NVS Consulting Your consultancy partner in clinical research on medicines and medical devices

© Louis Reed © Ousa Chea

Founded in 2008 by Nathalie Van Sante, a physiotherapist trained in medical tests and patient management, NVS Consulting already has over 30 international clients and over 200 contacts in the pharmaceutical and medical device sector.

Marketing authorisation, be it for a treatment or a medical device, is a long journey fraught with pitfalls. NVS Consulting carries out subcontracting assignments for CROs (clinical research organisations) responsible for the management of clinical trials in the pharmaceutical sector, as well as for a dozen manufacturers of medical devices in Silicon Valley and several international pharmaceutical companies. These assignments address the different phases of clinical trials: demonstration of safety and sound cost/benefit ratio, comparison with other existing products, confirmation of the product’s relevance with regard to a placebo effect or another treatment, even the development of other indications, and monitoring for the purpose of determining reimbursement and marketing positioning.

At present, NVS Consulting is actively involved in clinical trials focusing on intensive care (septic shock, cardiac arrest etc.). It also leads oncology trials on behalf of a pharmaceutical company and a project on a new method for the resection of colorectal polyps. In all cases, NVS Consulting is active at all the different stages of the trial, from drafting the protocol to preparing case report forms but also maintains close relations with medical investigators or key opinion leaders in the scientific community, FDA and EMA. Moreover, the launch of any trial is subject to approval by the leading ethics committee, the local ethics committees and by the Belgian's competent authorities (FAG-AFMPS). Once the go-ahead is given, the centres participating in the project need to be trained and subsequently recruit patients who are likely to agree to participate in the project. In addition to these various submissions, NVS Consulting also performs monitoring of the data collected by the investigation centres. At the end of the trial, the centres will be closed and the data can be published.

While the time to market remains long, it varies widely in relation to the molecule or medical device involved. Clinical research entails high costs and the profit recovery time is decreasing in view of the sums invested by the pharmaceutical industry, thereby discouraging longterm research in orphan diseases in particular, because it is not profitable enough. However, the challenge is not only financial, but also administrative. Well-managed clinical research suffers under the weight of procedural requirements that sometimes take precedence over the patient’s interest. NVS Consulting aims to help companies with this administrative approach. Let us hope that the ongoing harmonisation of procedures at European level will make clinical trials more humane, while at the same time continuing to guarantee the protection of the patient, medical quality and scientific relevance. © Drew Hays

NVS Consulting Avenue De L'hippodrome 76 B-1050 Ixelles Tel.: +32 (0)2 479 09 03 E-mail: nathalie.vansant@skynet.be