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Integrated Summaries of Safety & Efficacy for Regulatory Submissions

Statistical Consultancy Team

Far from being simply a summary of individual results, a comprehensive and detailed summary allows companies to make informed decisions. Producing comprehensive integrated summaries of safety and efficacy is a critical stage of the submission life cycle. These need to be designed and planned carefully in advance to ensure informed decision-making and effectiveness at the regulatory interface. A focus on the approval and whole lifecycle of the product, and not just the submission, will influence the quality and direction of the content. Traceability is key in all respects of the creation of information, from data that leads to knowledgeable decisions and the ultimate wisdom that forms the label of a product.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Medical Writing, Biostatistics Consulting, Phase 3 Studies, Phase 2 Studies, Statistics

Regulatory Writing – An Integral Part of Clinical Research

Medical Writing Team

There are two main areas in medical writing, medical communications and regulatory writing; this blog focuses on the latter area of specialisation, which involves the preparation of clinical study and regulatory submission documentation.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

Celebrating Women in Science, Medicine and Mathematics

Marketing Quanticate

Happy International Women's Day! On this day, we wanted to celebrate the success of women within science, mathematics and medicine, and how they have helped shape the pharmaceutical industry in which we work. Without the hard work and success of these individuals, we may not be providing the level of healthcare currently available. Today, half of medical graduates are female, as well as doctors and top researchers, it is reported that the number of statisticians equals the number of men. Please read on to learn about some of the most influential women to celebrate international women’s day.

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Topics: Statistical Programming, Medical Writing, Clinical Programming, Drug Development, Nobel Prize, Women in Science

Compiling the Appendices for a Clinical Study Report

Medical Writing Team

For any clinical regulatory writer, compiling the appendices for a clinical study report (CSR) can feel like a daunting task, but it doesn’t have to be. To make this task easier and less time consuming you need to start thinking about it before you even begin to write the CSR.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

The Challenges of Writing Patient / Safety Narratives

Medical Writing Team

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.

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Topics: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control

Regulatory Writing: What Does it Entail?

Medical Writing Team

 

Regulatory Medical Writing is often overlooked in the world of Medical Communications.  Regulatory writing, though perhaps less glamorous then the production of conference brochures and magazine articles, is a vital facet of clinical research.

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Topics: Medical Writing, Regulatory Writing, Clinical Documents

Medical Writing Tips For Managing Multiple Priorities

Medical Writing Team

 

 

A Regulatory Medical Writer in a Clinical Research Organization (CRO) is usually involved at the start (writing a study protocol) and/or end (writing a clinical study report(CSR)) of a project. The start and end of a clinical study can be the most stressful time for the team as they work together to meet important deadlines. For the Medical Writer this stress can be further exaggerated by multiple projects converging and study teams demanding more and more of their time with last minute changes. The Medical Writer, as part of a team, will also have to do their fair share of quality control (QC) and/or peer reviewing.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

Becoming a Regulatory Writer

Medical Writing Team

Whether working for a pharmaceutical company or a clinical research organisation (CRO), most regulatory writers started out as academics.  Although a PhD is not a pre-requisite, most employers will be looking for a scientific or medical degree, not to mention certain character traits such as problem solving and analytical skills, fastidiousness and a readiness to embrace new fields of research.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

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We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

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