Hubert LESUR

ACRP Certified Clinical Research Coordinator

Auditor

Founder HL Health Support 

Background

After a succesful career start in Clinical Research being Head of patients and volunteers recruitment and relationships for Phase II/III clinical trials in cosmetic and dermatology for 4 years, he then contributed to the creation and development of the first french service provider specialized in healthcare information readability for patients and investigators assistance in clinical resaerch, for 10 years (ITWELL SAS).

His notable achievements were :

 

• development of a dedicated service focused on Investigators assistance in clinical trials performance, including detachment of Study Cordinators on site and one of the first network of ambulatory Research Nurses for intervention at patients home,
• creation and developement of a dedicated service of evaluation and improvement of Patients Information Leaflets by and for users, according to EU Directive 2001-83-CE,
• the implementation of a Quality Management System in accordance of ISO 9001:2008 requirements including the first process designed for PIL readability user tests,
• standing as Expert in healthcare information for patients and representing France at the Quality Review of Documents (QRD) at the EMA (European Medicines Agency)
• performance of internal audits, second party audits (providers) and third party audits for Quality Management Systems conformity (ISO 9001:2008), pharmacovigilancy systems and ICH-GCP conformance audits for pharmaceutical companies and hospitals.

 

HL Health Support

 

The creation of HL Health Support in 2016 coupled with an audit training is a return to fundamentals of operationnal assistance in clinical research, including services such as:

• dedicated asistance to Investigators for clinical trials performance
• FDA or EMA regulatory Inspection readiness for clinical research sites or pharmaceutical companies
• performance of internal audits, sedonc party or third party audits tailored upon the auditee needs (hospital departments, pharmaceutical companies, healthcare providers and vendors in clinical research, for Quality assessment including the latest ISO 9001:2015, targetted on ICH-GCP requirements or combined.