Statitec Take control of your clinical data

Statitec

Control your clinical data


Statistical expertise and data management for your clinical studies

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A benchmark player in Life Sciences

A team of experts dedicated to quality

Statitec supports industrial and academic sponsors in the management and analysis of clinical data. Our team combines scientific rigor, regulatory expertise and operational agility to ensure the success of all our customers' projects.

Pharmaceutical laboratories

Biotech

Medtech

Public institutions

A wide range of skills

Our team works on a wide variety of projects, in France and abroad, to meet the specific needs of healthcare players.
Our strength is based on 4 pillars

Regulatory expertise: experience in EMA/FDA submissions, eCTD and CDISC compliance;
Agile organization: secure EDC platform, collaborative project management, SAS and R programming tools;
Quality standard: strict compliance with GCP (ICHGCP), CDISC standards (SDTM, ADaM) and
the RGPD framework;
Integrated quality system: procedures (SOP), internal audits, software validation and commitment to 21 CFR Part 11 compliance.

A mastered value chain

Thanks to its integrated skills, from design to analysis, Statitec offers robust, compliant clinical studies, from data management to biostatistics: design and freezing of the database, cleaning, drafting of the protocol and SAP, programming and validation of Tables/Figures/Listings, regulatory submission.

Data management for clinical reliability

A proactive, collaborative approach

Our processes are based on fluid, continuous communication with all the players involved in the study:

  • Anticipate risks of non-compliance or inconsistent data ;
  • Ongoing exchange between data managers, ARCs and developers to speed up query resolution;
  • Real-time monitoring via dedicated dashboards, offering complete visibility on the progress and quality of the database.

Expertise to transform raw data

The quality of a clinical study depends on the reliability of the data collected. We make data management a central pillar of scientific and regulatory performance.

Database design and validation

Compliant with international standards (CDISC, 21 CFR Part 11), including the creation of eCRFs and the management of secure EDC systems.

Comprehensive data management

From initial configuration to database lock, in compliance with deadlines and regulatory requirements.


quality control


Detection and correction of anomalies, monitoring of requests, coordination with centers, automated cleaning and continuous supervision.

Reliability
and
compliance

Every stage is documented and audited, ensuring total traceability and a level of quality in line with EMA and FDA standards.

High-performance, secure tools

Statitec relies on certified EDC solutions and platforms hosted on secure environments (HDS), in line with requirements. Our systems guarantee traceability (audit trail), reinforced access control and automatic backup.
Our teams apply good data management practices (GCDMP) to ensure process compliance.

Biostatistics from data to decisions

statitec

A solid scientific foundation

A successful study relies on a rigorous statistical plan and an appropriate methodology. Our statisticians work with you right from the design phase to define the optimal design, carry out sample size calculations, choose the appropriate analysis method and write up the SAP. Our aim is to secure your studies right from the design stage, by guaranteeing their scientific and regulatory validity.

Rigorous analysis and interpretation

Our biostatisticians carry out reliable analyses in line with the requirements of health authorities (FDA, EMA, ANSM). Their approach is based on the use of high-performance tools and advanced statistical methods:

  • Linear and non-linear models, analysis of covariance and variance ;
  • Survival analysis (Kaplan-Meier, Cox) and mixed-effects models ;
  • Bayesian methods, multiple imputations and intermediate analyses ;
  • Meta-analysis methods and exploratory post-hoc analyses.

An interpretation to make sense of the figures

A result is only of value if it is understood and used correctly. That's why our teams add value to research data by ensuring..:

  • Automated TLF production via SAS and R ;
  • Interactive dashboards for real-time monitoring of analyses and trends;
  • Support for scientific writing (statistical reports, CSR, publications or presentations).

Methodological advice and support

Statitec also offers an independent statistical consulting service, with :

critical review of protocols, analysis plans or publications
methodological monitoring to optimize the relevance of
statistical approaches and the robustness of results.

The strength of a multidisciplinary group

MultiHealth Group brings together service providers specialized in the clinical development and real-life monitoring of healthcare products at national and international level.

Clinact
Clinical study management
Clinfile
Digital solutions
Statitec
Statistics and data management
TempoPHARMA
Outsourcing and recruitment
FORMATIS
Training Center
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(FR version)

Contact us

contact@multihealthgroup.com

01 80 13 14 70

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