Whether we like it or not, inspections are a crucial part of clinical trials. It...
Phlexglobal has a wide range of experience with trial master file (TMF) and electronic trial master file (eTMF) requirements from a regulatory authority perspective.
The company’s team of experienced document experts and consultants will help prepare TMFs ahead of inspection through a selection of services at the sponsor site, contract research organisation (CRO) site, or at Phlexglobal’s offices.
The company follows established processes to ensure the highest level of quality is met.
Quality control services are divided into three levels:
1.1 Level 1 QC: Section level checking
This high-level check is to ensure artefacts are accounted for (absent or present) in the TMF. General standard of filing, including accuracy and reverse date ordering is also checked. The output of level 1 WC is a summary checklist detailing missing documents.
1.2 Level 2 QC: Document level checking
This includes high-level section checks as defined in level 1, including document quality checks for dates, signatures, versions, completeness, and cross-checks to ensure associated documents are present and complete.
Output is a series of reports based on the TMF structure under trial, country, or site, allowing data and findings to be assessed and presented in a variety of ways.
1.3 Level 3 QC: Compliance and oversight checks
This includes section and document level checking, as defined in level 2, including further review of documents and processes to check for compliance and oversight. Output is a comprehensive report customised to specific requirements.
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