Using a cGMP pharmacy at your CRU for Phase I drug manufacturing yields benefits in quality and safety, timeline reduction and cost efficiency.
The regulatory environment continues to move toward requiring drug manufacturing at current good manufacturing practice (cGMP)-compliant pharmacies. This trend and other factors make it increasingly attractive to use cGMP compounding on-site at your CRU for early development. Let’s look at Three Big Benefits for Phase I drug manufacturing:
- Quality and safety
- Timeline reduction
- Cost efficiency
Introducing a drug into the human body for the first time is an important milestone. Considerable investment goes into preparing for this day, with more to follow — 70% of the R&D cost needed to bring a drug to market is spent after Phase I. With so much at stake, human safety and early efficacy are now driving more go/no-go decisions than ever before.
Early Clinical Research Centers
With clinic locations throughout the US and Europe, we recruit a diverse healthy and patient population to participate in your clinical study. You have access to over 350 beds for fast and flexible study startup and a dedicated team of recruiting specialists for success in filling panels. In addition to the stability and reputation for quality that underscores all clinic operations, each clinical research unit offers you specialized capabilities such as a glucose clamp unit in Dallas, a human appetite lab in Leeds, and a dedicated cGMP pharmacy support team for radiolabeled AME studies in Madison. A clinical site will be selected based on your study needs and preferences, site experience conducting similar studies and site capacity. For more information about the clinics, please visit our website. Continue reading