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Get the latest updates, insights and best practices on data management and biostatistics in clinical trials.

LEVERAGING MACHINE-LEARNING FOR SDTM MAPPING

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 …

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CMC Considerations

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, …

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Introduction to CMC

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 …

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Introduction to software as medical device (SaMD)

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 …

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Handling Peer Review Feedback: Stay Cool, Calm, and Collected

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 …

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Managing a multi-stakeholder writing project

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 …

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The QC Process for CSRs

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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