The crucial role of biometrics in scientific research is growing rapidly and exponentially. Data quality along with relevance and appropriateness of statistical analyses are systematically at the heart of regulatory discussions and are essential parameters in the evaluation of medicinal products.
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.
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.
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.
eXYSTAT latest news.
Après la session 2017 à Dakar (Sénégal), eXYSTAT est présent à Antananarive (Madagascar) du 11 au 22 juin pour collaborer avec ...
Emilie vient soutenir l'activité statistique au côté d'aurore CAUMONT et de François MONTESTRUC.
MALAKOFF INFOS. voir l'article, page 13
Nous sommes heureux d'acceuillir Aurore CAUMONT,depuis le début de l'année.
Elle travaillera plus particulièrement en collaboration avec François Montestruc.
eXYSTAT offers the following services in the field of biometrics :
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)
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
Preparation of analyses for committees
Support for interim analyses
Participation in committees and drafting of the report
Selection of experts
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.)
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.)
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 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.)
"Merci à François, Julie. Une rencontre merveilleuse en espérant de nombreux projets ensemble. Bravo à eXYSTAT."Aïda Benalycherif
"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
"Excellente collaboration avec l’équipe eXYSTAT, avec une très grande implication sur les projets DBV, au-delà même de nos attente."Lucas Biela