Pharmaceutical Medical Writing Services
CONSULTING
CONTENT AND PROCESS CONSULTING
Our client needed to optimise the authoring and production of Investigator Brochures (IB) as part of their clinical regulatory writing efforts for a new drug application.
Red Thread recognised that this was a company-wide issue. The problem was not limited to tools, but required an assessment of the interaction of operational functions within the organization.
Our consultants reviewed the IB documents for each product, assessed the client’s existing process, and interviewed each functional stakeholder. We were able to identify areas for improvement and continued to work with the client to implement our recommendations.
LEGACY DOSSIER CONVERSION
CONTENT RETRIEVAL, REVIEW, TRIAGE AND CONVERSION
A client required the conversion of a legacy dossier to meet current standards, ensuring that the content was updated to incorporate new data for submission into new territories, including a new drug application. The list of clinical studies was defined and categorized for assessment of relevance to Module 5. Archived study reports were retrieved, and paper components were scanned. Simple navigation was added to the scanned documents to aid review. Each study report was reviewed against current regulatory standards and against the company pharmacovigilance (PV) database. Missing components located in the archived trial master file (TMF) were scanned and added to the report. New content was authored where necessary, including investigator brochures and case narratives for significant adverse events. Components were approved in a submission-ready format appropriate to legacy studies.
DOSSIER CREATION
PARALLEL AUTHORING AND CONTENT MAPPING
Our client required a new drug application (NDA) for an eCTD submission in the US that involved parallel authoring of the pivotal clinical study report (CSR), an integrated safety summary (ISS), the clinical summaries of safety and efficacy, and the clinical overviews. This process is essential in clinical regulatory writing to ensure compliance and clarity in documentation.
Our authors collaborated with the client’s publishers to create templates for each document and define the overall submission structure. Early in the document development phase, our authors identified the red thread for each document necessary to support the proposed summary of product characteristics (SmPC). Reusable content was meticulously mapped to the appropriate sections of each document, including essential elements for the investigator brochures. The authors facilitated parallel document reviews and coordinated with other functional teams to ensure message consistency across the dossier and timely deliverables. Our authors worked closely with the publishers to ensure that each document was approved in a submission-ready format and compiled in an eCTD structure, ready for submission to the FDA.