Régis Sainz Email & Phone Number

France

Desio, Lombardie, Italie

Région De Marseille, France

Région De Marseille, France

Early Clinical Development.

Home Based From Marseille

Neurology (Lower Limb Spasticity) 10 countries involved – Phase III• CRAs & new Lead CRAs coordination, communication & support : issues resolution / reports reviewing / mentoring / timelines management for handover, recruitment, data base lock and close out visits (> 30 people managed in total and 15 simultaneously).• Responsible of project-related and ICH GCP trainings for CRAs (preparation, presentation).• Site Assessment Visits across Europe (>40 visits on sites) and follow up of Corrective Action Plans.• Conception of Key study documents : Global Monitoring Plan, Annotated visit reports.

Home Based From Marseille

Employed by Chiltern until December 2011, then directly employed by Allergan.Urology (Urinary Incontinence) 3 countries involved – Phase IIaUrology (Urinary Incontinence) 15 countries involved – Phase III• Preparation of Data Base Lock (participation in Data Manual Review)• Management of 8 sites in France & Belgium

Marly Le Roi (78)

Oncology (Melanoma) 4 countries involved – Phase IIOncology (Melanoma with Brain Metastasis) 4 countries involved – Phase IIOncology (Renal Cancer) 25 countries involved – Phase III• Development of working documents (ICF, patients card, triptych)• Third party management (translators, central labs, IMP manager, printers, data manager)• Investigator meeting organization & lead• Budget Management (Provisions, Global invoicing & Budget management including negotiation).• Authorities (CPP & AFSSaPS) submissions

Le Plessis Robinson (92)

countries involved - Phase IIIOncology (T-Cell Lymphoma) 3 countries involved - Phase IIEndocrinology (Diabetis) In France - Phase IIIHepatology (Fulminent Hepatitis) In France - Phase IISummary of duties: Site Identification Development of working documentsThird party managementProject team management & trainingSponsor communicationMonthly report writingCRF makingInvoicing & Budget managementAuthorities (CPP & AFSSaPS + TGA) submissionsNewsletter writingReports reviewing

Le Plessis Robinson (92)

Oncology (Colorectal Cancer) Monitoring (8 sites) – Closure (19 sites) – Phase IIIVirology (AIDS) Monitoring & Closure (7 sites) – Phase IIIbSepsis (ICU) Pre study visits (6 sites in Bel & 7 sites in Fr) - IIIOncology (AML, CML & MDS) Initiation, Monitoring & Closure (3 sites) – Phase IPaliative Care Unit (Pain) Feasibility – Phase II Oncology (B-Cell Lymphoma) Pre study, Initiation & Monitoring (4 sites) – Phase IIINephrology (Renal Failure Monitoring (4 sites) – Phase II)Trial Feasibility / Collection of essential documents / Pre study visits (conduct & preparation) / Initiation visits (conduct & preparation) / Monitoring visit (conduct & preparation) / Close out visit (conduct & preparation)

Gentilly (94)

Oncology (Cancer of the prostate) international Phase III, opened label, at the hospital.Neurology (Multiple sclerosis) national, longitudinal, opened label.Neurology (bipolar Confusions) national Phase IV, opened, at the hospital.Medicine vascular (Thrombosis) international Phase IV, double blind vs. placebo, at the hospitalNeurology (Chorea of Huntington) national phase II study, double blind vs. placebo.Summary of duties:Initiation: Active participation in study presentation - Realization of a computer tool allowing to foresee the inclusion of the patients - Aid in elaboration of study documents - Organization of administrative documents.Monitoring: Review of the CRF - Update of the files - Check of the data sources and accounting treatment accountability - Investigator study file update - Management of queries - monitoring report - Boost investigatorsClosure: Organization of the filing and the review of the pharmacist and investigator files.

Master 2, Management De La Santé

Activities and Societies: Diploma of supplementary specialized studies: Master 2 - Health problem & health management - Speciality.

Maitrise, Neurosciences

Licence, Biologie Cellulaire Et Physiologie

Deug, Sciences De La Vie