Study Execution and Trial Project Management
Project Management
QoL Research has experienced project managers that successfully supervise European Clinical Trials. Our PM in-depth knowledge and risk assessment skills, commitment and experience ensure a smooth conduct of any clinical trial. Assessing real time risks they make sure that the necessary corrective and preventive actions are implemented at the earliest possible stage of a project. Project management also includes optimal selection and supervision of local contractors. Using the principles of strategic leadership, our team provide high expertise throughout a trial in all sub-teams. At the request of our clients we create a dossier that supports the organization, logistics and the conduct of individual processes in a study.
Clinical Monitoring & Administration
Due to demanding training and development programs ensuring high awareness of responsibility and the ability to prioritize tasks, QoL Research monitors take a role of a “communication bridge” between an investigator and a sponsor, supporting research sites. Monitor’s activities are of high quality and efficiency due to strong emphasis on time management skills, effective communication in the remote working environment, auto-coaching and regular knowledge and experience sharing. QoL Research offers various models of monitoring: on-site monitoring, targeted/ remote monitoring and risk-based monitoring depending on client’s needs, degree of difficulty and level of risk in a particular study. Regardless of the type of monitoring, our goal is to ensure compliance with the study protocol, ICH-GCP Guidelines, local regulations and SOPs, ensuring accurate and reliable data and objective assessment of the investigational medicinal product or medical device.
Observational Studies
Our comprehensive experience in conducting non-interventional studies enables us to manage and support the entire process from planning any study to creating the final report. At the request of our clients we create a complete documentation of study (patient Informed consent form, CRF, documentation for patients and documentation related to the management of study), we maintain the relationship with key opinion leaders, perform the oversight of on-going research, as well as provide data management, research reports and the support of publication process.
Medical Device Trials
QoL Research understanding of the regulatory differences regarding the conduct of medical device trials enables our business partners with full service of medical device trial conduct, starting from the protocol writing, through data monitoring, medical monitoring, project management and finally preparation of the final report. We are one of few CROs in the region with such extensive experience in conducting medical device trials which allowed us to build a database of potential research sites, particularly in the area of autoimmune diseases, oncology, diabetes, renal, diagnostics. Compliance of the study with its endpoints and all the requirements and regulations.
Quality Assurance & Oversight
Quality of the clinical trials conducted by our team cannot be compromised. That is why we continuously improve our service. We have prepared audits and oversight visits for our clients which assess monitors’ performance as well as the work of research sites, helping them find new and optimal solutions, if there is a need. Furthermore, we conduct audits of study documentation (TMF and eTMF Audit). Our team serve as a support in preparation of our partners for inspections.
