Clinical Data Strategy
Built for GI
High-quality GI studies require rigorous endpoint definition and controlled data flow across systems and sources. We design data strategies and flows that:
Align with protocol
Ensuring endpoints and objectives are mapped correctly from the start
Leverage standards
Utilizing our GI-focused global library (CDISC aligned) to accelerate setup
Integrate sources
Seamless integration of key data sources including EDC, eCOA, IRT, imaging, and labs
Optimize PROs
Maximizing our PRO library, including pre-translated stool diaries, to improve patient compliance
Purpose-Built Data Capture and Workflows
We bring trial design to life with your end goal in mind, ensuring the right data are collected the right way through:
System setup
Electronic data capture (EDC) configuration, roles/permissions, and integrations (eCOA/ePRO, labs, imaging)
CRF design & edit checks
Case report form (CRF) aligned with the schedule of events and endpoints, GI-focused CRF library, edit checks, and user acceptance testing (UAT)
Data cleaning
Data listings, trend reviews, data visualizations, minimal and meaningful queries
Coding and reconciliations
MedDRA/WHODrug coding; AEs/SAEs, con meds, labs, and central reading results
Data transfers and standards
Data transfer agreements, validation, and mapping to CDISC SDTM/ADaM with traceability
Documentation
Data management plan (DMP), data validation plan (DVP), and controlled change management records
Quality & training
Well-defined workflows, access controls, and ongoing training
Seamless Collaboration for Exceptional Execution
Clinical data science sits at the center of study execution. We work closely with clinical operations, medical monitoring, safety, imaging, and biostatistics — keeping endpoints aligned and traceable, supporting confident execution of interim analyses, and ensuring the final analysis accurately reflects the study.
Confident Database Lock — With Fewer Surprises
We accelerate database lock (DBL) by keeping the end in mind and adjusting proactively throughout the study. This lock readiness approach includes:
- Data freeze and reconciliation checkpoints
- Clear approval pathways
- Validated transfer sequences
… all to ensure your final dataset is delivered clean, analysis-ready, and on time.
