We are excited to announce that Xcellerate® Medical Review has been named a finalist in the Clinical & Research Excellence (CARE) Awards. As a finalist in the Best Sponsor-Focused Technological Development category, Xcellerate Medical Review is being recognized for its modern approach to improving the clinical trial process. The CARE Awards …
Preclinical Success to Clinical Failure: Do We Have a Model Problem or an Endpoint Problem?
As the AACR (American Association for Cancer Research) Annual Meeting is fast approaching, many industry and academic scientists are busy preparing talks and posters for what they hope will be the next new wave in cancer therapy or the next “new and improved” preclinical model. However, while these may be …
Phase I cGMP Drug Manufacture at the CRU: 3 BIG Benefits
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 …
The Biosimilars Landscape: What All Developers Need to Know
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …