Clinical Data Management
Cispact’s Clinical Data Management services are the most efficient and reliable in collection, organization, validation, and analysis of clinical trial data. We at Cispact take our databases and information seriously and are hence, an end-to-end solution provider in the clinical data maintenance field. Our services are integrated in a way to assist right from Phase-I to post-marketing trials. Right from paper CRFs to EDC-based data management projects, the team at Cispact is trained at handling it all with utmost efficiency. We use a comprehensive 21 CFR Part 11 compliant that is user-friendly and commercially available in order to ensure the best integrated and qualitative result.
Study Setup Services
- Design and Development of CRF/eCRF by
Following the CDASH Standard - eCRF Specification
- CRF Annotation & Review
- Data Management Plan (DMP) Creation
- Database Build & Design and Maintenance
- Edit Check Specifications & Programming
- Data Loading Setup
- Dictionary Setup (MedDRA, WHODRUG,
COSTART, ICD-9) - IVRS/IWRS Integration
Study Conduct Services
- Reviews Clinical Data for Errors and Trends and Generates Electronic Queries and
Provide Resolution - Medical Coding
- SAE Reconciliation
- Third Party Data Reconciliation Post
- Production Change Control
- Standard & Customized Reports for Data
- Review & Metrics
- Data Transfer
Study Close out Services
- Data Export/Transfer and Interim Analyses
- Final DB Lock Readiness
- QC of Data Base
Database Audit by QA - Database Lock
- Conversion of Data to SDTM or Sponsor
Specifications - Study Close Out Documentation
- Clinical Study Data Archival /
Decommissioning
Other Services
- Quality and Compliance Check
- On-Shore and Offshore Clinical Data
Management Services