{"id":18,"date":"2024-02-05T18:27:37","date_gmt":"2024-02-05T18:27:37","guid":{"rendered":"http:\/\/localhost\/?page_id=18"},"modified":"2025-09-12T15:38:54","modified_gmt":"2025-09-12T15:38:54","slug":"quality-assurance-compliance","status":"publish","type":"page","link":"https:\/\/www.fsf-dev.org\/frontier\/services-solutions\/quality-assurance-compliance\/","title":{"rendered":"Quality Assurance & Compliance"},"content":{"rendered":"\n
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Quality Assurance & Compliance<\/h2>\n\n

Our integrated quality management systems ensure overall compliance with both domestic and international research regulations. <\/p><\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Overview<\/h2>\n\n\n\n

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.\u00a0<\/p>\n\n\n\n

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Project Management<\/h2>\n\n\n\n
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  • Data Migration Validation Services<\/li>\n\n\n\n
  • SOP Development<\/li>\n\n\n\n
  • Quality Event Management\/Corrective and Preventive Action (CAPA)<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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    Validation & Quality Checks<\/h2>\n\n\n\n
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    • Quality Management System (QMS)<\/li>\n\n\n\n
    • Commercial of the Shelf (COTS) Validation<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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      Audit Readiness<\/h2>\n\n\n\n
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      • Trial Master File (TMF) Audits<\/li>\n\n\n\n
      • Vendor Qualification and Audits<\/li>\n\n\n\n
      • Internal Audits<\/li>\n<\/ul>\n<\/div>\n\n\n\n
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        Compliance Training<\/h2>\n\n\n\n
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        • GCP and other Regulatory Training<\/li>\n\n\n\n
        • Training<\/li>\n\n\n\n
        • Regulatory Inspection Preparation<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
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          All Phases of the Study Lifecycle<\/h2>\n\n\n\n

          Our quality team is familiar with the regulatory aspects of all phases of the study lifecycle including:<\/p>\n\n\n\n

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          Conduct Gap Analyses<\/p>\n<\/div>\n<\/div>\n\n\n\n

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          Draft Standard Operating Procedures<\/p>\n<\/div>\n<\/div>\n\n\n\n

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          Set Up Quality Assurance Workflows<\/p>\n<\/div>\n<\/div>\n\n\n\n

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          Track Latest Protocols & Regulations<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

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          Comprehensive Quality Management Plans<\/h2>\n\n\n\n

          We assist with audit preparation, vendor selection and management, computer systems validation, trial master file implementation, incident and CAPA management, risk analyses, and any other topics relevant to a comprehensive Quality Management System (QMS).<\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n

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          Our Quality Team<\/h2>\n\n\n\n

          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.<\/p>\n\n\n\n

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          We also partner with our highly-talented Technical Writing department to provide tailored documentation, training materials, and full validation suites.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n

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          Quality Assurance Process<\/h2>\n\n\n\n
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            Consultation<\/h3>\n\n\n\n

            A regulatory consultation is conducted to discuss the unique aspects of the study and determine the overall goals of the collaborator<\/p>\n\n\n\n

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            Analysis<\/h3>\n\n\n\n

            A detailed gap analysis identifies potential compliance gaps and establishes approaches best suited for project needs<\/p>\n\n\n\n

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            Development<\/h3>\n\n\n\n

            A strategic plan is created based on project requirements, including flexible workflows, tailored documentation and training, and full software validation suites where required<\/p>\n\n\n\n

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            Implementation<\/h3>\n\n\n\n

            Our expert team provides direct assistance to ensure the successful implementation of customized workflows<\/p>\n\n\n\n

            \"\"<\/figure>\n<\/li>\n<\/ul><\/section>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

            Our integrated quality management systems ensure overall compliance with both domestic and international research regulations.<\/p>\n","protected":false},"author":1,"featured_media":1083,"parent":354,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-18","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/pages\/18"}],"collection":[{"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/comments?post=18"}],"version-history":[{"count":33,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/pages\/18\/revisions"}],"predecessor-version":[{"id":2356,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/pages\/18\/revisions\/2356"}],"up":[{"embeddable":true,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/pages\/354"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/media\/1083"}],"wp:attachment":[{"href":"https:\/\/www.fsf-dev.org\/frontier\/wp-json\/wp\/v2\/media?parent=18"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}