Tuesday, December 6, 2016

When is a Customer NOT a Customer?

While patients are consumers of healthcare services, they can’t be considered customers in the traditional sense. The same is true of students. Over many years of teaching, I’ve noticed this parallel between the healthcare and education professions; both require significantly more “customer participation” to achieve desired outcomes than other industries do. That’s one reason it’s difficult to measure the quality of these institutions and the skills of their practitioners. That’s also why both industries focus so intently on engaging our communities; we simply can’t be successful unless we do.

Math Confusion
“Can You Hear Me Now?”
As the old joke goes, there are 3 types of people in this world: those who are good at math and those who aren’t. Many students believe themselves to be permanent denizens of the 2nd camp. They find mathematical concepts confusing and the terminology inscrutable, so they tend not to ask questions. They’re afraid they’re being judged, so they’re not always truthful. Tests and exams fill them with anxiety, and sometimes even panic (no doubt waking to nightmares of trains leaving stations at varying rates of speed). These are the students who need my help the most. Our success in overcoming these challenges together will depend heavily on the student/teacher connection we can establish, yet few students are actually able to choose the teacher with whom they are asked to connect. Sound like healthcare yet?

Tuesday, October 11, 2016

Avoiding Protocol Deviations

Year in and year out, protocol deviations are the most common FDA Site Inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this finding also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.

Why does this keep happening?

Tuesday, September 6, 2016

Optimizing Outsourcing Options for Small Sponsors

Question Mark
What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.

Tuesday, August 2, 2016

FDA Site Inspections: 5 Tips for Success

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.

Tuesday, June 14, 2016

More Than a Warehouse to Me

Impossible to write a love song about FDA warehousing regulations, you say?
Challenge accepted.

(Sung to the tune of Billy Joel's "She's Always A Woman.")

Tuesday, April 26, 2016

Movie Quotes for QA Professionals

What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.

In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes.  Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues.  Such a great idea was just asking to be stolen.  And who are we to resist the siren call of piracy?  So here’s our best attempt at making #QAmovieQuotes go viral.*

Don Corleone

“I’m gonna schedule an audit… he can’t refuse.”
       - Vendor Oversight Manager at Corleone Clinical


“Batches?  We don’t need to see no stinking batches!”
     - Said no GMP auditor ever.


Auditee: “You want candor?”
 Auditor:” I want the proof.”    
             Auditee: “You can’t access the proof!”
     (Not even A Few Good Men can view electronic source documents at some sites.)


"Contemporaneous.  You keep using that word.
I do not think it means what you think it means."
     - Inigo Montoya, CCRP

Blanche Dubois

“I’ve always depended on the kindness of trainers.”
     Oh no.  Who let Blanche talk to the Inspectors?

Wite Out

“I love the smell of Wite-Out in the morning.”
    - Compliance Auditor, Fraud Division


“Get busy complyin’ or get busy tryin’.”
     (Motivational poster at Shawshank Consulting)

Alladdin Chocolates

“Fecal transplants happen.”          
                    “Audits are like a box of chocolates…” 


 “That’s all right.  He can call me ‘Sour’ if he wants to.  I don’t mind.”
      Not every audit is like a trip to Magic Kingdom.

Doune Castle

                       Jr.  Auditor:  “How do you know it’s a glitch?”
 Sr. Auditor:  “It looks like one.”
    It’s not witchcraft; it’s experience – the holy grail of the QA industry.


“Of all the org charts in all the sites in all the world, you had to look into mine.”
     Qualification records are amiss at Casablanca Research Institute.
And amiss is still amiss.
     [Again, sorry.]

Cool Hand Luke

 “What we’ve got here is a failure to refrigerate”
     Dr. Luke’s Hand might be Cool, but his Investigational Product isn’t.
     (Is the study drug supposed to be the Color of Money?)

…And because the rhymes were just too good, we couldn’t resist…

Newman dressing

“What we’ve got here is a failure to investigate.”
“What we’ve got here is a failure to remediate.”
    CAPA fail, Newman Style

If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time.  Please share your humor!  (Fair warning – we took all the good ones.)

By Laurie Meehan

* Thanks to Robyn Barnes of MasterControl for this fun idea.

Photo credits

Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain

Tuesday, March 22, 2016

SOP Revision, SWAT-Style

By Laurie Meehan

SOP revision. It falls somewhere between income tax prep and colonoscopy prep on the likability scale.  So why would you want to read about it?  Maybe you’re hoping someone’s figured out a way to make the process more efficient and less painful.  Maybe we have.

SOP Binders
The SWAT Technique

Last month, we worked with a company to revise a set of SOPs using a technique we call SWAT.  (Any edgy appeal that name might have otherwise had will be immediately dulled by its acronym expansion: “SOP Working Analysis Team.”  It’s the best we could do.  Don’t judge.)

The goal of the SWAT technique is to revise the most documents in the least time, while preserving friendships, sobriety, and original hair color.  The heart of SWAT is an immersive, multi-day working session in which participants discuss SOP revisions and incorporate them in real time.  Careful planning, thorough preparation, and commitment from management and participants are keys to keeping the SWAT session productive.

