HighPoint Blog

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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Setting up a tender organization for life sciences can be a challenge. Not only do you need to deal with the way the tender governance is structured, on top of that, depending on your leadership, you may have to organize your company accordingly. As promised, this blog addresses another even more complex aspect of the organizational design, being “how the lifecycle of your portfolio impacts...

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Harmonization of the tendering process seems like a tremendous task. Local laws are so different from country to country, making you ask yourself, how can it be achieved? Also, what are the benefits of harmonization and how can a tendering organization accomplish it? This blog focuses on discussing these aspects.

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Getting your EDMS in place

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Time to relax or time to do more work?

Q4 2018 may seem far, far away, but there is still lot to prepare for between now and then.

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In our first Life Science R&D blog, Paul Nelson talked about the major data challenges facing our industry today. Ultimately, those challenges boil down to what our team refers to as the volume, velocity, and variety of data.

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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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As anyone in Life Sciences already knows, every second of every day in R&D we are surrounded by data. We have pre-clinical data, clinical data, submission data, FDA correspondence, and operational data, just to name a few. Seeing it listed like that, pre-clinical and clinical data especially, seems like just part of a daily routine. But the truth is, developing drugs, biologics, medical...

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