Stringent quality system in place to ensure quality data are generated.
From database creation to database lock, Clinart provides conscientious care at every stage of data management, insuring reliable and verifiable data points.
Our comprehensive experience, stringent quality system and personalized performance-driven approach ensures our clients receive quality data on time, Every time.
- Selection of Appropriate Technology and Processes for each Study Design/Development of Case Report Form/ eCRFs., CDASH, CDISC.
- Strong experience in QoL questionnaire license as well as translation.
- Establishment of the Data Management Plan (DMP) and Data Validation Plan (DVP) including automated and manual rules identification.
- Database Design, Development and User Acceptance Testing.
- Working across three different platforms 21CFR Part 11 compliant according to the study design.
- Data Validation Checks Specification, Programming and Testing.
- Patient/CRF Tracking, Entry, and Verification.
- Double Data Entry, Automated Double Data Comparison and Synchronization.
- Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation.
- Medical Coding (MedDRA, WHO-DD, TMS or Sponsor-developed).
- Integration and Verification of External Electronic Data.
- SAE Reconciliation.
- Remote Data Access.
- Standard CRF/eCRF and Query process Metrics, Trends, and Data Reporting.
- In-stream Patient Closure and Quality Control Auditing.
- Evaluability Meeting Preparation and Attendance.
- Accelerated Database Lock & Final Archiving and Imaging.
completed study data processing & CSR production
1 MILLION CRF