The US FDA wants IRBs to remember it is their responsibility to check investigator qualifications, make sure sites are up to code and say if an IND is necessary for the proposed trial.
Outsourcing-pharma.com readers want the acronym CRO to stand for 'contract research organisation' according to the results of a snap poll we ran yesterday.
Outsourcing-pharma.com witnessed a fascinating debate on the definition of ‘CRO’ yesterday with terms like 'collaboration' and 'release' being suggested as potential alternatives.
More analysis suggests that collecting data for non-core endpoints costs individual sponsors millions per clinical trial and the industry billions each year.
UK Government proposals to hand oversight of tissue handling to a non-specialist body would have a negative impact on the preclinical services sector says the Human Tissue Authority.
in-PharmaTechnologist.com presents its weekly round-up of the latest appointments in the pharmaceutical industry, including news from Dendreon, Shire and Targacept.
CMO Synerlab has added lyophilisation and solid dosage form development capabilities to its offering with the acquisition of LyoFal and IDD-Tech Orleans.
A European industry group says EU efforts to ensure the quality of API made by manufactureres outside the region are inadequate and that mandatory inspections of overseas plants are a must.
Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.
An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.
A new personalised medicine-focused partnership for AstraZeneca, expansion in three continents for World Wide clinical and six small CROs team-up to create one super-team. Outsourcing-pharma.com presents a round-up of the latest in clinical research services.
Fujifilm Diosynth Biotechnologies will manufacture the bulk API for ThromboGenics recently US approved eye treatment Jetrea at its facility in Billingham in the UK.
