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1-800-123-4567

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Know-How & expertise

Clinical research

Our approach applied to clinical research is characterized by a resolutely transversal approach decompartmentalizing the specialties in which we are supported by international KOLs to make the right clinical and methodological choices and to secure safety (DSMB)

From design to publication, our processes which frame and manage your projects are guided by a fair risk assessment, by quality and performance indicators.

The technicality developed by field monitoring (European coverage) is reinforced by changes to our QUANTA View application (proprietary eCRF) and optimized by targeted monitoring (Risk Based Monitoring).

Our experience in clinical research covers a very broad spectrum of pathologies.

Monitoring ensures rigorous supervision of clinical protocol data, in compliance with SOPs, ISO standards and French and European regulatory requirements

Illustration Clinical research
Illustration - Statistiques

Data Management

Our strength: to develop the skills and competences of our teams of data managers to face the growing complexity of clinical research.

Our mastery of the data management process in compliance with international recommendations (EMA, ICH, FDA).

Our guideline: ensure the integrity of the data, their credibility and the reliability of the results to allow your studies to achieve their objectives.

Statistical

Our strength: supporting you in your projects and offering you rigorous and reliable statistical methodologies.

Our ability to design and write protocols, sizing randomized studies, drawing up statistical analysis plans, study reports and peer-reviewed publications

Software development

Our strength :

  • To support you in your projects and offer you proven solutions and tailored to your needs
  • To develop our products in close collaboration with our professional experts (monitors, data-managers, biometricians …).

Our capacity: To develop applications with quality and safety guarantee of the ISO 9001 and 27001 standards and to ensure their hosting, maintenance, support and steady development in compliance with regulatory requirements.

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Locaux Qdata
Illustration Dispositifs médicaux

Medical devices

Our long experience in the very heterogeneous sector of Medical Devices (MD) allows us to consider the best clinical strategies depending on whether it is:

  • active implantable MD, not CE marked,
  • MD marked CE, for a new use,
  • MD incorporating a medicinal substance as an accessory,
  • innovative MD,

Geographical areas of activities

Our clinical research activities deployed throughout Europe allow us to adapt – in the face of numerous regulatory changes – to conduct clinical studies in all countries of the Union European whatever the chosen design

  • Interventional research: RIPH1 or RIPH2
  • Non-interventional research :
    • RIPH3
    • PMS and PMCF
    • European ‘safety’ and efficiency registers
Illustration areas of activity
Illustration géorgie

Georgia

The European territories have been facing difficulties of inclusion for decades (rare and high-cost patients). Our full knowledge of Georgia offers us the opportunity to conduct high quality performance clinical studies (categories 1, 2 & 3 RIPH) to support English-speaking investigating physicians trained in Europe.

Publications

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