Axelys Santé

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Contact

location_on

9 rue François Coppée
92240 Malakoff
France

public

https://axelys-sante.com/

Dina Mokrani
Business Developer
mail

dina.mokrani@axelys-sante.com

call

+33142534232

About us

Axelys Santé is a CRO offering a full range of services to pharmaceutical companies, biotechs, medtechs and academic institutions.
From clinical development to post-marketing activities, our experts advise and support you at every stage of your project and throughout the life cycle of your healthcare product. 

Business offer

For the management of an overall project, or for a specific assignment involving the development and conduct of interventional (phase I to IV) or observational clinical studies, our services include : 
- Study design: organization of expert panels, consulting and medical drafting of protocols, synopses, methodological and statistical plans.
- Selection of investigator centers: search for investigators, drafting of contracts.
- Regulatory preparation and submissions: to the French regulatory authorities (ANSM, CPP, CNIL).
- Monitoring: on-site or remote control and collection of patient data, set-up and follow-up visits, implementation of data collection tools (eCRF, eQuestionnaires), pharmacovigilance.
- Biostatistics & Data Management: database management, quality control, data analysis and reporting, study report writing.

 

Our offer includes assistance with regulatory procedures:
- For drugs: MA applications and variations
- For medical devices: CE labeling

 

Our experts can also provide support in medical affairs & scientific communication, regulatory affairs, pharmaceuticals & medical information and market access strategies.

Activities

    Categories

    • Service

    Therapeutic applications

    • Cardiology
    • Genetic Diseases
    • Oncology
    • Nervous Central System
    • Hematology
    • Infectiology
    • Immunology
    • Ophthalmology
    • Inflammation
    • Other

    Expertises

    Directory of Antibodies, Recombinant proteins and others
    • Clinical trials
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
    • Regulatory filing
    • Regulatory Filing
    • Post-market surveillance
    • Post-Market Surveillance
    Prophylactic Vaccines Directory
    • Clinical trials
    • Phase I
    • Phase II (human challenge trials)
    • Phase III (large population pending pathogen prevalence)
    • Immune monitoring
    • Data management
    • Regulatory Filing
    • Regulatory Filing
    • New Drug Application (IND)
    • Investigational Medicinal Product (IMPT) for clinical investigations (EMA)
    • Common Technical document (CTD) section 3 (CMC) 4 (NCS) and 5 (Clinics) for submission
    • Post-market surveillance
    • Clinical Trial phase IV
    • Immune monitoring
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