Project Management in Clinical Trials

An EFPIA Perspective

Frederic Peyrane is one of COMBACTE’s EFPIA partners from Da Volterra. He is the Lead Project Management Officer in COMBACTE-NET.

“The role of the Project Management Office (PMO) is to support the Management Board in its decision-making process, and, as such, the PMO manages the administrative, financial and scientific coordination of the program and the communication activities. As PMO Lead, my main concern is to make sure that the right information is made available with the right level of complexity in order to inform the decisions of the Management Board. It is a delicate exercise especially in such a large program, involving more than 40 partners. It honestly took me some time when I arrived a year ago, to understand all the links and to learn the full history of the now 8-year old project. But thanks to the active members of the PMO team, we managed to get two amendments approved in less than 9 months, and now the project is in good shape for the final rush until October 2023”.

Common goals

Lisa Grimsditch leads the COMBACTE-CARE Project Management Office since 2016. She is part of Pfizer, the lead EFPIA partner in the COMBACTE-CARE project.

“One of the major advantages of working in a public private partnership, from my perspective is the opportunity to work with partners from many different institutions and establish a set of common goals that we all work on together to support. This ensures that we can all work through the challenges and find a way forward in order to deliver requirements to time, quality and budget”.

Win-win

Academic partner Julie Vignaud-Benamirouche from CHU Limoges is one of the Project Managers in COMBACTE’s SAATELLITE and EVADE studies. She is very enthusiastic about the collaboration with the EFPIA partners in the studies, stating there is a great exchange of knowledge and most importantly, a feeling of trust between the partners.

“In the SAATELLITE and EVADE studies, where we worked together with AstraZeneca/MedImmune, we have been able to create a strong relationship of trust, beyond the partnership. There is a real sharing of skills, in a ‘win-win’ fashion. And it is a complementary and constructive collaboration. They have the financial and global skills and stature, we have the ‘real life’ clinical expertise from the field.

We must be a link, all the time for everyone, and that can be a challenge: coordinate the academic partners, keep the relationship with the EFPIA partner, and above all maintain a smooth collaboration with the sites”.

“The pandemic has had a very big impact on our daily lives, especially in clinical departments. Although this situation has forced us to cancel our major COMBACTE face-to-face events in like the General Assembly for a year, Zoom/Teams/Webex meetings have allowed us to stay in touch, and maybe even see each other more than before. There is always a way”.