eXYSTAT is the fruit of constructive and passionate discussions between clinical research professionals.

These exchanges led us to create this company with the ambition of offering expertise in the field of biometrics and clinical development. We take this a step further, proposing features distinguishing us from other biometrics groups currently operating in France.

Our technical expertise is the result of our complementary experience in clinical trials and epidemiological studies. From our backgrounds covering both subsidiaries and headquarters of pharmaceutical companies, as well as in biotechnology companies, our paths have allowed us to develop partnerships with institutional research groups and international Health Authorities.

The complementarity of our skills and professional experience makes eXYSTAT a solid and innovative company, breaking away from the classic mould of providing only conventional biometry services. Our focus on listening to the needs of our customers is reflected in our commitment to develop creative solutions which are both adapted to the study and personalized to the client, while integrating issues related to the global context of clinical studies. Our expertise combined with the strengths of our proposal, positions us as partners and active co-players of your projects.

Associates

François Montestruc
François Montestruc's

expertise lies in methodology, statistics and data-management of clinical trials and epidemiological studies.

François has more than 20 years of experience in the health industry and has managed internal teams as well subcontractors as part of the full biometry services in clinical development. He has managed outsourcing activities of a large number of clinical trials and created departments of biometry and of epidemiological studies in the French subsidiary of a large pharmaceutical company.

Julie Le Boulicaut
Julie Le Boulicaut's

expertise lies in data-management, e-CRFs and databases of clinical trials and epidemiological studies.

Julie has 10 years of clinical experience, beginning her career as a data-manager in the French subsidiary of a large pharmaceutical company, where she managed subcontracted data-management activities or over 2 years.

See Team

News

eXYSTAT latest news.

Session à Antananarive (Madagascar)

Session à Antananarive (Madagascar)

25/06/2018

Après la session 2017 à Dakar (Sénégal), eXYSTAT est présent à Antananarive (Madagascar) du 11 au 22 juin pour collaborer avec ...
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Bienvenue à Emilie BURTE

Bienvenue à Emilie BURTE

05/03/2018

Emilie vient soutenir l'activité statistique au côté d'aurore CAUMONT et de François MONTESTRUC. ...
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Un article dans le magazine de la ville de Malakoff

Un article dans le magazine de la ville de Malakoff

04/02/2018

MALAKOFF INFOS. voir l'article, page 13 ...
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Aurore CAUMONT rejoint eXYSTAT

Aurore CAUMONT rejoint eXYSTAT

08/01/2018

Nous sommes heureux d'acceuillir Aurore CAUMONT,depuis le début de l'année. Elle travaillera plus particulièrement en collaboration avec François Montestruc. ...
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More news

Activities

eXYSTAT offers the following services in the field of biometrics :


Establishment or reorganization of biometrics departments

Establishment of the Department - reorganization or optimization of the Department
Adapted choice of data management and statistics tools based on activities and teams
Assistance in staff recruitment (data entry operators, data managers, statisticians, biometrics director)

Support for biometrics systems quality

Implementation or adaptation of the quality system
Writing or updating, verification, and validation of procedures or manuals
Quality control of databases, analyses and related document programs (manuals, data management report, plan, analysis report, etc.)
Training in procedures
Assistance in the preparation of inspections by Health Authorities
Ensure eCRF, data management and statistics activities are implemented in accordance with applicable regulations

Expertise for the implementation of independent committees (IDMC, DMSB, etc.)

Preparation of analyses for committees
Support for interim analyses
Participation in committees and drafting of the report
Selection of experts
Logistics

Expertise in the implementation of data management activities

Creation or validation of documentation: FIU, completion guidelines, validation plan, data management manual , data management report, etc.
Creation of the electronic CRF, completion guidelines and follow-up of activities
Creation of annotated CRF and database structure
Creation of file metadata CDISC SDTM
Conversion of an existing database into a database format CDISC SDTM
Design and programming of patient profiles, medical listings, etc.
Importation and reconciliation of external data (pharmacovigilance, specific centralized reviews, etc.)

Methodological expertise

Management of scientific technical committees (constitution of the committee, logistics and conduct of meetings, preparation of analyses and presentations to the committee, report writing, etc.)
Methodological expertise for discussions with health authorities (Scientific Advice, IND, NDA, etc.)
Expertise for the drafting and critical review of articles or research reports
Assistance for the publication of the study results (submission of abstracts, congress, oral communications, posters, etc.)

Statistical expertise

Assistance in the development of the protocol or full protocol writing
Calculation of the number of subjects/patients
Statistical Protocol paragraph writing/review
Writing/review of statistical analysis plans
Writing/review of statistical analysis reports
Validation of statistical analyses or exploratory statistical analysis
Contact with expert statisticians or advice on appropriate analysis software

Training for various audiences

Training of statisticians in specific statistical analysis methods or analysis software
Training of non-statisticians for analytical methods
Training in the development of protocols and critical reading of scientific articles
Training of clinical teams, data managers or data entry operators in data management tools
Training for regulatory requirements in the field of biometrics (ICH, 21 CFR part 11, EMA and FDA Guidelines, etc.)

Testimonies

  • "Merci à François, Julie.
    Une rencontre merveilleuse en espérant de nombreux projets ensemble.
    Bravo à eXYSTAT."

    Aïda Benalycherif
    IMEA (Institut de Médecine et d’Epidémiologie Appliquée)
    pour l’ANRS (Agence française de recherches
    sur le VIH/Sida et les hépatites virales)
  • "Vous avez le mérite d’exister. Continuez, ne lâchez rien.
    Le monde de la recherche clinique a besoin de boites telles que la vôtre.
    Longue vie."

    Benoit Piednoir
    Guerbet
  • "Excellente collaboration avec l’équipe eXYSTAT,
    avec une très grande implication sur les projets DBV, au-delà même de nos attente."

    Lucas Biela
    DBV