{"id":830,"date":"2017-08-01T12:13:15","date_gmt":"2017-08-01T12:13:15","guid":{"rendered":"https:\/\/websitedemos.net\/law-free\/?page_id=7"},"modified":"2020-03-20T19:10:28","modified_gmt":"2020-03-20T18:10:28","slug":"home","status":"publish","type":"page","link":"https:\/\/alixpro-pharmaconsulting.com\/","title":{"rendered":"Home"},"content":{"rendered":"\t\t
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AlixPro Pharma Consulting<\/span><\/h1>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Clinical Drug Development & Life Cycle management

Consulting services to biotechs, pharmaceutical industry, CROs and venture capitals<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t+33 6 87 75 46 35\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Catherine Scart Gres, MD<\/b><\/strong><\/h3>
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Experienced pharmaceutical consultant \n \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Medical Affairs and Clinical Development expert\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Skilled R&D manager<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Dedicated and enthusiastic freelance Medical Doctor with more than 25 years of in-depth experience in development and life-cycle management of innovative medicinal products.\u00a0 Providing tailor-made support in a wide range of drug development & medical affairs activities.\u00a0<\/p>

Advising biotechs on the critical decisions relating to clinical development plan, regulatory strategy, clinical operational strategy, competitive positioning and market access – including early access program and post marketing studies.\u00a0<\/p>

Providing medical expertise and strategic input for decisions that have medical, scientific, and future marketing implications.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\tin big pharmas and biotechs\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Practice Areas<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Clinical Development <\/h4>

portfolio\/project evaluation,
development plan management from early stage to MA,
Strategic scientific positionning<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Clinical Operations<\/h4>

protocol design, \nplanning and budget estimation, \nchoosing CROs, \ntrials set up and management,\nmedical monitoring, strong grasp of international guidelines (ICH, GCP)<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Medical writing <\/h4>

design, drafting or review of all clinical documentation (synopsis, protocols, IB, CTA, IND, CSR, CTD, ISS, ISE, clinical expert reports Brieffing packages, publications \u2026)<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Regulatory Strategy<\/h4>

Good knowedge of the regulatory guidances\nInteraction with Agencies
(EMA, FDA, National agencies<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Pharmacovigilance<\/h4>

product safety
medical review
review of safety reports (CIOMs, SUSARs, <\/span>DSURs, PSURs, ISS, ...)<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Market access<\/h4>

early access programs (ATU, compassionate use,..)\npharmacoeconomic studies

Transparency filing\n<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Medical Affairs<\/h4>

shaping product strategy and successfully launching, guaranteeing quality of medical communication in accordance with scientific evidence and commercial strategy,\ndesign of post marketing studies (PASS, Observational PMS)<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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KOLs Management <\/h4>

advisory boards,
DSMB,
sites selection,
symposia<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Business development<\/span><\/h4>

due diligences

licencing opportunities assessment<\/span><\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Professional And Experienced Expert<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Why Choose Alix Pro Pharma Consulting<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Excellent Track Record.<\/h3>

Huge experience in Clinical Research (from Phase I to Phase IV) and in Medical Affairs with severals successfull launches in different therapeutic areas<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Flexibility<\/h3>

Offers a range of services on demand based on share time or full time<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Transparent Fees<\/span><\/h3>

Fees accounted per day or per hour<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

AlixPro Pharma Consulting Clinical Drug Development & Life Cycle management Consulting services to biotechs, pharmaceutical industry, CROs and venture capitals France – Europe – US CONTACT US +33 6 87 75 46 35 Catherine Scart Gres, MD   Experienced pharmaceutical consultant Medical Affairs and Clinical Development expert Skilled R&D manager Dedicated and enthusiastic freelance Medical […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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Development expert Skilled R&D manager Dedicated and enthusiastic freelance Medical\u2026","_links":{"self":[{"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/830","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/comments?post=830"}],"version-history":[{"count":67,"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/830\/revisions"}],"predecessor-version":[{"id":1220,"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/830\/revisions\/1220"}],"wp:attachment":[{"href":"https:\/\/alixpro-pharmaconsulting.com\/index.php\/wp-json\/wp\/v2\/media?parent=830"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}