Ethics/Regulatory

Advanced eTMF systems offer CROs advantages

Sunday, February 15, 2015

It’s no secret competitive pressures are mounting for CROs. Life sciences companies need to get to market faster and more efficiently. Although sponsors are actively investing in CRO partnerships, they want to establish fewer, more strategic partners to improve efficiency. [Read More]

Understanding CDISC adoption

Sunday, February 1, 2015

In the near future, data submitted to the FDA in support of applications for drug approvals must be in CDISC format, as outlined in a draft binding guidance issued in February 2014. If data do not conform, the FDA may “refuse to file” a submission. [Read More]

EMA recommends suspending medicines over flawed studies

Monday, January 26, 2015

A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

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