A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit trail review as a key tool to maintaining a high level of data integrity, particularly in high-risk scenarios when audit trails are used with regularity.  The paper is particularly timely as the availability of large…

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The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded in recent years.  Biostatisticians play a key role in the public health landscape, allowing scientists to support decisions made about patient…

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What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study. There are guidelines for CSRs which are defined in The International Council for Harmonisation of Technical Requirements for Pharmaceuticals…

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Miscommunication is Common, but Avoidable The quality of pharmaceutical research depends on many things, not least the biometrics of the study — that holy trinity of clinical data capture, manipulation, and reporting. When the interplay among those three functions goes smoothly, it’s a little like watching the graceful execution of a relay race. Communication is…

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Doctor using tablet in clinic

Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the medical and healthcare fields. What constitutes clinical data, what should you look for in that data, and what resources are there to manage data and data…

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Medical regulatory documents and a dictionary on the table. Medical translation service. Medical writing. Medical regulatory service.

Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage.  Examples of medical writing include: Research-based documents and scientific papers Educational materials on new diseases Promotional materials on new drugs or scientific applications…

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graphic Treximo News

CHICAGO, IL (October 19, 2020) — Treximo, a leading global life sciences consulting and solutions provider and part of The Planet Group, announced today that Scott Williams has joined the firm as Vice President of Business Development. Williams previously held the role of Vice President of Sales and Operations serving in the Life Sciences industries…

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In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the end goal of finding useful insights that deliver better products, workplace processes, and profit for the company, as well as consumer experiences. While financial, energy,…

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Drug development can be a protracted and multifaceted process. This is often the case for startups and newer organizations, which may not have dedicated regulatory compliance departments and established standard operating procedures (SOPs).  These organizations may seek regulatory consulting services to support submission strategies and develop the required procedures. According to Professor Thomas Koperniak of…

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COVID-19 has been the ultimate big pharma catalyst, as well as the biggest thing to hit biopharmaceutical news pages in decades. On the industry side, however, investors and observers remain mindful of non-COVID-related trends in biopharma. More accurately, trends well underway in January still deserve attention.  2020 Biopharma Trends to Keep an Eye On These…

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