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| Global |
1 866 629 7100 |
| Local |
402 697 6500 |
| E-mail |
General Inquires |
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Qualia employs a highly trained staff proficient in statistics, programming, database design, and GCPs. Our team is well-trained in the regulatory requirements governing these sectors and is well versed in meeting stipulated audit standards for all data handling, analysis, and report writing. Qualia has the expertise to manage and analyze data for Phase I, II, III, and IV clinical trials. From the CRF to final report, we use only the most efficient and acceptable processes that meet audit standards. Qualia provides databases designed according to statistical and clinical needs, database programming using SAS, data entry, data validations, query generation and management, and report generation.
Data Management and Statistical Capabilities
Qualia has the expertise to manage and analyze data for Phase I, II, III, and IV clinical trials. From the CRF to final report, we use only the most efficient and acceptable processes that meet audit standards. Each project that we undertake is guided by a "charter" that defines:
- the scope, expectations, goals, and timelines
- the roles and responsibilities of each project team member
- specific needs (e.g. coding dictionary, final SAS transport files)
- reports required to meet the team's needs
- the milestones and deliverables as they relate to the cost quotation for services
Our capabilities include the following
- databases designed according to statistical and clinical needs
- database programming using SAS (coded to "black box" standards and sign off with full documentation)
- data entry (double entry and comparison)
- data validations
- query generation and management · report generation
Facilities and Systems
- Windows XP network, Intel-based office and communications servers
- Dell server for data management and SAS
- secure facility access
- daily backups of all system
- disaster recovery plan in place
- full SOPs
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