EARLY - PHASE CLINICAL RESEARCH

Data Management &

Statistical Services

A developed & experienced unit for quality Data Management and Biostatistical analysis.

CRS provides integrated Data Management and Statistical services designed to ensure high-quality clinical data, regulatory compliance, and reliable study outcomes. All data activities are supported by our dedicated, validated electronic data capture (EDC) system, hosted on CRS-managed servers, providing full control over data security, access, and system performance.Our data management team oversees the complete data lifecycle, from database design and setup through data cleaning, validation, and database lock. We develop study-specific eCRFs, data management plans, and edit checks aligned with protocol requirements and regulatory expectations. Rigorous quality control processes ensure data accuracy, consistency, and traceability throughout study conduct.CRS supports real-time data review through integrated workflows with clinical operations, pharmacovigilance, and project management. This enables timely query resolution, ongoing data oversight, and early identification of data trends or issues that may impact study execution or analysis.Our statistical services cover study design support, sample size considerations, randomization schemes, and statistical analysis planning.

We prepare Statistical Analysis Plans (SAPs) and perform analyses in accordance with regulatory guidelines and predefined methodologies. Close collaboration between statisticians and data managers ensures alignment between data collection and analytical objectives.By combining experienced teams, a validated RDC/EDC platform, and secure in-house infrastructure, CRS delivers data management and statistical services that support data integrity, regulatory readiness, and confident clinical and development decision-making.
  • Highly Maintained Server Security set-up
  • Regulatory strategy and regulatory submissions
  • Study start-up and site activation
  • Clinical trial planning and study design
  • Clear participant information and informed consent
  • Conducted in compliance with ICH-GCP and EU regulations
  • 24/7 safety monitoring and emergency readiness
  • Qualified investigators and trained study teams
  • Confidential handling of participant data

20+ Years

Of Experience in Early-Phase Clinical Research

Phase I Unit

Infrastructure organized across two dedicated units for controlled inpatient studies

EU Certified CRO

Slovenia, European Union regulatory environment

GCP Compliant

Conduct under international quality standards