Clinical Trial Support
The steadily increasing costs and regulatory requirements associated with Phase I - Phase IV Clinical Trials make it imperative that project strategies address all critical aspects of the Trial. During the last decade, many pharmaceutical and medical technology companies have found that outsourcing procedures is an efficient and reliable solution to their clinical trial requirements.
Current Clinical Trial (GLP) Support Services
Quality Systems
- Regulatory Compliance (GLP, CLIA).
- Inclusive quality control criteria and standards.
- Dedicated Project Director.
- Dedicated and customized processes for each project.
- Procedure, Equipment and Training Validations.
- Advanced automation.
- Assay/procedure reproducibility.
- Infrastructure and systems that address critical Clinical Trial requirements.
SeqWright is uniquely positioned with the experience, know-how and capacity to deliver secure, timely, accurate and QA reviewed results.
Clinical Trial Data Management
- Sample De-identification and Tracking.
- Continuous real-time tracking via LIMS.
- Complete data security and integrity from sample receipt to data delivery on a closed-system.
- Multiple layers of security.
- Secure FTP site for data retrieval.
- Limited-access fire-proof storage.
- Redundant multi-site data backup systems.
- Project specific Bioinformatics solutions.
- Secure data delivery as regulatory compliant reports in client required format.
GLP Facility and Operations
- State-of-the-art facility specifically designed to maximize quality and process flow, while minimizing potential contamination.
- Unidirectional work-flows.
- Dedicated clean rooms.
- Emergency power for all processes.
Custom Solutions for Clinical Trial Services
- Consultative approach study design.
- Tailor made reports to meet individual project requirements.
- Post-project consultation available for data analysis.
- Learn more about SeqWright’s Quality Assurance Program.
We understand that every Clinical Trial is different and that is why we pride ourselves on our ability to customize our services, while retaining full regulatory compliance, to meet the unique needs of your Clinical Trial. Our dedicated staff will work with you every step of the way to validate your assay, address questions or concerns, and provide you with timely progress reports and full documentation.
Contact a sales representative about these services.
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