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Data Management
Setup
Ongoing
Database Lock
🟠 Data handling protocol
🟠 Source workbooks (CRF) Design
🟠 EDC – Medidata (Rave) Partner, Castor, VieDoc
🟠 EDC Validation checks
🟠 CRF Completion Guidelines
🟠 Data Transfer Agreement
🟠 Safety Specification
🟠 Data Entry
🟠 Query management
🟠 Interim Safety data for dose escalations
🟠 Ongoing data visualisation for medical oversight
🟠 Medical coding
🟠 Data reconciliation
🟠 Medical Coding
🟠 Data Visualisation
🟠 Data and SAE Reconciliation
🟠 Critical 10% DRM
🟠 Primary endpoint data QC
🟠 Data Review Meeting
Quick setup: Using standard processes the study setup is complete within 3 weeks.
Adaptive trials: Ability to manage studies with adaptive design with equivalent efficiency as other studies.
Interim safety data: Rapid delivery of interim safety data within 2 days for dose escalation decisions
Efficient and Quality-Oriented Data Science for Clinical Trials.
Skilled data management team with over 17 years of experience consistently delivers exceptional data quality. With the ability to efficiently handle substantial amounts of data, the DM team provides comprehensive support and expertise in all stages of drug development. This includes data collection, cleaning with validation and quality control for clinical trial data.
The services offered by Richmond Data Science can be contracted as an independent service or as part of full service.
Efficiently upholding the highest clinical trial standards
