Audit trails are a regulatory requirement. How to take an RBQM approach. Audit trails have long been a regulatory requirement, proving to be a very important historical record of data recorded for clinical trials. These records facilitate transparency and accountability by allowing researchers, sponsors, and regulatory authorities to trace and verify the validity of the …
For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies, as well as nonprofits and academic medical centers, outsourcing is a necessity. It often isn’t feasible or cost effective to conduct all clinical trial operations – from study design through submission – in house. For that reason, when it comes …
By Dionne Crafford In the first of two posts on lean medical writing, we were introduced to the lean thought process, its origins, why it would be beneficial to apply it to medical writing, and how it can be applied in an authoring context. In this second post, we will look at specific strategies we …
By Dionne Crafford Word economy contributes to streamlined documents. Yet the process of “lean” embodies so much more. In 1913 Henry Ford created “flow production”, but the process allowed only limited variety. Toyota birthed the process of lean by revisiting Ford’s way of thinking. The process was distilled into five principles: identify value (customer perspective), …
By Fadwa Dabbah-Assadi Since 2016, emerging technological innovations have made clinical trial designs more diverse and complex, and increase the risk that stakeholders may fail to comply with the present/former E6(R2) guidelines.1 Consequently, the E6(R2) guideline was amended to the E6(R3) guideline (endorsed on 19 May 2023) by the International Council for Harmonisation of Technical …
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 …
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