by Sharon Russouw 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 …
CMC Part 2. The drug manufacturing program for a pharmaceutical product is designed to collect information to ensure that the drug used in clinical studies is the same drug that will be commercially available to consumers. Chemistry, Manufacturing, and Controls (CMC) focuses on the rigorous analysis of the manufacturing process, quality control release testing, specifications, …
Introduction to CMC When new acquaintances learn that I have worked for over 10 years in the Pharma industry, I am frequently hit with a barrage of comments and questions – Why are medicines so expensive? Must medicines be thrown away the day after the expiry date? Do they become dangerous? How are new medicines …
By Liat Laufer Digital tools and applications have become integral parts of our daily lives. With their increasing prevalence, came an inevitable spread in the healthcare industry. One category of these tools is the software as a medical device (SaMD). The global SaMD market size was estimated to be USD 847.5 million in 2021[i]. Software …
By Fadwa Dabbah In the past, scientists often used only male subjects for experiments (females were under-represented) and applied the findings to both sexes. This caused unintended harm to females and economic loss. It has now become of great importance to emphasize considerations in integrating sex as a biological variable in all research, and especially …
By Daniela Kamir Academic manuscripts generally require revision following initial submission. If the authors, agree to implement revisions, it is good practice to prioritize the requested tasks to tackle the revision process as efficiently as possible. Take the revision process as an opportunity to improve your manuscript with the help of experienced professionals. A scientific …
Managing a multi-stakeholder writing project Research and development in the pharma and medical device industries involve many stakeholders (e.g., regulatory affairs, clinical, biometrics, clinical pharmacology, CMC, non-clinical), and thus a regulatory document almost always has multiple authors. Writing a regulatory document with multiple collaborators can be chaotic and time-consuming. Adopting a few of the principles …
The Five KYSes for Getting the Best Out of Your Medical Writing Vendor We often focus on what vendors should do in order to consistently deliver high-quality documents on time. There are, however, many things that the client can do to enhance the chances of getting what they need, when they need it. After …
By Danielle Hadar When starting QC work on a document, I first look through the entire document and its formatting to see if anything is out of place, whether the heading numbers are correct according to the E3 ICH Guidelines or if they need to be reorganized, and if the tables and figures are sequentially …
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