By Anca Savulescu Scientific, technical, and medical writing have changed enormously as these writing-based professions have evolved. These professions have solidified over time, and now, clearer distinctions can be made between them, although the boundaries may still be gray. Firstly, a clear distinction must be made between science writing and scientific writing. Science writing is …
Background In October 2022, Abiomed, a leading provider of medical technology focused on mechanical circulatory support heart and lung recovery, announced that the U.S. Food and Drug Administration (FDA) accepted and closed all of the post-approval study reports related to the pre-market approvals (PMA) for the Impella heart pump. The announcement marked a significant regulatory …
By Nadia Nahmany Clinical trials are a critical step in the drug development process, and the effective management of data plays a crucial role in their success. After all, data forms the building blocks of information used to evaluate the safety and efficacy of new drugs and medical devices. The FDA, for example, outlines its …
By Dionne Crafford What criteria would need to be achieved for medical writing to be considered effective? Medical writing must be accurate (free of error) and concise (brief and free of superfluous detail), yet still engaging. The writer needs to convey a complex message to a target audience clearly and logically for interpretation. To be …
Bioforum the Data Masters is a leading data focused CRO specializing in medical writing, data management and biostatistics. With the introduction of the updated ICH regulations and the requirement to implement better risk management and surveillance over clinical data to ensure its integrity and high quality, it became increasingly important for Bioforum to find a …
Timing is critical in clinical trials, especially when it comes risk assessment. Earlier risk detection and intervention can prevent significant issues associated with data quality and patient safety, as well as spiraling costs and study delays – a shared understanding that drove the industry’s shift to risk-based monitoring (RBM). The approach’s success, along with advances …
Clinical trial sponsors and CROs who combine their operational data with clinical trial analytics are likely to get their therapies to market faster. Yet, some sponsors and CROs remain apprehensive about investing in analytics platforms due to cost constraints and concerns over which tools will best serve their needs. Today, however, the benefits of using …
Written by ChatGPT and edited by a Homo sapiens sapiens Manufacturing and Distribution Once a device has been cleared or approved, the next step is to identify and work with a manufacturing partner to produce the device. A quality management system must be established to ensure the device is manufactured in accordance with regulatory requirements. A …
by Sharon Rossouw EXECUTIVE SUMMARY Data standards support the robust organization, analysis, and reporting of clinical trials and many regulatory authorities mandate the use of standardized data structures for clinical trial submissions. The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) is a framework used to represent trial data in a standardized …
Written by ChatGPT and edited by a Homo sapiens sapiens Clinical Trials Clinical trials are an essential step in bringing a medical device to market. These trials are conducted to gather data on the safety and effectiveness of the device. The data gathered during clinical trials are used to support the safety and effectiveness of …
Written by ChatGPT and edited by a Homo sapiens sapiens Medical devices play a critical role in modern healthcare, from diagnostic tools to life-saving equipment. Bringing a new medical device to market is a complex process that requires a significant investment of time and resources. In this blog post, we will outline the key steps …
Introduction The submission of a New Drug Application (NDA) to regulatory authorities and its subsequent approval is an important milestone in the lifecycle of a drug, potentially leading to a novel or alternative treatment option for patients with severe diseases. About 73% of all NDAs are eventually approved. The most common reasons for unsuccessful first-time …
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