Medical Writers – Who We Are and What We Do

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Medical Writers – Who We Are and What We Do
Medical Writers – Who We Are and What We Do

Clinical research, like any scientific research, entails many components and demands a plethora of skills. A clinical Investigator should be a master of knowledge in the specific field(s), constantly keeping up with the relevant developments and innovations. For the proposed drug, device or procedure, the Investigator should be able to develop an efficient and detailed …

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Risk based Data Management, nay targeted data review
Risk based Data Management, nay targeted data review

There is no doubt that our clinical trial designs are getting more complex by the day. This, however challenging, is a result of progression in the industry and is unavoidable. From a Data management (DM) perspective, the result is more complex CRF designs, more and highly complex edit checks and of course data source proliferation. …

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Biostatistics, Data Management, and Medical Writing: a Multidisciplinary Approach to the Development of the CTD Integrated Summaries
Biostatistics, Data Management, and Medical Writing: a Multidisciplinary Approach to the Development of the CTD Integrated Summaries

Published in Medical Writing Magazine, Volume 29 Number 2 | June 2020 Authors: Shiri Diskin, Tanya du Plessis, Ofra Barnett-Griness Abstract Analyses of integrated databases of efficacy and safety are a Food and Drug Administration (FDA) requirement. They are very useful in evaluating the safety and efficacy data gathered in multiple clinical studies. However, their utility is dependent upon the …

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A Guide to the Multifaceted Role Biostatisticians Play in Clinical Research
A Guide to the Multifaceted Role Biostatisticians Play in Clinical Research

Alongside data managers, statistical programmers and medical writers, biostatisticians play an integral role in the collaborative effort to develop new drugs and devices. And that’s because biostatisticians are involved in every step of clinical research – from study design to protocol development to data management and monitoring to data analysis and clinical trial reporting to …

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Case Study: Preparing a New Drug Application with a CDISC Conversion
Case Study: Preparing a New Drug Application with a CDISC Conversion

Regulatory submissions are the most critical milestones in clinical research programs. Quality submissions can accelerate time to market, maximize research investments and bring the benefit of new treatments to patients sooner. In August 2018, when the time came for RedHill Biopharma (Nasdaq: RDHL) to prepare its New Drug Application (NDA) for Talicia® (omeprazole magnesium, amoxicillin …

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Data managers in a changing technological landscape
Data managers in a changing technological landscape

Technological advances, providing better and quicker way for collecting increasing amounts of data, pose a challenge for data managers. With utilizing new technology being inevitable, and with all data processing activities being focused in a direction which requires less human review and more human oversight, how do we prepare our current work force to embrace …

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AI in data management
AI in data management

Growing amounts of collected clinical data augment the importance of reassessing the methods used for data processing and managing. Risk-based monitoring of the collected data is an integral part of any quality management program, it is an obligatory demand of the regulatory agencies and it substantially contributes to reducing the probability of costly failures (Hawwash, …

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Getting Closer to Source Data
Getting Closer to Source Data

As one stands in the booth hall of any conference on clinical trials, one will see an array of different technology vendors all looking to fill a space in the technology front of clinical research. Though the proposed new developments are not necessarily aimed to fill the same void, there is one specific area which …

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Levels of Scientific Evidence
Levels of Scientific Evidence

The hierarchy of scientific evidence is a concept from the field of evidence-based medicine. Most physicians strive to offer care that is grounded in scientific evidence, but while it is generally accepted that randomized controlled trials (RCTs) are the gold standard for support of a medicinal claim, the differences in scientific strength between other types …

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