Data Management Services

NCRA Data Management team's main mission is to provide clients with accurate, validated data rapidly and at competitive cost. NCRA is extremely capable, providing swift and efficient ways to collect and handle data using cost-effective technology to serve the systems and data-management needs of our clients.

One of the primary tools that NCRA uses, the Clindex® Clinical Trial and Data Management System, can accommodate hard copy or electronic data capture, specific to the client’s needs. This system not only provides excellent data management capabilities but also a comprehensive trial management system that allows the client to efficiently keep up on study status. We do have other data management options available if you should choose not to use Clindex.

Services NCRA provides:

Develop case report forms (CRFs)

• CRFs created per protocol specifications
• Printed and electronic CRFs
• Management and tracking of CRF versions and shipments
• Annotated CRFs

Data management (DM) documentation

• DM SOPs, development of project specific SOPs as needed
• Data coding conventions and coding memorandum
• Data entry guide

Management of the data

• Data entry, verification, and tracking
• Data logic/edit checks
• Rapid initiation/resolution and tracking of data queries
• Concomitant medication coding
• Adverse event and concurrent illness coding to MedDRA or other standard coding tools
• Verification of data transfers

Database development

• Clindex, or access and other vendor supplied database options
• Development of and adherence to data standards
• Rapid database lock
• Database archiving

Clinical study reports and specifications

• Interim reports
• Patient and study tracking reports
• Data safety monitoring board and other third party reports
• Database quality assurance reports

Clindex® Clinical Trial and Data Management Software

Utilise Clindex® Clinical Trial and Data Management Software, provide support for 21 CFR Part 11 Compliance, and meet all FDA regulations for clinical data management systems. To find out more please download this free white paper.