Contract Research Organization CRO Clinical Data Management Scian Services

Data Management

SciAn Services is a large-scale data management CRO. Our approach is to provide our clients with clinical data management solutions that are customizable to client requirements, cost-effective, secure, regulatory–compliant, and expedite the data collection process, regardless of the data collection method our clients choose. Our systems, SOPs, and personnel are equipped to manage all 3 methods of data capture:

• Paper
• Fax
• EDC – Web-based data capture

Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:

- Quick database set-up
- Sponsor-defined CRF and DCF management rules
- Customized query wording for clarity and conciseness
- Accelerated query management
- Unscheduled data reviews
- Study timeline changes
- Changes to Protocol, CRF Template and project specifications

Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.

The following is a summary of our data management services and procedures:

• Data Management Plan
  - Project-specific data management standards and SOPs
• Database Design
  - Database definition
  - Database security
  - Data entry screens
• Data Validation Plan
  - Initial programming and query wording
  - Testing and locking data validation plan
  - Periodic re-testing
• Data Entry (paper)
  - Ongoing data entry from CRFs – single or double entry
  - Data entry cleaning
• Medical/Science Review
  - Review of marginal notes on CRFs and Data Alerts
  - Evaluating medical and scientific consistency of data
• SAE Reconciliation
  - Reconciliation based on central SAE database vs. study database
• Medical Coding
  - Coding of adverse events (MedDRA, WHO-ART, COSTART)
  - Coding of concomitant drugs (WHODRUG)
• Data Validation and Query Management
  - Periodic validation of CRF data
  - Flexible query routing
  - Accommodating 3rd party queries
  - Query and resolution management over the Internet
• Central Lab Database Imports
  - Incorporating 3rd party databases
• Database Lock and Audit
  - Interim and final database locks with associated documentation
• Database Documentation & Release
  - Database transfer in Sponsor defined formats (ASCII, SAS, and     XML, as per CDISC specifications) with detailed documentation

To ensure the integrity and accuracy of the study data our Project and Data Managers follow corporate QC and QA processes. Our QC process involves periodic review of: 1) CRF and DCF tracking and filing; 2) data entry errors and data management procedures; and 3) Data entry vs. original paper CRFs. Further, we QC the scientific integrity of the database by ensuring the consistency between the Protocol, SAS database and CRF Template. Our QA process formally assesses compliance with corporate and study-specific SOPs.

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