STATITEC
Take control of your clinical data
A leading player in Life Sciences
Data management for clinical reliability
- Anticipation of risks of non-compliance or data inconsistency;
- Ongoing communication between data managers, ARC, and sponsors to speed up the resolution of queries;
- Real-time monitoring via dedicated dashboards, providing complete visibility on the progress and quality of the database.
Design and validation
of databases
Compliant with international standards (CDISC, 21 CFR Part 11), including eCRF creation and secure EDC system management.
Complete
data management
From initial configuration to database lock, in compliance with deadlines and regulatory requirements.
Quality
control
Detection and correction of anomalies, request tracking, coordination with centers, automated cleaning, and continuous supervision.
Reliability
and
compliance
Each step is documented and audited, ensuring full traceability and a level of quality that complies with EMA and FDA standards.
Biostatistics of data for decision-making
- Linear and nonlinear models, covariance and variance analysis;
- Survival analysis (Kaplan-Meier, Cox) and mixed effects models;
- Bayesian methods, multiple imputations, and interim analyses;
- Meta-analysis methods and exploratory post-hoc analyses.
- Automated production of TLFs via SAS and R;
- Design of interactive dashboards for real-time monitoring of analyses and trends;
- Support for scientific writing (statistical reports, CSRs, publications, or presentations).
