At URMC Labs, our project management team ensures that your clinical trial runs smoothly, effectively and cost-efficiently. Our faculty and staff bring decades of combined experience in clinical and research laboratory analysis, pharmaceutical industry and global central laboratories.
- Our project managers come from laboratory medicine and research backgrounds. That background, combined with close proximity and regular interaction with analytical and kit production teams, facilitates real-time communication to better serve our clients. The ability to see the big picture yet maintain focus on the finer details provides value to our clients.
- Our project teams have industry experience. Our teams understand the conduct of clinical trials, the central laboratory’s role and the regulatory requirements for a successful study. They will work with your team to proactively define and assess risks and offer mitigation strategies to keep the study on track.
- Our project managers work for you. They are experienced in meeting project timeline and deliverables.
- Create scope of work / laboratory service specifications documents
- Develop study specific forms and operating procedures
- Produce laboratory manual for investigator sites
- Conduct investigator site training
- Monitor investigator site performance
- Communicate study progress with sponsor and/or contract research organization
- Monitor study budget progress for laboratory services utilization
- Our project teams support your investigator sites. The success of your study depends on investigator sites’ ability to recruit and retain subjects. Our project teams collaborate with study sites every day and understand unique operational needs and challenges from a site perspective. This knowledge contributes to the design of site-friendly documents, procedures and communication plans.
- Data Verification and Query Resolution. URMC Labs will initiate query resolution promptly when discrepancies are identified. The project team will communicate with sites as defined by the laboratory services specifications document to resolve discrepancies and to keep data records clean as the project progresses.