About
Over the years, we have gained extensive experience in the presentation and interpretation of data into well-structured, clear scientific documents. Emtex has contributed to several successful submission dossiers. We can support your company in the preparation of the documentation needed to speed up the development processes on the way to regulatory submission and approval. An overview of the most common regulatory medical writing services is provided here.
This product is intended for
- Medical Writer
- Senior Medical Writer
- Manager Medical Writing
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Emtex Regulatory Medical Writing
We have handled many small and large medical writing projects from various clients over a wide range of therapeutic areas, document types and for different audiences.
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Investigator’s Brochure (IB)
An Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data of an investigational product relevant to the study of this product in human subjects. Its purpose is to provide the investigator and others involved in the trial with understanding of the rationale for, and assure their compliance with, key features of the protocol (such as dose, frequency/interval, methods of administration, and safety monitoring procedures).
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Clinical Trial Protocol (CTP)
A Clinical Study Protocol (CSP), sometimes also referred to as Clinical Trial Protocol or simply as Protocol, is an overview of how the study will be executed, it contains a description of the study objective(s), design, methodology, statistical considerations, and organization of the study. Background information and the rationale for the study can be provided within the CSP or, if preferred, in other referenced documents.
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Clinical Study Report (including narratives) (CSR)
A Clinical Study Report (CSR), sometimes also referred to as Clinical Trial Report, is an integrated report of the clinical trial of any therapeutic, prophylactic, or diagnostic agent for submission to the health authorities. It provides a clinical and statistical description, presentations, analyses, and appendices with further details. Its purpose is to present the methodology used (including changes to the protocol) and data obtained.
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Risk Management Plan (RMP)
A Risk Management Plan (RMP), required in the European Union, is a description of a medicine’s safety profile; how its risks will be prevented or minimized in patients; plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine; measuring the effectiveness of risk-minimization measures. Its purpose is to document the risk management system considered necessary to identify, characterize, and minimize the medicinal product’s important risks.