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AIXIAL

AIXIAL is for 10 years an International Service Provider, Contract Research and Safety Organization providing clinical trial and vigilance services to its clients in the pharmaceutical, medical devices, biotechnology, nutritional & cosmetics industries.

AIXIAL is a member of the ALTEN Group www.alten.com the European leader in engineering and technology consulting with 18,000 engineers and scientists. These top engineers and scientists carry out studies and conception projects for the technical and information system divisions of large corporate clients in the industrial, telecommunications and services sectors.

1. TYPE OF INTERVENTION

AIXIAL collaborates closely with its clients to ensure that services are provided in the manner that fits most appropriately with their strategic and operational requirements.

  • End to End clinical Trial Services
  • Functional Service Provider (FSP) Model
  • Business Process Outsourcing (BPO) Model
  • Expert consulting & Advice
  • Resourcing & Staffing

Your full services partner in:

  • Biometry
  • Clinical Operations
  • Vigilance & Medical Information
  • Regulatory Affairs
  • Quality Assurance

2. TECHNICAL EXCELLENCE CENTER

Driven by the success of its core team within the Excellence Center in Clinical Operations, Biometry, Vigilance & Medical information and Quality Assurance departments, AIXIAL is able to rely on experienced and permanent team of clinical and safety professionals to offer efficient and integrated solutions.

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3. OUR OBJECTIVES

Founded in 2004, AIXIAL continues to build on its reputation with a view to expanding its international presence
Having provided services for more than 10 years to the healthcare industry, AIXIAL has developed a thorough expertise in several therapeutic areas, developed an in-depth knowledge of regulations in specific territories as well as the latest and best practices:

  • Well-established experience in most of therapeutical fields especially in CNS, Cardio-Vascular diseases and Oncology, Orphan Drugs, Medical Devices and Combination Products.
  • Strong know-how and offices in Western and Central Europe.
  • Global Safety and Risk Management approach: integrated, proactive and science-based.

4. KEY FIGURES

Since its foundation in 2004, AIXIAL has recorded double-digit growth in turnover year on year. It has also seen a significant increase in team numbers in all areas of activity.

Contact

  • AIXIAL FRANCE

    4 rue Danjou – Bâtiment B
    92513 Boulogne-Billancourt Cedex

    T : +33 (0) 1 46 0 88 900

  • AIXIAL BELGIUM

    Chaussée de Charleroi 112
    1060 Brussels

    T : +32 (0) 2 774 88 11

  • S.R.O. (APROVA)

    Jana Uhra 10
    602 00 Brno Czech Republic

    T : +420 (0) 532 195 996

Contact us

  • Biometry

    Highly-skilled team dedicated to your projects assuring you on fast and quality work. Our most experienced Data Managers, Programmers and Biostatisticians are coming from the Big Pharmaceutical Companies. AIXIAL Biometry [...]

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  • Clinical operations & development

    AIXIAL offers pharmaceutical, biotech and medtech companies full coverage of Phase I-III and late phase clinical studies for drugs and medical devices in Western, Central and Eastern Europe through our [...]

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  • Vigilance & medical information

    AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product safety in Phase I to IV and, post-marketing clinical studies across a broad [...]

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  • Regulatory affairs

    Preparation and submission of tender files to the relevant authorities Management of registration files: • Drafting of marketing authorization applications (all modules) in centralized, decentralized and mutual recognition procedures • [...]

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Expertise

  • BIOMETRY

    Highly-skilled team dedicated to your projects assuring you on fast and quality work. Our most experienced Data Managers, Programmers and...

  • CLINICAL OPERATIONS & DEVELOPMENT

    AIXIAL offers pharmaceutical, biotech and medtech companies full coverage of Phase I-III and late phase clinical studies for drugs and...

  • VIGILANCE & MEDICAL INFORMATION

    AIXIAL offers pharmaceutical, biotechnology, medical device, nutritional and cosmetics companies full coverage for post-marketing vigilance and product...

  • REGULATORY AFFAIRS

    Preparation and submission of tender files to the relevant authorities Management of registration files: Drafting of marketing authorization applications...

  • QUALITY ASSURANCE

    Audits (investigator sites , CROs, PV System audit) Quality control of documents submitted to relevant authorities Drafting and revision of...

AIXIAL offers different service levels to provide the best response to clients’ needs.