Successful ataxia research inspection
31 October 2012
Congratulations to Dr Paola Giunti who successfully led her research team through an MHRA inspection last month.
Dr Giunti’s team, including Dr Michael Parkinson and Mr Arron Cook, is based at the Specialist Ataxia Centre at the National Hospital for Neurology and Neurosurgery.
In her summing up, at the end of the 2 day site inspection, the MHRA inspector declared that there were no critical or major findings – only some ‘other’ findings. A final report is awaited once the sponsor company has fed back requested information to the MHRA following their one day inspection.
This excellent outcome is not easy to achieve. The team should be congratulated for running clinical trials to the standard expected by the MHRA inspectors.
Dr Giunti said: “I am very pleased with the inspection outcome,
“This firmly confirms the Ataxia Centre is a qualified centre for future clinical trials in these rare conditions. I think the success lies in a very strong team spirit with good communications among us and with the sponsor”.
Dr Giunti is Principal Clinical Research Associate and Honorary Consultant at UCL/UCLH and has been the Chief Investigator for the European multicentre study ‘A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)’.
A special thank you goes to Nathalie Passeron for her performance at the Pharmacy inspection interview session.
To read more about ataxia: www.ataxia.org.uk/pages/ataxia-centres.html