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Polaris Compliance Consultants, Inc.
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QA and Compliance Providers
QA and Compliance Providers

7 followers
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Our Social Media Manager Laurie Meehan got some nice press this week. +ClinOpsToolkit  interviewed Laurie earlier this summer, and the result is this article about how social media professionals in your company or your network can help you do your job and how you can get started yourself.  Thank you Lynn Mercer and +Nadia Bracken  for letting Polaris help spread this important message.  http://bit.ly/OtClnTK
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Did you know there are 5 guidances about complying with FDA's Risk Evaluation and Mitigation Strategy (REMS)? Via +ClinSmart
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FDA requires that systems be validated, and that's a problem for Artificial Intelligence in biopharma. As an AI system learns, it evolves new decision pathways, so the algorithms become increasingly unknown to the developers. And how do you test an AI system when its output will continually change? There are other interesting challenges as well, and they’re not all technical…
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Waiting for the EU Clinical Trial Regulation (CTR 536/2014) to become effective? Completing the common submission portal is a precondition for implementation, and that won't happen for a while. A 7th pre-production release is scheduled for early 2019 when it will be auditied and further plans communicated.
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FDA is holding an open meeting this month to discuss exclusion criteria guidelines. Some oncologists feel – at least this one feels – that exclusion criteria are sometimes too restrictive and needlessly prevent potential participants from contributing to the research and possibly benefiting from the experimental treatment.
STAT
STAT
statnews.com
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Watson shows some serious success: Artificial Intelligence is leading to significantly better clinical trial enrollment and significantly faster screening. (Via +OutSourcing-Pharma)
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Why do regulators care so much about Delegation of Authority logs? Because they provide evidence that study tasks have been assigned only to staff members qualified to carry them out. By reviewing DoA logs, monitors can help their sites comply with the new ICH E6(R2) requirements for PI supervision and staff qualifications.
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So +Uber Health can now interface with Bracket’s Patient Engagement app. This will allow research participants to request rides for study-related travel. “This integration allows Sponsors to manage payments so patients don’t have the upfront costs and can allow sponsors to restrict rides to study site locations to reduce risk.” via +OutSourcing-Pharma
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There’s a big difference between data records (think: verifiable information stored in a database or spreadsheet) and data signals (think: individual events that comprise trending topics). “It turns out that the immune system, for example, is basically a signals-based machine learning algorithm for detecting and dealing with antigens.” That’s why our immune system can suddenly go haywire and “turn against us” – it misreads “what’s trending”.

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A new +PwC paper discusses how the pharmaceutical industry has fared under the first year of the new administration and where it’s going. Lots of great graphics.
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