Cecile Rousseau
EmailVCLS – Voisin Consulting Life Sciences
Voisin Consulting Life Sciences (VCLS) provides end-to-end HealthTech solutions, to support biotechnology, pharmaceutical and Medical Devices manufacturers throughout their product development and life cycle.
VCLS is the global reference partner to expedite access of HealthTech products to regulated markets. VCLS is a team of 300 professionals, committed to delivering innovative solutions in life sciences to patients and the HealthTech professionals. VCLS believes that product development must be driven by a solid understanding of the environment where the product will be launched and the criteria to be assessed by both regulators and payers.
From discovery to patients, VCLS offers integrated solutions including but not limited to development planning, regulatory strategy, manufacturing, quality and control, nonclinical and clinical testing, clinical trial operations, registration and commercialization, post-launch, and vigilances.
With a presence in 10 countries:
- Paris and Rennes, France,
- Cambridge, MA and Somerville, NJ, USA,
- Cambridge and Camberley, UK,
- Lausanne, Switzerland,
- Copenhagen, Denmark,
- Helsinki, Finland,
- Stockholm, Sweden,
- Bangalore, India,
- Shanghai, China,
- Antananarivo, Madagascar.
Role in Metastra
VCLS is bringing to the consortium years of expertise in HealthTech product development including but not limited to integrated approach, regulatory strategy, as well as know-how in software as medical device (SaMD), clinical decision support tools (CDS) and management of clinical trials.
VCLS is in charge of developing the METASTRA regulatory strategic roadmap towards CE marking of the proposed SaMD/CDS. To do so, VCLS is leading Work Package 6 (WP6) related to Quality, Technical and Software documentation to support CE marking efforts. VCLS is also acting as Clinical Research Organization (CRO) to conduct and monitor both retrospective and prospective clinical studies (TRAIN-METASTRA = WP2 and VALIDATE-METASTRA = WP5, respectively). VCLS is therefore reviewing core documents that the hospital partners of METASTRA consortium are required to submit to the competent authorities in order to conduct these clinical studies. VCLS is also authoring additional documents necessary to run the clinical trials (e.g., Monitoring and Project Management Logs and plans) and perform the monitoring activities (e.g., Site Initiation Visits, Monitoring Visits, Close-Out Visits). VCLS is contributing as well to the other WPs by bringing regulatory and quality expertise in the deliverables.
