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PROMETRIKA, LLC. is a full-service CRO whose clients include national and international biopharmaceutical and medical device companies. In the clinical research environment, even “simple” studies become significant projects spanning multiple companies, teams, investigators, and regulatory bodies. Given such complexity, our Project Managers (PMs) are critical to effective management of all services and functions that contribute to the success of a project.
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I had the opportunity to attend the 2023 PHUSE conference and explore the latest advancements in clinical data analysis through engaging workshops and presentations. Key topics included CDISC Analysis Results Standards, SDTM mapping recommendation engines, incremental automation using machine learning, and Leadership and professional development. The conference provided valuable insights into emerging trends and technologies that are shaping the future of clinical research.
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Over the past 15 – 20 years, projected peak sales and return on investment (ROI) of new drugs has been shrinking (source: Statista and Deloitte Centre for Health Solutions). To offset this, pharmaceutical companies are pushing to get more drugs to market and multiple indications for each agent.
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Decentralized clinical trials (DCT) seems to have burst on to the scene in just the last few years, so it is easy to get swept up into how we can best implement them into our clinical trials. However, it is worth examining the past of this supposedly “new” method of conducting clinical trials.
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The European Parliament and the Council of the European Union approved the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/279) which became enforceable on May 25, 2018. Because personal information, including health information, is collected during clinical trials, knowing and understanding the GDPR is critical for running clinical trials in the European Union. Penalties for infringements of specific provisions of the Regulation can reach up to 4% of a company’s total worldwide turnover (i.e., gross revenue).