Resourcefulness. Diligence. Attention to detail. Modern Adaptive Approaches.
Project Management is all about keeping your clinical trial on-track and on-time.
Maybe you are aware of CROMSOURCE’s End-to-End Guarantee, assuring sponsors of no CRO-initiated change in scope or change in price. We consistently deliver on this promise through the intelligent execution of our Project Management team.
How can we achieve this?
Project Managers are assigned to a project based on their experience and familiarity with the specific therapeutic area and indication. This prevents costly data errors and provides effective communication between the client, sites, CRAs, and the project team.
CROMSOURCE makes training a priority and all our staff undertake a specific and personalised training program. This means you can rely on the quality of our project management team assigned to your study.
You will find that the CROMSOURCE project teams are characterised by their proactive approach to identifying potential issues and their provision of well-considered solutions. Our teams do not merely create a list of questions to ask our clients! Our organisational structure also allows direct communication with all levels of management and rapid response times meaning our senior management remain in close contact with your project.
The CROMSOURCE project team consider themselves part of your team: together we agree the best solution.
Low staff turnover ensures that Project Team members typically remain constant throughout the duration of a trial.
Adaptive Project Management
Using this approach, CROMSOURCE recognises that plans can be imperfect and uses data collected during the study to make streaming corrections. Adaptive management provides continuous optimisation of day-to-day study practices analysing and solving the operational issues that could negatively impact enrolment, monitoring and query management — producing substantial cost and time savings. Real-time metrics track key enrolment indicators such as reasons for screen failures or effects of individual inclusion/exclusion criteria. Adaptive management applied to the monitoring process, achieved by real-time site metrics, uses a team approach combining continuous site management and remote monitoring with needs-based allocation of site visits. Sites which are performing poorly (i.e. with low enrolment rate, or higher query rates, or more unresolved queries, or slower query resolution) receive greater attention. Moreover best practices from well-performing sites are quickly identified and shared with non-performing sites. Allocating monitoring resources based on the number of remaining unmonitored fields prevents a lagging site from delaying closeout and database lock for the entire study.
Each aspect of the project is managed with our sophisticated and fully customizable Clinical Trial Management System (CTMS), Pioneer. Our systems provide a complete 360° view of the project, supporting accurate and timely decision making by providing critical data in near real-time. The information is available to the client and the CROMSOURCE team and permits all to interact with customizable data on every device via secure web-based access.