|Santa Claus Gets a Warning Letter
Polaris Compliance Consultants
Oh no! FDA found egregious CGMP violations when it inspected *Santa’s Workshop LLC* earlier this year, citing training deficiencies for its Enterprise Labor Force (ELF) team, as well as violations in its warehousing, distribution, and quality control operations. Read the Warning Letter here.
(Happy Holidays, everyone.)
1400 People Can't be Wrong
Polaris Compliance Consultants, Complion
Polaris Compliance Consultants was delighted to present Complion’s October webinar, “What ICH E6(R2) Really Means for Research Sites!” 1400 people registered for the live event, which speaks to the interest in the topic. If you missed the live presentation, you can still watch the recorded version that Complion made available to the public, free of charge. Far more questions were submitted during the webinar than we could address during the Q&A period, so we've answered them for you in this post. It was interesting to see that many of the questions related to documentation and document retention. These issues can be confusing for study sites, so we hope you find our responses helpful.
US Clinical Trial Snapshot
Question: What percent of studies in the US are run by the 10 biggest sponsors?
Is that what you'd expect? Do any of the other 3Q2018 clinical trial statistics in this article surprise you?
Accreditation and Competency Standards
When Researchers Must Call Their Shots
In 2000, regulations went into effect that required researchers to specify their primary outcomes in ClinicalTrials.gov. How have research results changed since researchers had to identify what they were looking for before the start of the study? You can read about the methodology behind the chart here.
Patients, Protocols, and Platforms
There have been a lot of articles about both the impact of social media on clinical research and the importance of listening to the patient perspective for study design, but few with as much heart as this.
Recommendations for Remote Trials
Clinical Trial Transformation Initiative (CTTI)
Whether you call them remote trials, virtual trials, siteless trials, direct-to-patient trials, or decentralized clinical trials (DCTs), research models that differ from the traditional site-oriented model impose common challenges. CTTI has developed a detailed set of recommendations to assist DCT researchers overcome those challenges. CTTI offers recommendations for protocol design, telemedicine licensing, supply chain management, delegation, oversight, and safety monitoring.
Polaris Compliance Consultants Corner
To all our readers, clients, and colleagues, we at Polaris extend our sincere wishes for a happy, healthy holiday season and a hopeful start to the new year.
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