Ingenious | Diligence | Attention to detail | Adaptive Approaches
Project Management is all about keeping your clinical trial on-track and on-time.
PRORELIX RESEARCH delivers.
Maybe you are aware of PRORELIX research’s End to End Guarentee, 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.
PRORELIX RESEARCH makes training a priority and all our staff undertakes 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 PRORELIX RESEARCH project teams are characterized 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 remains in close contact with your project.
The PRORELIX RESEARCH project team consider themselves part of your team: together we agree the best solution.
Adaptive Project Management
Using this approach, PRORELIX RESEARCH 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 sophisticated and fully customizable Clinical Trial Management System (CTMS). 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 PRORELIX research team and permits all to interact with customizable data on every device via secure web-based access.
ProRelix Research has successfully managed complex projects in multiple therapeutic areas and are proud to have supported small to medium size companies. In addition, our specialized expertise in working with emerging pharma, biotech, and device companies helps us guide them through the clinical development process.
Our Project Managers collaborate with you from the start to ensure every aspect of a project is planned for and executed precisely. Our project management methodology incorporates standardized processes and metrics for reviewing project progression, risk assessment-mitigation, and completion. Our goal is to complete every project on time and on budget while maintaining the high-quality product for which we are known.
Our project management team handles all requirements
Our full-service capabilities allow us to handle an entire program or the services specifically needed by our clients, from protocol strategy to regulatory submission and post-marketing. Our project management responsibilities include:
- Primary Liaison with Clients
- Team Management (Internal and External)
- Timeline Management
- Budget Management
- Project Status Reporting
- Risk Mitigation/Management
- Vendor Management
What we say is what we do
Perhaps our most important differentiator of all, we deliver what we promise. We are accessible – any time, any level, anyone. We offer you direct access to our executive, senior management, and project teams. Transparency in projects is a critical component of our partnership.