Lab Data Normalization
In a recent development program, the Sponsor was stumped when the central laboratory for the pivotal registration study shut down its services midway through the study. The Sponsor quickly identified another central...
Translational Medicine: Mind the Gap
We are constantly reviewing documents targeting the FDA and EMA. On reviewing a recent pre-IND briefing book for the U.S. FDA, we were struck by some translational gaps in the story board. While these were not significant,...
Our Clientele
We have worked for U.S. and EU-based big pharma & biotech, for small molecules, biologics & cell therapy, across indications.
