1/ Hello Pierre, first, tell me about your entity formerly known as CER? How was it born?
The CER (Clinical Evaluation Report) dedicated service was created in January 2018 based on the observation of the under-representation of this offer in the catalogue of services offered by CaduCeum. Following my previous experience in writing clinical evaluation reports under the MEDDEV 2.7/1 revision 3 guidance, it seemed obvious to me to propose to my Management to reactivate this project under revision 4 of this guidance, so that CaduCeum is able to intervene on the entire development cycle of a Medical Device.
As the requirements of the MEDDEV revision 4 were very demanding, we had to find the right skills and the correct dimensioning for this offer.fter careful considerations and after meeting several different type of profiles for this position, the scientific profiles as PhDs seemed relevant to me. Indeed owing to their specific skill including the ability to develop a strategy to identify the relevant scientific literature, analyze it critically and synthesize it, this profile is the perfect fit for CER writing.
Today, I have a dedicated multidisciplinary team of 8 people in our office based in Lyon, which operates in outsourced project team. The model works under an effective triptych:
Up to now, we have about 20 clients who trust us and appreciate our structured and rigorous approach of work.
2/ We always talk about your entity as being special, a bit apart? What is its difference and how does it fit within CaduCeum?
Yes, it is true! Our entity is completely different from the others!
Foremost, we were the first to operate as an outsourced project team, so the whole team works from our office for our clients. This operation allows us to fully manage projects remotely and to mobilize the various expertise of each consultant on all types of topics.
Then, the profiles recruited for this service are mainly PhDs profiles that were not necessarily the most common within CaduCeum where the demand is rather oriented on general Engineering/Academic profiles and also Pharmacists.
3/ Recently, the CER entity has become CSA.
• What is its meaning?
The name CSA stands for Clinical and Scientific Affairs and covers all CaduCeum lines of business: Medical Devices / In Vitro Diagnostic Medical Devices / Pharmaceutical / Cosmetic.
Taking into account the skills of my team, we became aware of the scope of the types of projects we could lead for our clients. Since the name CER being too focused on «Medical Devices», we started to think about change it in order to fit on all our activities and better reflect this openness to other sectors of activity.
The whole team brainstormed together to find this new name. Since we have determined that the terms “Clinical” and “Scientific” were the most identifiable for all our clients, we choose to include them into our new name: Clinical and Scientific Affairs.
• What are your expectations for this change?
This new name allows us to be more accurate to the diversity of the projects we carry out. In addition to reporting on clinical evaluation/performance reports, we are able to:
-Writing proof of concept; since it is necessary to demonstrate through the literature the existence of an opportunity and/or the feasibility of a system (medical device, medicine, molecule, etc.).
-Write Post Market Clinical Follow-up (PMCF) protocols to collect clinical data for your own product.
-Use scientific literature to validate the medical indication or indication extension of a product already on the market.
-Prepare reimbursement/approval files for competent authority.
-In a general way, to write all kinds of reports based on scientific or clinical literature.
4/ And for you, team CSA (represented in this interview by Morgane, Sonia, Vanessa and Emeline), what this change means for you?
This name change makes sense for us because it better reflects the extent of our skills. Because of our multiple skills, we can intervene in all areas covered by CaduCeum, not just Medical Devices.
We are scientists (PhD in life sciences, Pharmacist-Engineer or Engineer) and are eager for intellectual challenges. Our training, our ability to solve complex problems as well as our critical and scientific mind allow us to easily adapt to different requests from our customers on various issues. Thereupon, each of us contributes to the CSA growth and enriches the team, hence this extension of our range of services.
Thank you for your participation at this interview!