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Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in R&D experiencing historic growth year after year.  With such impressive growth comes a need for companies to have a sound R&D strategy. Here,…

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Covid Has Changed the Way We Communicate With more virtual interactions and less face-to-face exchanges, the COVID-19 pandemic has changed the way we communicate and connect with coworkers. Gone are the days of standing around the water cooler and making small talk with one another. Instead, at our home offices, we tune into Zoom calls…

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Medical teams are a critical part of the biopharmaceutical and device product lifecycle. Management depends on small medical teams to solve complex problems. Often, these small teams work under the added pressures of having their work linked to patient outcomes or important research developments. When medical teams are working with limited resources and manpower, it…

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COVID-19 has continued to dominate the headlines as we begin 2021. While mass media outlets focus closely on the current pandemic, those of us in the biotech industry know that future preparedness is just as important. In addition to pandemic research and development, other biopharma trends will get their share of headlines in the coming…

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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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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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