ALCOA, GAMP, Part 11, GIGO, we cover it all.
(Sung to the tune of Simon and Garfunkel's "The Sound of Silence.")
Wednesday, December 9, 2015
The Sound of Compliance
Is data integrity music to your ears? Ours, too!
ALCOA, GAMP, Part 11, GIGO, we cover it all.
(Sung to the tune of Simon and Garfunkel's "The Sound of Silence.")
ALCOA, GAMP, Part 11, GIGO, we cover it all.
(Sung to the tune of Simon and Garfunkel's "The Sound of Silence.")
Tuesday, October 20, 2015
One Q & a Lotta A’s about SOPs for Research Sites
By Laurie Meehan
You know how it is with those LinkedIn discussion groups. You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved. So naturally, when I encountered the post above -- which had managed to attract 32 responses -- I was curious to see what had garnered such attention. (And yes, that was 3 months ago and I’m just getting around to writing about this now. Don’t judge me.)
Posted on LinkedIn in July:
“What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”
You know how it is with those LinkedIn discussion groups. You think you’re posting an intriguing and brilliantly conceived question that will inspire your colleagues to clear their desks, seize their keyboards, and plunge headlong into enthusiastic electronic debate. Instead, your post lands unceremoniously on the ground, with only the dullest of thuds, ignored and unloved. So naturally, when I encountered the post above -- which had managed to attract 32 responses -- I was curious to see what had garnered such attention. (And yes, that was 3 months ago and I’m just getting around to writing about this now. Don’t judge me.)
Tuesday, September 8, 2015
Big Changes for ICH GCP and EU Regulations
By Laurie Meehan
What GCP changes are being proposed for international clinical research?
How and when will they affect you?
How and when will they affect you?
What’s Changing?
Two things.
(1) The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).
(2) At about the same time the guidelines go into effect, new Clinical Trial Regulation (CTR) 563/2014 will replace the current, decade-old EU Directive 2001/20.
Monday, July 20, 2015
The CAPA Detective
Every industry has its detectives. Mechanics and journalists hunt for leaks. Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore. The level of intrigue may vary.
In the GMP world, it’s the CAPA investigator who serves as detective, identifying how and why manufacturing defects occur. The root cause is seldom obvious or sensational, but usually a confluence of seemingly innocuous deviations that can compromise an otherwise high-quality manufacturing process. That’s not terribly flashy, so you probably won’t find “The CAPA Detective” in among the other crime dramas making their debut in this year’s primetime lineup.
Or maybe you will.
Tuesday, June 2, 2015
A Modern Risk-based Monitor
Investigator fawn on her. Coordinators call on her.
She is the very Model of a Modern Risk-based Monitor.
With a little help from Gilbert & Sullivan, Polaris describes the quintessential Risk-based Monitor.
(Sung to the tune of "I Am the Very Model of a Modern Major General.")
Operetta notwithstanding, we've been closely watching the evolution of RBM in the industry and interacting with many of the significant players from sites, sponsors, CROs, and IT solution vendors.
If you Subscribe to our Newsletter this month, we'll send you a free compilation of our articles on RBM.
No singing.
She is the very Model of a Modern Risk-based Monitor.
With a little help from Gilbert & Sullivan, Polaris describes the quintessential Risk-based Monitor.
(Sung to the tune of "I Am the Very Model of a Modern Major General.")
Operetta notwithstanding, we've been closely watching the evolution of RBM in the industry and interacting with many of the significant players from sites, sponsors, CROs, and IT solution vendors.
If you Subscribe to our Newsletter this month, we'll send you a free compilation of our articles on RBM.
No singing.
Tuesday, April 21, 2015
Remote SDV/SDR: Alternatives to Redact/Fax
By Laurie Meehan
As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV). The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites. This happy outcome relies on the right combination of enabling technology, privacy/security policies, and source documentation procedures. At its most elegant, monitors can coordinate with the sites to receive (i) remote, (ii) temporary, and (iii) restricted access to their EMRs. All quality review of source documentation can be conducted off-site. Questions and queries about the source data can be also resolved remotely, sometimes by phone and sometimes using online meeting software like WebEx. With SDV/R complete, on-site monitors can focus on assessing other, more “presence-demanding” study elements, such as drug accountability and PI oversight.
As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV). The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites. This happy outcome relies on the right combination of enabling technology, privacy/security policies, and source documentation procedures. At its most elegant, monitors can coordinate with the sites to receive (i) remote, (ii) temporary, and (iii) restricted access to their EMRs. All quality review of source documentation can be conducted off-site. Questions and queries about the source data can be also resolved remotely, sometimes by phone and sometimes using online meeting software like WebEx. With SDV/R complete, on-site monitors can focus on assessing other, more “presence-demanding” study elements, such as drug accountability and PI oversight.
Tuesday, March 3, 2015
How to Tip Off a GCP Auditor in 25 Words or Less
By Laurie Meehan
“What tipped you off?” “How did you know to look there?”
When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.
The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel. Really. No kidding. Pinky swear. The audit findings, not surprisingly, are real too. I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations.
“What tipped you off?” “How did you know to look there?”
When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.
The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel. Really. No kidding. Pinky swear. The audit findings, not surprisingly, are real too. I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations.
Tuesday, January 27, 2015
Regulatory Tools Go UFO: Useful, Free & Online
By Laurie Meehan
Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations. Indeed, that’s why many people stay away. But if you can tolerate a little noise, I’ve found the fruitful far outweighs the fruitless. Case in point:
LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”
[I bet you wanna know what he’s talking about. Stay tuned.]
LinkedIn Member 2: “Don't you find it encouraging there are more and more online tools available to us?”
[Who is this sickening optimist?]
LinkedIn Member 1: “I do find it encouraging. What's the best way to keep up with all these new tools? Is there a web site keeping track of them?”
Ok, I’m LinkedIn Member 2, and the short answer to the question about tracking is "no". But I've been maintaining a laundry list of useful regulatory websites and online tools for myself, so thanks to this discussion, I scored my first blog topic for 2015. In no particular order, here are some of the tools/sites on my list. (The first in the list is the subject of the LinkedIn discussion above.)
Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations. Indeed, that’s why many people stay away. But if you can tolerate a little noise, I’ve found the fruitful far outweighs the fruitless. Case in point:
LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”
[I bet you wanna know what he’s talking about. Stay tuned.]
LinkedIn Member 2: “Don't you find it encouraging there are more and more online tools available to us?”
[Who is this sickening optimist?]
LinkedIn Member 1: “I do find it encouraging. What's the best way to keep up with all these new tools? Is there a web site keeping track of them?”
Ok, I’m LinkedIn Member 2, and the short answer to the question about tracking is "no". But I've been maintaining a laundry list of useful regulatory websites and online tools for myself, so thanks to this discussion, I scored my first blog topic for 2015. In no particular order, here are some of the tools/sites on my list. (The first in the list is the subject of the LinkedIn discussion above.)
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