Polaris Compliance Consultants
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
Igor Stefanov

Question: What percent of studies in the US are run by the 10 biggest sponsors?

Answer: 7% 

Is that what you'd expect? Do any of the other 3Q2018 clinical trial statistics in this article surprise you?

Accreditation and Competency Standards

The past year has seen some significant progress in developing objective standards for clinical research Investigators, staff, and sites. In October, ACRP announced an initiative to develop competency standards for Principal Investigators. This follows the January release of its Core Competency Guidelines for Clinical Research Coordinators. ACRP hopes that these two guidances will, among other things, help address the “one and done” phenomenon by giving prospective PIs a clear understanding of what running a study will require of both themselves and their most critical staff members.

Lastly, ACRES has started testing its Site Accreditation process, and is on target to begin accrediting study site early next year.

When Researchers Must Call Their Shots
In 2000, regulations went into effect that required researchers to specify their primary outcomes in 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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Older Posts

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eSource Terminology Untangled

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Love at First Site: Early Signs of Strong PI Oversight

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