Quality Management: overview
Our implemented systems assuring the quality of every aspect of the trial are based on quality standards of Good Clinical Practice (ICH/GCP) and sponsors expectations. Within the systems we systematically plan and perform actions to ensure that the trial is performed in compliance with the protocol, GCP and the applicable regulatory requirements.
To provide our stated quality, we start from planning ahead, then implementing the plan and making real-time corrections while settling the issues, responding to queries, analyzing deviations and implementing preventive actions. This system of "planning – doing – reacting – analyzing – acting" is the heart and soul of our quality management.
For better results we offer you our quality management consulting as a full-service engagement (Site Management and Monitoring package), but you can order any of its components, which are described in more details below and in dedicated sections of this site.
Conducting our Smart Feasibility Process (SFP®) we ensure that proper investigational sites are involved in your projects. By planning sites participation in advance, we prepare ourselves for upcoming interaction and also help site staff get themselves better prepared by identifying the sponsor’s expectations more clearly.
Patient recruitment strategies and enrollment facilitation algorithms are in action at the study start-up. It’s important not only to get subjects fast, but also make sure that the patients entering the study fulfill all the inclusion and exclusion criteria and have all evidence of their eligibility properly documented. We conduct such checkup as a part of our Medical Services activities.
Monitoring sites, especially through monitoring visits, is still the most important part of quality assurance. With our monitors strategically positioned, we stay in control of site’s performance and overall commitment fulfillment. By developing symbiotic relationship with the investigators, we are prepared to identify and act promptly on any emerging setbacks. Thinking logically and strategically we try to go beyond conventional working from a checklist.
When your study is in progress full speed, subject retention activities and data management enhancement come into play as part of our Site Management service. We raise share of voice of your study with investigators, facilitate utilization of your web-based study systems, and provide oversight of site’s activities.
To keep the processes flowing fast and smooth we engage our Project management techniques. With the aim of providing consistent study results and clean data, we work on risks mitigation and issues resolution. Our managers take full personal responsibility for communication with sites, CRAs and the Sponsor and are ready to provide rapid response to requests and inquiries. We minimize communication barriers with investigators by utilizing sponsor’s Clinical Trials Management Systems (CTMS) and the benefits presented by integrated data.
To ensure that essential quality assurance procedures are performed we have developed and implemented our SOPs:
- site feasibility SOP;
- monitoring visit SOP;
- distant monitoring SOP;
- electronic documents management SOP;
- regulatory submissions SOP, and others.
Please, feel free to contact us on any business need/task that you have at your hand to get more information on the services we provide and the assistance we can offer to help you move on with your project. We want YOUR project to become OUR successfully accomplished project!