Raising the Bar for Animal Clinical Trials

Jun 28, 2016

Recent advances in veterinary science mean that pharma companies can reap the benefits of health-related quality of life (HRQL) surveys and electronic data capture (EDC) for animal clinical trials, as well as those targeted at the human drug market. In the context of clinical trials, scientific standards demand a degree of consistency, characterised by well-defined measurement using standardised instruments. According to Jacky Reid, BVMS, PhD, DVA, DipECVAA MRCA, MRCVS, founding director and CEO of NewMetrica, as well as providing a more complete picture of the animals’ true experience, this has potentially huge implications for the outcomes, effectiveness and costbenefit profile of trials. ...

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UK Trial Clearance Procedure Realigned with the Rest of the European Union

Jun 28, 2016

The requirements for a UK Animal Test Certificate (ATC or “field trial permit”) were dramatically revised in December 2015, reinstating the UK as an attractive location for veterinary field trials. The UK has long been a recognised location for the conduct of veterinary clinical field trials. Not only is the UK one of the largest Animal Health markets in Europe, the Veterinary Medicines Directorate (VMD) is also a very active and influential regulatory agency in the EU. As Julian Braidwood, Managing Director of Triveritas, illustrates, the new UK ATC application process has been greatly simplified, appears similar to that for many other EU member states, and is now aligned with the VICH Guideline 9 (good clinical practice or GCPv). ...

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