| Service / Data Management | |
Kinship evaluates the trial in the design phase in order to create an efficient data management process, specific to client requirements. In this way our Data Management (DM) group can deliver a clean, locked database with a minimal amount of errors, delivered on time and within budget.
Our DM group meets most of your data management needs:
CRF
design
Database
construction
Data
entry and verification
Data
validation
Data
coding
Kinship uses its home grown product for Online Data Capture called 'KinEDC'. It also uses other third party products for its data capture such as Oracle Clinical, ClinSource TrialXS®, PhaseForward® ClinTrial® in a standardized, validated and documented environment as recommended or owned by the Client.
Our systems,
SOPs, and personnel are equipped to manage all 3 methods of data capture:
Paper
- Traditional paper method
- Traditional paper in combination with web-based
query management
Fax
EDC– Web or Remote Data Entry
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
Database
Documentation- Database transfer in Sponsor defined formats (ASCII, SAS, etc.) with detailed documentation
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 and BNF)
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
