PHASE 1 CAPABILITY
For all of our Phase 1 studies, NCGS provides a full range of clinical services, including in-house biostatisticians for pharmacokinetic and pharmacodynamics analyses, medical writing, data management, and a full range of regulatory services. Phase 1 studies require an intimate and collaborative partnership between Sponsor and CRO if data lock is to be achieved both efficiently and with the highest quality data. Success in pivotal studies begins with attention to detail in phase 1, and our tenured CRAs provide the attention our Sponsors demand. With dose escalation studies, constant communication between sites, CRO, and Sponsor is critical to avoid losing precious time and money. NCGS’ approach provides our Sponsors with structured and proven processes that produce quality phase 1 data on time and within budget, every time.
As adaptive trial design moves mainstream, this collaborative approach will become more critical to efficiency and success in the clinic. The foundation for NCGS’ focus on long-term relationships with both Sponsors and sites is often built during phase 1 trials. Due to the collaborative nature of phase 1 trials, Sponsors quickly learn to appreciate NCGS’ way of doing business. NCGS maintains relationships with many experienced phase 1 centers, and these relationships are the catalyst for lower costs, speedy trial results, and greater collaboration.
NCGS places a high priority on conducting phase 1 trials to establish lasting relationships with Sponsors. Our intense focus on collaboration and seasoned processes brings problems to the forefront in time to solve them before they have a negative effect on the overall trial results. Considering NCGS trial managers and lead CRAs often shepherd a compound throughout the development process, we offer only highly tenured leaders that quickly put Sponsors concerns at ease and make NCGS instantly feel like an extension of your own operational team. After all, every success boils down to what motivates the players involved; NCGS makes sure every person involved is focused on the same end goal and has the tools and training they need to reach that goal.