Our expertise
CERC delivers integrated biometric and data management services that ensure the accuracy, consistency, and reliability of clinical data.
Our team of data managers and biostatisticians supports every phase of clinical research, from Case Report Forms (CRFs)design to statistical reporting, combining operational efficiency with scientific rigor.
We conduct all studies using electronic Case Report Forms (eCRFs), from first-in-man investigations to large multicenter randomized trials.
Who we support
Sponsors and research teams seeking a data-driven partner for the design, management, and analysis of clinical studies.
CERC provides flexible services that can be integrated into full trial management or delivered as standalone modules.
Engagement options
- Comprehensive biometric services: full data and statistics package for your study.
- Standalone support: CRF design, integrated into electronic data collection (EDC) system, data management, or statistical analysis only.
- Academic collaboration: advanced analyses through CERC’s partnership with Universities.
What we deliver
- CRF design, validation, and management using secure and compliant EDC systems.
- Data Management Plans (DMP) and Data Validation Plans (DVP) defining database structure, checks, and workflow.
- Randomization setup and management.
- Ongoing Data Management reporting: monthly DM Status Reports providing a snapshot of study progress (EDC signatures, follow-up tracking, data quality metrics, and risk indicators).
These reports allow the study team and sponsor to monitor trends, anticipate issues, and implement risk-based corrective actions throughout the study. - Query management and data cleaning ensuring consistent data integrity.
- Statistical Analysis Plan (SAP) to predefine how the data in a study will be analyzed, in order to ensure transparency, consistency with clinical investigation plan (CIP) and credibility of the results.
- Statistical input for Data Monitoring Committees or Data and Safety Monitoring Board.
- Interim and final statistical analyses based on a validated SAP.
- Comprehensive statistical reporting ready for submission or publication.
Our process
- Plan: define data strategy, endpoints, and statistical needs.
- Design: create compliant CRFs and data flow structures.
- Collect: manage data entry, validation, and monitoring in real time.
- Analyse: perform statistical analyses aligned with the protocol and SAP.
- Report: issue periodic Data Management reports, clean datasets, and TLFs (Tables, Listings, Figures) for regulatory or scientific use.
- Archive: ensure secure internal and external archiving at study close-out.
Why CERC?
- End-to-end data expertise from CRF setup to final analysis.
- Certified systems compliant with ICH-GCP, GDPR, and 21 CFR Part 11.
- Experienced data management team with proactive risk-based oversight through periodic reporting.
- Academic collaboration with Universities for advanced statistical validation.
- Proven experience across all study types, from pilot to large-scale multicenter trials.
Typical deliverables
Validated CRF system, Data Management Plan, Data Validation Plan, monthly Data Management Status Reports, randomization list, Statistical Analysis Plan, clean database, interim and final statistical reports, and TLFs.
Sample outcomes
- Improved data quality and reduced cleaning time through proactive monitoring and DM Status reporting.
- Optimized decision-making using real-time risk indicators and data-driven corrective actions.
- Robust statistical validation supporting regulatory submissions and scientific publications.
Ensure data quality through proactive monitoring and insightful reporting.
Contact us to discover how CERC can enhance your data management and analysis strategy.
