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FDA/EU/MHRA/TGA Clin monitoring suggestions COVID

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There are several suggestions, recommendations from different health authorities for sponsors to handle clinical trial aspects during this very challenging time of COVID. Most of them recommended …
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For Labeling Teams, What Does 10 Minutes Saving Per Day Means?

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That’s 40 hours time saved per year. The more per day time saving, obviously means more time saved in addition. Use this time that you’ll save for your strategic planning, process optimiza…
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Most Common and Avoidable Mistakes While Adopting ISO 13485

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In the process of implementation of QMS standard ISO 13485, many companies face common struggles; however their mistakes can be avoided when you look and analyze these things more closel…
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Effectiveness and Flexibility of Adaptive Designs in Clinical Trials

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Drug development is becoming a complex process with each passing year. Expenses and time are not at per. Even success rates are dwindling over time and hence new drug development too loses the cha…
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Regulatory Data and Info Management for Med Device Success

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With EU MDR changing the plain field of med devices to a whole a new level, other countries are following similar path of increasing demands in product safety, traceability, performance areas. …
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