Data Management Services

The TII data management team has experience with all aspects of clinical data management, including case report form design, application of various data capture technologies, query management, and ongoing quality control and assurance.

Whether your needs are paper-based, electronic, or a combination of the two, our data management systems conform with accepted industry standards and have been subjected to rigorous documented system validation and acceptance tests to meet regulatory requirements.

We develop in-house systems tailored to the client's needs including small scale Web-based Electronic Data Collection (EDC) systems, Web-based questionnaires and Web-based Case Report Form (CRF) tracking systems.

Services include:

• Study setup and design (database design/structures, screen creation, and schema)
• Study test (test plan and change control method)
• Case Report Form design and completion guidelines
• Case Report Form management (CRF flow and tracking)
• Data capture (technology specified and study specific data capture guidelines)
• Safety and efficacy data (guidelines and critical variable audits)
• Laboratory data (guidelines, reference ranges, format and frequency)
• Query management (frequency and method of validation, validation guidelines and edit specifications)
• Study deliverables (format and frequency)
• Data transfers (format and frequency)
• Database exports of CRF data (SAS, SQL, SPSS, Excel)
• Standard Reports (list of reports and frequency)
• Closing the study (database freeze/lock process)
• Security (access to application by users)
• Quality assurance (audit process and frequency)
• Revision history