Clinical Data Management Services
Complete CDM solutions from study start-up to database lock, coding & biostats.
At DataPro Solutions®, we offer comprehensive end-to-end solutions for your clinical data management needs. Our dedicated team, equipped with indication-specific expertise, ensures seamless support throughout your project—from protocol review to final dataset delivery.
Clinical Database Management Start-Up
Planning, EDC selection, CRF design, and data flow coordination
Customized Data Management Planning
Tailoring a data management plan that aligns with your protocol, study site demands, and unique therapeutic needs — including RTSM/IRT integration.
Optimal EDC Selection
Utilizing the best Electronic Data Capture systems—Medidata Rave, Oracle InForm, and Veeva Vault—matched to your project requirements.
CRF Design & Completion Guidelines
Crafting case report forms with detailed completion guidelines for consistency, clarity, and site compliance.
Efficient Data Coordination
Streamlining information flow from study onset — including external vendor data pipelines and specialty lab feeds.
Clinical Database Development
Database building, edit checks, testing, QC, and user acceptance training
Database Build, Edit Checks & QC Testing
Establishing robust databases with meticulous edit check programming, testing, and quality control to ensure data integrity.
User Acceptance Testing (UAT)
Collaborating with sponsors and study sites for comprehensive UAT—ensuring systems are validated and site-ready before the first patient in.
Clinical Database Conduct
Data cleaning, medical coding, SAE reconciliation, and metrics reporting
Data Cleaning & Query Resolution
Ensuring data accuracy and resolving discrepancies through systematic query management and site follow-up.
Medical Coding & External Data Integration
Streamlining WHODRUG/MedDRA coding and integrating external vendor data, including PK/PD, biomarker, and specialty lab feeds.
Safety Event Reconciliation
Diligent reconciliation of Serious Adverse Events (SAEs) between the EDC and safety databases to ensure regulatory compliance.
Metrics & Reporting
Ongoing EDC data metrics and detailed Clean Submit reports to keep sponsors, CROs, and clinical operations fully informed.
Clinical Database Lock
PI signatures, final datasets, CRF archival, and EDC decommission
Finalizing Lock Processes
Securing principal investigator signatures, resolving outstanding queries, and locking CRFs in preparation for statistical analysis.
Final Dataset Generation
Producing CDISC-compliant final datasets (SDTM/ADaM-ready) for biostatistical analysis and regulatory submission.
CRF Archival
Creating site CRF archival packages for long-term record-keeping and audit readiness per ICH E6 GCP requirements.
EDC Decommission
Safely decommissioning the EDC system post-study, including data extraction, backup, and system retirement documentation.
Biostatistical Services Collaboration
eCRF design, population definitions, CTCAE v6.0, and TLF review
Protocol-Compliant eCRF Design
Ensuring eCRF design strictly adheres to the Clinical Study Protocol, maintaining data capture integrity for statistical analysis.
Analysis Population Definitions
Assisting in defining ITT, safety, per-protocol, PK, and PD populations—including subgroup analyses by tumor type or biomarker.
CTCAE v6.0 & Adverse Event Analysis
Contributing to response criteria, clinically significant lab analysis, and adverse event grading per CTCAE version 6.0.
TLF Review & Validation
Participating in the inspection of tables, listings, and figures to ensure accuracy, completeness, and regulatory clarity.
WHODRUG & MedDRA Coding Services
Expert medical coding for global regulatory compliance
Accurate and consistent coding is critical to the success of any clinical trial. Data Pro Solutions provides specialist coding services using WHODRUG and MedDRA dictionaries, ensuring data is precise, standardized, and globally compliant.
WHODRUG Dictionary
Expert licensing facilitation and tailored dictionary version recommendations. We work closely with Medical Monitor and Regulatory teams to select the most appropriate terms — including organization-specific synonyms.
MedDRA Dictionary
Comprehensive adverse event and medical history coding for international regulatory submissions. Customized eCRF panel recommendations aligned with your study protocol and global regulatory requirements.
Ready to Discuss Your Study?
Partner with experienced CDM professionals for your next study. Reach out today.