Data security in clinical trials underpins patient protection, data integrity, and regulatory compliance. ISO 27001 provides a structured, auditable framework that supports these requirements.
ALCOA++ principles are no longer just a good practice — they are a regulatory expectation. Learn how to translate them into system and process requirements for data collection and management in clinical trials.
Regulations such as ICH E6 (R3) GCP, EU Annex 11, and FDA 21 CFR Part 11 provide guidance - but their successful application requires a deep understanding of both technology and compliance.
Without sufficient statistical power, a study is doomed from the start and even the most promising treatments can appear ineffective.
Even a perfectly conducted clinical trial can end up answering the wrong question if the research objective is misaligned with the statistical hypothesis.
The importance of audits in clinical trials is beyond dispute. Why not audit something as important to the study as the Statistical Analysis Plan and minimize the risk of expensive consequences?
The belief that all phenomena in the Universe follow the normal distribution is unjustified in light of the arguments provided in this article.
We're starting a unique series on our company's blog - what we want to share and why? Our presentation at *R in Pharma 2020*
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