AlixPro Pharma Consulting
Clinical Drug Development & Life Cycle management
Consulting services to biotechs, pharmaceutical industry, CROs and venture capitals
+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 Doctor with more than 25 years of in-depth experience in development and life-cycle management of innovative medicinal products. Providing tailor-made support in a wide range of drug development & medical affairs activities.
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.
Providing medical expertise and strategic input for decisions that have medical, scientific, and future marketing implications.
25 Years of experience
in big pharmas and biotechs
Medical expertise
in various fields
Practice Areas
Clinical Development
portfolio/project evaluation,
development plan management from early stage to MA,
Strategic scientific positionning
Clinical Operations
protocol design, planning and budget estimation, choosing CROs, trials set up and management, medical monitoring, strong grasp of international guidelines (ICH, GCP)
Medical writing
design, drafting or review of all clinical documentation (synopsis, protocols, IB, CTA, IND, CSR, CTD, ISS, ISE, clinical expert reports Brieffing packages, publications …)
Regulatory Strategy
Good knowedge of the regulatory guidances
Interaction with Agencies
(EMA, FDA, National agencies
Pharmacovigilance
product safety
medical review
review of safety reports (CIOMs, SUSARs, DSURs, PSURs, ISS, ...)
Market access
early access programs (ATU, compassionate use,..)
pharmacoeconomic studies
Transparency filing
Medical Affairs
shaping product strategy and successfully launching, guaranteeing quality of medical communication in accordance with scientific evidence and commercial strategy, design of post marketing studies (PASS, Observational PMS)
KOLs Management
advisory boards,
DSMB,
sites selection,
symposia
Business development
due diligences
licencing opportunities assessment
Professional And Experienced Expert
Why Choose Alix Pro Pharma Consulting
Excellent Track Record.
Huge experience in Clinical Research (from Phase I to Phase IV) and in Medical Affairs with severals successfull launches in different therapeutic areas
Flexibility
Offers a range of services on demand based on share time or full time
Transparent Fees
Fees accounted per day or per hour