of systems and tools to enable successful trial execution and reporting. We also can provide training as needed.