EXCLUSIVE
CDMO and CRO must become one so clinical research can evolve: Quotient.
‘Merge CDMO and CRO activities to fix the holes in the early phase clinical research industry’, said Quotient Clinical’s CEO Mark Egerton.
Archives for July 4, 2012
New foreign body inspection squad for RSSL
RSSL says its new foreign body inspection team could help get offline factories up and running more quickly following incidents of contamination.
EMA wants debate on clinical data extrapolation; new concept paper
The EMA wants a debate on the extrapolation of clinical data to see if a framework is needed to govern this potential approach to reducing unnecessary research and letting industry use resources more efficiently.
UPDATE
‘Just add water’ for ease of cleaning HP production tech, says Bosch
‘Just add water’ as a preparation for cleaning the stand-in-place tech used to produce HP compounds, says Bosh’s Johannes Rauschnabel.
FDA publishes Celltex Therapeutics inspection 483
The US FDA has published a 483 detailing the violations it observed during an inspection of stem cell firm Celltex Therapeutics in April and the document does not make for comfortable reading.