Overview
Frontier Science lends its expertise to the design, conduct, analysis, and reporting of clinical trials and observational studies. Our knowledgeable team is ready to customize solutions to meet your research needs.
Project Management
- Data Migration Validation Services
- SOP Development
- Quality Event Management/Corrective and Preventive Action (CAPA)
Validation & Quality Checks
- Quality Management System (QMS)
- Commercial of the Shelf (COTS) Validation
Audit Readiness
- Trial Master File (TMF) Audits
- Vendor Qualification and Audits
- Internal Audits
Compliance Training
- GCP and other Regulatory Training
- Training
- Regulatory Inspection Preparation
All Phases of the Study Lifecycle
Our quality team is familiar with the regulatory aspects of all phases of the study lifecycle including:
Conduct Gap Analyses
Draft Standard Operating Procedures
Set Up Quality Assurance Workflows
Track Latest Protocols & Regulations
Our Quality Team
To develop quality assurance workflows, the Quality Assurance department works closely with other organizational departments, including Software Engineering, Data Management, IT, Biostatistics, Randomization, Database Operations, CDISC, and User Support.
We also partner with our highly-talented Technical Writing department to provide tailored documentation, training materials, and full validation suites.
Quality Assurance Process
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Consultation
A regulatory consultation is conducted to discuss the unique aspects of the study and determine the overall goals of the collaborator
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Analysis
A detailed gap analysis identifies potential compliance gaps and establishes approaches best suited for project needs
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Development
A strategic plan is created based on project requirements, including flexible workflows, tailored documentation and training, and full software validation suites where required
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Implementation
Our expert team provides direct assistance to ensure the successful implementation of customized workflows
