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Medical Writing

  • Upcoming Outreach Events in Medical Writing!

    Posted on 3/10/2017 12:46 PM

    Upcoming Outreach Events in Medical Writing...

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  • Expanding the Discussion: Assessing CV Safety in Clinical Research

    Posted on 2/25/2014 4:30 PM

    Clinical drug trials are always challenged with creating clear, standardized definitions of cardiovascular (CV) event outcomes that can be easily agreed-upon and evaluated by regulatory agencies. As data from several different clinical trials are frequently compiled to gain a fuller understanding of the investigational drug, it is important to use definitions that can be recognized across various studies. CV endpoints currently being examined in clinical studies are usually based off of a custom

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  • Modern Approaches to Assessing CV Safety in Clinical Drug Research

    Posted on 1/28/2014 4:32 PM

    Cardiovascular (CV) events have always been a prime focus in clinical drug research, but have been of increased concern to the FDA in recent years. In 2007, a well-publicized meta-analysis by Nissen and Wolski identified an increased risk of myocardial infarction and death due to CV causes associated with the anti-diabetic drug rosiglitazone1. The FDA Endocrinologic and Metabolic Drugs Advisory Committee met in July 2008 and determined that concerns about CV risks during premarketing and postmar

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  • An Interview with a Principal Medical Writer

    Posted on 10/25/2013 10:37 AM

    A medical writer plays a key role at various stages of drug development. They are vital in their role as they often lead the summarization and discussion of the data a company gathers over the course of developing a drug and even beyond. Although a medical writer is well known throughout the pharma industry, few outside of the industry know who a medical writer is or what exactly they do. Without a written record of clinical studies, new pharmaceutical drugs would never gain approval by the

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  • Pharmaceutical Regulatory Writing and Submissions 2013: Conference Recap and Highlights

    Posted on 3/31/2013 11:49 AM

    The 2nd annual Pharmaceutical Regulatory Writing and Submissions conference was held in Alexandria, VA on May 6th and 7th, and provided an exciting opportunity to exchange information and experiences with other industry leaders in medical writing and regulatory submissions. The conference covered a broad range of topics from content authoring, writing and submissions technologies, and complexities and strategies for global submissions. With presentations varying from case studies to panel discus

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  • How to Build a Document Review Team: A Medical Writing Guide

    Posted on 10/11/2012 10:45 AM

    Whether it’s the completion of a clinical study report (CSR) for a clinical trial, or the completion of a submission document for a drug development program, medical writing represents the culmination of many people’s work over the course of many years. Due to the number of stakeholders involved across multiple functional areas, medical writing tends to be a consensus‑driven process, representing many contributor’s thoughts and ideas. Building the right review team can significantly contribute t

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  • What NOT to Do When Writing a Clinical Study Report

    Posted on 8/17/2012 11:52 AM

    Clinical study reports (CSRs) describe the methods and results for each individual clinical trial. CSRs are included in the clinical part of the submission, so it’s important they are well written and easy to understand. As almost every clinical trial protocol is unique, the CSRs that describe their results will also need to be uniquely crafted. There are ICH guidelines (ICH E3) about what to do in the CSR but here are a couple of informal tips about what NOT to do when writing a CSR: Ignore th

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  • Setting Ground Rules for Medical Writing Document Review

    Posted on 8/8/2012 12:01 PM

    A medical writer often has to be a jack of all trades in order to ensure accurate, on-time completion of clinical documents. Document review provides a critical opportunity for the medical writer to elicit value-added review from team members. The medical writer can lead strategically by clarifying team members’ roles and responsibilities, setting clear expectations for reviewers, and setting “ground rules” for document reviewers at the outset of the project. The below are suggestions for medica

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