It’s Not For Everyone

Up front, we need to say that SWAT won’t work for every organization.  While the size of the company may not be important, the size of the working team needs to be fairly small.  Also SWAT won’t work for every set of SOPs.  The documents need to be part of a natural grouping – a set of similar procedures – and not a random collection.

But in the right situations, SWAT works very well.  Last month, we conducted a 2-day SWAT session with a client’s QA department to revise a set of 10 auditing SOPs.  We’ve also successfully used the technique with ClinOps teams, for example, to revise sets of monitoring SOPs.

SWAT Planning and Preparation

The SWAT process begins with central planning.  A coordination team selects a logical grouping of SOPs to revise, and assembles a list of specific revisions to be made.  Where it’s not possible to provide specific revisions, instructions and guidelines are developed, such as “remove audit report distribution details” or “update to reflect new file safeguarding practices.”

Each SWAT participant is assigned an SOP from the revision set.  The participant doesn’t need to be the author of record, but must be knowledgeable enough to “represent” the SOP – to learn the document well and understand how it’s similar to the other SOPs in the revision set and in what ways it’s unique.  Based on this understanding, prior to the SWAT session, participants make applicable revisions to their individual documents using the information received from the coordination team.  Participants should also note questions and any open issues appropriate for SWAT discussion using inline comments. 

SWAT Session
SOP Cafe

The result of the SWAT session is a set of approval-ready SOPs.  The precise structure of the SWAT session to get you there depends on a variety of factors, such as how similar or dissimilar the SOPs are, the extent and complexity of the revisions, and whether subject matter expertise is concentrated or distributed among the group.  But all successful SWAT sessions we’ve conducted share these attributes:

  • Duration of 2 to 3 days.  Just long enough to accomplish the aggressive goal, just short enough to keep everyone from diving out the window.
  • Real-time revision.  The “SOP of the hour” is projected on a screen while participants sit in front of PCs and update their assigned SOPs accordingly.
    Air Horn
  • Rigorous facilitation. It’s natural for discussions about company procedures to morph into other topics, such as business strategy or staffing requirements.  Discussion *will* get off topic.  When it does, the facilitator must act quickly to table it.  You can maintain a list of tangent topics on a flip chart, schedule a meeting to discuss the most pressing items, ring a cowbell, blow an air horn, or drop a quarter in the “Diversion Jar” and move on, but keep those conversations out of your SWAT session.  Save the war stories for dinner.
  • Commitment to the process.  Scheduling the session is one thing, but remaining dedicated to the session is an act of will. It’s so ridiculously easy for outside work to creep in.  Management and participants must be committed to carving out the time and keeping the barbarians at the gate.
  • Of course: Plenty of caffeine and yummy treats.

If you’ve ever worked on SOPs, you know there’s a big difference between done and almost done.  To help ensure you emerge from the SWAT session with the former, time must be allotted for participants to format, polish, and conduct a quality review.  If it’s possible to scare up some on-site administrative support, that could help expedite the process.

SWAT Benefits

When you look on your team’s Outlook calendar and see 3 entire days blocked out, it can seem like an awful lot of time devoted to SOP revision.  But SWAT really doesn’t take any longer than the usual process, it’s just more obvious.  Does SWAT take significantly *less* time?  Mmmm, not sure, but SWAT brings with it other benefits.

SWAT produces a more consistent set of SOPs.  Since every document is compared to every other, it’s easy to notice and correct incidental differences.

SWAT is a cross-training opportunity.  Participants enter SWAT knowing their own SOP very well.  They leave knowing the whole SOP revision set very well.

SWAT gets it done.  Auditors, how many times have you cited facilities for failure to revise their SOPs within the specified window?  It’s not because there’s a willful disregard for SOP procedures.  It’s because, in the real world of work, revising SOPs is seldom prioritized highly enough to get on anyone’s schedule until the end of the revision window encroaches or – oops – has passed.  But schedule a SWAT and they will come. (And because the effort is so visible and so obviously resource-intensive, no one wants to be the one to drop the ball.  Participants come prepared and the resulting documents are the better for it.)

SWAT is a lot more fun.  Revising SOPs on your own is really boring.  Revising them in immersive sessions with colleagues is significantly more enjoyable.  Gallows humor reigns supreme.  Copious amounts of chocolate are consumed.  Air horns are blown in celebration.  Friendships, sobriety, and hair color remain intact.  Participants live to write another day.

Photo Credit:  Tenaciousme CoffeeArt, under Creative Commons License

Tuesday, February 2, 2016

Study Sites: Too Many Vendors, Too Little Time

By Laurie Meehan
IWRS Error

“I can’t get the IWRS to assign a kit number.”

“My ECG reports take forever to come back from the Core Lab.”

“The eCRF won’t let me create a new subject.”

“This stupid machine is blinking an error code again.”

Sound familiar?  Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites.  Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before.  And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.