Overview

Any scientific report/document should be composed in a clear, concise, and compliant way validated by stringent pharmacovigilance quality control systems. 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 the industry standards, organizations may face difficulties in performing a thorough quality check pertaining to the structure, formats, Standard Operation Procedures (SOPs), grammar, authenticity, accuracy of medicinal information, the structural flow, logical interpretation, etc.

By designating project-specific reviewers, Freyr undergoes a rigorous review process to assist organizations with the highest quality of documentation. Freyr’s pharmacovigilance quality control and medical affairs services follow a robust quality check process where every document has its own quality process map and checklist to ensure that the document reaching the client is of utmost quality in terms of scientific, language, grammar, format, and is submission ready. Freyr deploys an independent Quality Control (QC)/review team that works independently and not as part of the core medical writing team, to ensure bias is avoided.

 

Freyr Expertise

Quality Review

  • This review ensures that the document is prepared with good quality in terms of transcribing information from the source documents, the correctness of the data structure, diligently following a relevant style guide, SOPs, template, formatted correctly, and grammatically correct.

Medical Review

  • 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.

Peer Review

  • This review ensures that the concept is covered appropriately with the proper flow in the document, the information is interpreted correctly and the overall document scientifically and logically conveys the purpose and intent of the document.

Expert Review

  • This review is performed by the domain expert. The expert reviewer looks at the scientific correctness of the data generated, presented, and interpreted in the documents. The 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.
 

Freyr Advantages

  • Robust medical writing quality control with a detailed and precise process map & checklist making the delivery of the submission-ready document to the client
  • Well-experienced pharmacovigilance quality control team with Regulatory domain expertise ensuring thorough quality check of the document within reduced timeframes