HighPoint Blog

The industry is currently in a period of unprecedented transformation, driven by ongoing shifts in the regulatory sphere from document-driven to data-driven information management. This transition is certain to continue well into the next decade and poses a significant challenge to the industry, with profound impact on how we manage regulatory information going forward.

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It may be no surprise that during a sponsor audit, data management and source documentation rank among the top ten most common categories for critical inspection findings. According to a report on behalf of the European Medicines Agency (EMA), out of 398 GCP inspections over a 12-year period, a total of 5,685 findings were recorded; 532 of these findings were critical – 48 directly related to...

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Latest revision of ICH guideline updates required data elements for transmission of Individual Case Safety Reports (ICSRs)

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Managing the volume, variety and velocity of data is one of the best known—and least understood—challenges in the Life Sciences industry. According to IDC, data grows 50% year-over-year, which is significant. This tremendous growth is causing a major obstacle across the industry, specifically in the area of Research & Development.

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Written by HighPoint Solutions R&D Practice

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