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ECSOR Expertise at the service of clinical research

Created in 2011, the CRO “ECSOR” supplies its customers with integrated services in the field of clinical research, for medications, vaccines, organic products, cellular therapy and medical devices.

Mrs Isabelle Coupienne, Managing Director & Associate at ECSOR (CRO), Project Manager Vaxxium

© ECSOR

ECSOR is able to take care of all aspects of clinical trials from phases I to IV: this comes in the form of a wide range of services, including medical writing, biostatistics, data management (with the support of an electronic data capture - EDC - platform), pharmacovigilance, clinical monitoring, regulatory aspects (FDA, EMEA) and the writing of clinical reports and publications.

In terms of project management, ECSOR creates and implements the project work plans and revises them in order to respond to changes in needs and requirements. The Project Manager identifies the necessary resources and assigns individual responsibilities. The Clinical Project Manager manages the day-to-day operational aspects of projects and their scope, and also checks the deliverable products prepared by the team before sending them to the customer. The Clinical Research Associate applies its methodology and implements project standards, and ensures that the project documents have been completed correctly, are up to date and archived appropriately. The budget and contracts department follows up and compiles monthly reports on team hours and expenditure but also manages the project budget, determines the appropriate accounting methodology for the products, ensures invoicing is precise and punctual, and monitors debts. The Regulatory Affairs department is responsible for following up legal documentation. Lastly, ECSOR seeks the opinion of the principal opinion leaders in the preclinical and clinical fields.

On top of this, ECSOR is also able to adapt to the requests of its customers and to offer tailored services: a request for statistics, a publication etc.

ECSOR works alongside ResearchLink, a network of GPs that specialises in phase II and III clinical trials and a network of specialist doctors that allows it to promote its expertise in a large number of therapeutic areas: cardiovascular system, alcoholism, diabetes, vaccines (in partnership with VAXXIUM), cancer, cell therapy, pneumology etc.

In future, ECSOR intends to focus its activities on phase I, II and III technical trials to offer high added value to its customers, in partnership with biotechnology companies. But above all it values the very high level of expertise and seniority of its staff: doctors, computer scientists and specialists in biology, pharmacy, pharmacology, clinical biology, biostatistics, medical writing and clinical monitoring. All of them have a tremendous amount of experience when it comes to the pharmaceutical and biopharmaceutical industries, biotechnology, medical devices and CROs. It is thanks to them that ECSOR has 160 national and international studies in a wide range of therapeutic areas. And the turnover of its experts is very low: there is no danger - for ECSOR customers - of seeing 2 or 3 different clinical research managers during the period of their clinical trial! This stability is appreciable… and appreciated.

ECSOR SA/NV Isabelle Coupienne Managing Director & Associate at ECSOR (CRO) Tel.: +32 (0)2 383 04 55 - +32 (0)475 39 27 03 Email: isabelle.coupienne@ecsor.com http://www.ecsor.com

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