Any scientific report/document should be composed in a clear, concise and compliant way. It should clearly convey the scientific information without any ambiguity and misrepresentation. To ensure that the documents related to clinical, non-clinical and other medical affairs are aligned with industry standards, organizations may face a difficulty in performing thorough quality check pertaining to structure, formats, Standard Operation Procedures (SOPs), grammar, authenticity and accuracy of medicinal information, the structural flow, logical interpretation etc.
Designating project-specific reviewers, Freyr undergoes a rigorous review process to assist organizations with the highest quality of documentation. Freyr’s quality control and medical affairs services follow a robust quality check process where every document has its own quality process map and checklist which ensures that the document reaching the client is of utmost quality in terms of scientific, language, grammar and format and is submission ready. Freyr deploys an independent quality control (QC)/review team which works independently and not as part of core medical writing team, to ensure biasing is avoided.
- This review ensures that the document is prepared with good quality in terms of transcribing information from the source documents, correctness of the data structure, diligently followed relevant style guide, SOPs, template, formatted correctly, and grammatically correct.
- This review ensures that the document is medically and clinically interpreted correctly without missing any medical information from the source document. The medical reviewer would be the authorized signatory for some of the Regulatory documents to ensure that the data/information presented in the document is correct.
- This review ensures that the concept is covered appropriately with proper flow in the document, the information is interpreted correctly and overall the document is scientifically and logically conveying the purpose and intent of the document.
- This review is performed by the domain expert. The expert reviewer looks in the scientific correctness of the data generated, presented and interpreted in the documents. Expert reviewer would be the authorized signatory of some of the Regulatory documents to ensure that the data/information presented in the document is correct.
- Robust medical writing quality control with detailed and precise process map & checklist making the delivery of submission-ready document to the client
- Well-experienced QC team with Regulatory domain expertise ensuring thorough quality check of the document within reduced timeframes