The FDA has issued draft guidance detailing the information that should be submitted to an IRB as part of the continuing review of a clinical trial, with particular emphasis placed on the rise of multi-site studies.
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
Outsourcing-pharma presents a round up of all the latest deals and developments in the contract research space. This week Synexus closes ClinPharm deal, GVK joins ResearchPoint Global and CliniPace wins gNO contract.
Continuing production of medically necessary products (MNPs) in the event of a pandemic will be made easier by developing a contingency plan, according to the FDA which has issued guidance on the subject.