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Nulla vehicula fermentum nulla, a lobortis nisl vestibulum vel. Phasellus eget velit at.
Call us:
1-800-123-4567
Send an email:
monica.wayne@example.com
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
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.
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
Our strength :
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.
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:
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
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.
Year: 2019
Specialty: NUTRITION
Description :
Time to treatment response of a magnesium and sulphate rich natural mineral water in functional constipation
QM intervention:
Randomised phase III interventional study
E-CRF & E-Pro
Design, organisation, monitoring, analysis and publication
Year : 2019
Specialty: SPINAL SURGERY
Description :
Three-year prospective study of surgical outcomes of the IntraSPINE® device in patients treated for degenerative spinal pathologies with lumbar disc disease (submitted for publication)
QM intervention:
Non-interventional study on a medical device
Year: 2016
Specialty: ENT
Description :
Efficacy and safety of chlorhexidine-lidocaine vs. placebo in adult patients with acute pharyngitis
QM intervention:
Randomised international interventional phase III study on a medical device
Year: 2010
Specialty: CARDIOLOGY
Description :
Poster
What differences between resistant and uncontrolled hypertension?
QM intervention:
Transverse study,
case control study
4,090 patients
500 general practitioners
571 cardiologists.
Year: 2014
Specialty : NUTRITION-METABOLISM
Description :
Metagenomics and Integrative Systems Medicine of Cardiometabolic Diseases
QM intervention:
European Project, FP7 2,350 patients
e-CRF with biological samples management and tracking module under controlled temperature
Year: 2018
Specialty : DERMO-COSMETOLOGY
Description :
Efficacy of a repair cream containing Rhealba oat plantlets extract, l-ALA–l-GLU dipeptide, and hyaluronic acid in wound healing following dermatological acts: a meta-analysis of >2000 patients in eight countries corroborated by a dermatopediatric clinical case
QM intervention:
International non-interventional study with multivariate statistical analyses
Year: 2018
Specialty: DERMATOLOGY
Description :
Poster EADV : Post-act interventional dermatology in Europe and Asia : focus on peelings, lasers and surgeries
QM intervention:
International non-interventional study with multivariate statistical analyses
Year: 2013
Specialty: DERMATOLOGY
Description :
A Multicenter, Randomized, Open-Label, Controlled Study Comparing the Efficacy, Safety and Cost-Effectiveness of a Sequential Therapy with RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-Forming Solution with Amorolfine Nail Lacquer Alone in Dermatophytic Onychomycosis
QM intervention:
Randomised international interventional study
Year : 2013
Specialty: INFECTIOUS DISEASES
Description :
Seroprevalence of diseases preventable by vaccination and of 5 other infectious diseases in France
Results of two national surveys, 2008-2010
QM intervention:
Seroprevalence study in a population sample
Year: 2010
Specialty: GYNAECOLOGIE-INFECTIOUS DISEASES
Description :
Treatment of Bacterial Vaginosis: A Multicenter, Double-Blind, Double-Dummy, Randomised Phase III Study Comparing Secnidazole and Metronidazole
QM intervention:
Randomised phase III interventional study run by an expert group
Year: 2013
Specialty: GASTROENTEROLOGIE
Description :
Randomised clinical trial: once- vs. twice-daily prolonged release mesalazine for active ulcerative colitis
QM intervention:
Randomised interventional phase III study
Year: 2010
Specialty: PAEDIATRICS-INFECTIOUS DISEASES
Description :
Incidence of infectious diseases in infants fed follow-on formula containing synbiotics: an observational study
QM intervention :
Non-interventional study
Development of a specific collection and monitoring application
Year : 2010
Specialty : DERMATOLOGY
Description :
Assessment of the effects of a protective cream in the treatment of occupational irritative contact dermatitis of the hands
QM intervention:
Non-interventional study in a professional environment
