Now in its 6th year, the Christine Pierre Clinical Trials Lifetime Achievement Award, in association with mdgroup, celebrates the ground-breaking work and contributions of individuals across the field of clinical trials who are making a positive difference. The shortlist for the 2020 prize has been announced and we are taking a closer look at each of the nominees - see all the profiles here. Here we focus on Danielle Giroud, CEO at MD-CLINICALS, Switzerland. Cast your vote here to have your say on this years winner.
Why she was nominated
"Danielle Giroud chaired ISO/TC 194/WG4 "Clinical investigations in humans" for more than 10 years and was the key player in creating the revision of ISO 14155: 2011. She has managed to get the various regions and regulatory authorities around the table to create a globally recognized document.
The new version of ISO 14155, published in July 2020, is a significant improvement on the 2011 version. The extensive additional clarification and guidance will be very useful in facilitating best practice in an area of critical concern to the development of new medical products and the safety of patients, whether involved in clinical investigations or benefiting from the use of devices that have been clinically tested. The publication of the third edition of ISO 14155 will lead to a more thorough and consistent adoption of GCP principles and support good study design to provide solid clinical evidence and brings the following new features:
- The application of a risk-based approach/risk management in all aspects of clinical investigations with medical devices.
- Streamlined statistical concepts for good study design
- Guidance on level of applicability to post market clinical investigations
- Guidance for ethics committees
- Guidance on auditing/inspections of clinical investigations
- Alignments with latest regulatory requirements”
How the voting works
Voting is now open until 9 October 2020, 12pm GMT. We will impartially encourage our online community to vote; each finalist is also encouraged to reach out to their colleagues and contacts. Anyone in the online clinical trials community can vote, but only once each. Both voting and the opinion of the expert panel will be taken into account when choosing the winner. The prize will be presented at the Clinical Trials Europe virtual event on 4 November. Cast your vote for this year's Lifetime Achievement Award winner here.