Data Integrity First
Clinical Data
Management
Ensuring unparalleled data quality, integrity, and security through industry-leading EDC technology and rigorous regulatory compliance from Phase I to IV.
21 CFR Part 11
ALCOA+ Standards
GDPR/HIPAA
CDM Workflow
EDC System Design
Real-time Data Validation
Regulatory Submission Ready
Secure, Compliant, and
Quality-Driven
Our data management team is dedicated to offering the highest possible data integrity and security. Utilizing industry-leading **Electronic Data Capture (EDC)** technology, we provide complete support for your clinical trial data assets.
21 CFR
Part 11 Compliant
GAMP 5
Validation Ready
HIPAA
Data Security
EDC
Industry Leading
"From eCRF design to database lock, our processes are optimized for precision and regulatory excellence."
- ✓ Full support from Phase I through Phase IV
- ✓ Robust Medical Coding and SAE Reconciliation
- ✓ Comprehensive DM metrics and status reporting
Clinical Data Workflow
A structured approach to managing the lifecycle of your clinical data.
Study Initiation Phase
- DMP Preparation & CRF Annotation
- eCRF Design & Screen Testing
- Edit Check / DVP Development & Testing
- UAT & Database Go-Live
01
Study Conduct Phase
- Data Cleaning & Query Management
- Medical Coding & Ongoing QC
- SAE Reconciliation & Listing Review
- DM Metrics & Status Reports
02
Study Closeout Phase
- Pending Query Resolution
- Final Coding & Blind Data Review
- TLFs Dry Run & Investigator Signatures
- Database Lock & Final Archive
03