Clinical Studies (Phase I - IV) Statistical Support Interim, DMC, and final analyses Periodic Safety Updates Data Integration and Integrated Summaries
Consultancy
CDISC Support (SDTM, ADaM, Define-XML) Legacy Data Conversions Trainings and Workshops Data Quality Surveillance
Submission Activities
Preparation of eSubmissions Regulatory Support (FDA, EMA, PMDA) Health Authority Requests
team
We are a team of highly-motivated statistical programmers and biostatisticans. We offer comprehensive expertise in all aspects of our services. We keep up-to-date on regulatory standards.