Flagship services
Our core expertise
Four areas of excellence where our expertise makes the difference.
Clinical Data Management
Quality management of your clinical data throughout the study, from database design to data lock.
- Clinical database design and validation
- Data cleaning and query resolution
- Database lock and archiving
CDISC (SDTM, ADaM)
Conversion and standardization of your clinical data according to CDISC standards for regulatory submission.
- SDTM mapping and conversion
- ADaM dataset programming
- define.xml and reviewer's guide generation
Statistical Analysis
Design and execution of your clinical statistical analyses, from SAP to final outputs.
- Statistical Analysis Plan (SAP) writing and review
- Tables, listings and figures (TLF) programming
- Exploratory and confirmatory analyses
Medical Writing
Writing and review of clinical and regulatory documents, compliant with ICH guidelines.
- From draft to report: CSR and protocols end-to-end
- CRFs designed for quality and traceability
- Sample size and randomization tailored to your objectives
Additional services
Further expertise
Medical Coding
MedDRA, WHODrug — rigorous coding and quality control per international standards.
Remote Data Review
Remote clinical data review and quality control in real time.
Project Management
End-to-end management of your clinical and data projects, on time and within budget.
Training
Tailored programs: data management, biostatistics, CDISC and AI tools.