Who’s Talking?

I’m trying to understand the diminishing communication that is going on these days. I don’t mean the quantity of communication opportunities, but the reduction in ‘real’ communication. I see e-mails go unanswered and those promised phone calls never occur, all without an explanation. Even the common courtesy of acknowledging a response to an ‘urgent’ request seems to be hard to get. So, what’s up? I have talked with others, and I am not alone. Does this ring true with you too?

So, first let’s qualify — we are not talking about the unsolicited sales call/e-mail, but real existing professional relationships and team members. A common example is this: You get a request for information, a proposal, something IMPORTANT to the initiator, e.g. they started the conversation. I know I am obligated, or at least know it is important and courteous to respond, even if with an explanation of a push back to a later time. Something, anything, to let the other person know you ‘heard’ them. Then you send them the information as quickly as you can. Too often, what happens next? NOTHING!! No reply acknowledging the receipt, no responding to follow-up questions, no communication at all. This is what I just have a hard time understanding. The conversation is left ‘hanging’. There is really no excuse is there? Vint Cerf (one of the ‘fathers’ of the internet) said in a recent interview that there are 3 billion people with access to the internet but 4 billion have a smart phone… Is it really that difficult to hit ‘reply’?
What is getting in the way of common courtesy and professionalism? The consensus from my discussion with colleagues and friends about this comes down to ‘information overload’ and ‘problems prioritizing’. I understand, since work can get really BUSY and over scheduled. And then there are just so many e-mails that need to be reviewed. Really? Do you really have to engage with all of them, or are most of them just folks copying you on their conversation (maybe to cover their bases)?

There are REAL BENEFITS to engaging and following-through with our colleagues, clients, and vendors. Here are just a few:

1. You actually will learn something
2. You are helping someone
3. You build trust and loyalty
4. You get what you want, when you want it

So, I believe to identify the real conversations that require your engagement is critical, especially if you have initiated them. Flag them, task them with a timeline – use your technology to help prioritize. Next, it will be important to set the rules with your colleagues, clients, and vendors. How does one know if they have just been given information to keep ‘on file’, or if they need to critically review and possibly respond? I believe if someone needs to respond or review they should be in the ‘TO:’ line of the e-mail. Those who just need to keep a copy for reading when they have time, should be in the ‘CC:’ line of the e-mail.

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Super Monitor – Part Two

As we move into the newly defined world of Risk-Based Quality Management in Clinical Trials (FDA Guidance) a Monitor might think their skills are being tempered and possibly replaced with data reports geared to trigger a site visit because of increased safety events, missed subject visits, low enrollment, etc. Not so – as the number of physical site visits are cut back because efficiency and cost-effectiveness; the Monitor becomes the ever more important link in the study team chain.

The shifting of work from the Monitor to the study site continues at a rapid pace; multiple EDC systems for data entry, CTMS for study management, Central Randomization System (CRS), EHR, central laboratories and Monitor access to EHR via IT (network security), etc.

SM Part Two


The study Monitor becomes the go-to person for all of the above and is sometimes the one face to face Sponsor/CRO contact throughout the entire study period. So, let’s get back to the basics:

  1. Be the point person for the study protocol; if you don’t know the answer find out and relay back to the site; don’t just forward that person’s contact information – you need to know the answer too
  2. Communications – find out the best method for your coordinator whether it be a second email, a phone call or even texting and when the best times are to call; note down their typical at-the-work desk times
  3. Work closely together at study startup to understand the work flow process for the department, who does what tasks
  4. Ask for a tour of the department(s)/units involved, introduce yourself and find out how the patient flows through the hospital/clinic system
  5. Be aware of the site’s local community events, news, weather, etc., these are good conversation starters and help build relationships
  6. Find out what the allowable budget is for site treats like doughnuts and coffee, lunch, etc. Be aware that some institutions frown on this so check on the rules
  7. Come in with a friendly, let’s work together attitude and be patient, not all action items can be dealt with in single visit – life happens so take it in stride
  8. Don’t be judgmental and overly critical, use common sense and approach as learning experiences; most errors and deviations are innocent but work out a plan to address using CAPA principles
  9. Be aware of the atmosphere of the department when you visit, again common sense but subtle clues in body language, emotions might help you in adjusting the agenda for a more productive visit
  10. Volunteer to make copies (again, follow the rules), file all the new documents in the binders, ask what supplies or help they need, and follow-through promptly
  11. As you review the records jot down or flag items to discuss at the end of the visit as part of the de-briefing time; this is part of the study protocol reinforcement process
  12. Monitors make mistakes too, be appreciative of your ‘training’ and willingly correct errors
  13. Finally, be aware of the big picture; you may end up working with these people again so it is important to be a good ambassador for clinical research
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Introducing rED Cap Share Station

Following close on the heels of our newest tool for ePRO, BSI is excited to introduce the new ‘Share Station’ functionality to our rED Cap System.  While BSI already has ‘Secure-Link’ that allows transfer of confidential information like protocols, data sets, etc.; this allows rED Cap users access to an internal secure data/document sharing area for a particular study.  Users can access the Share Station to make a request for information, and to upload information to a single or multiple set of users.






Before an upload (see above), the Description can be updated for more information to appear in an e-mail notification.  Either everyone in the list of users given share permission, or selected users need to be chosen.  A file can be attached, or only a reply to go to the user(s) e-mail without having any attachment involved.

In this example, when saved and uploaded will result in a rED Cap user (Sally Jones) with a folder for sharing only, and a folder as the ‘owner’:



rED Cap was created at BSI in the local Tampa Bay area close to the University of South Florida, James A. Haley VAH and Moffitt Cancer Center.


Please contact BSI for more information.

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rED Cap ePRO

For BSI’s future and current customers that already enjoy affordable excellent service, and adaptability, we are taking the opportunity to reveal the newest rED Cap tools for ePRO (electronic patient reported outcomes) endpoints.

rED Cap was created at BSI in the local Tampa Bay area close to the University of South Florida, James A. Haley VAH and Moffitt Cancer Center.

 The New VAS (Visual Analog Scale)

 A tool that allows you to ‘draw’ a vertical line to cross the scale using either a mouse, stylus or finger depending on your device (think i-Pad, tablet, notepad).



The rED Cap VAS comes with a handy calibration tool so whichever device is being used the scale can be calibrated as often as your protocol or QA procedures dictate:



This fool-proof data capture method has built-in specifications that ensure a perfect patient response every time:



To prevent this:



So that you get this data point:



No doodling, x-marks the spot, happy/sad faces or check marks required!


Standardized Instruments

The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment.  The original SF-36 came out from the Medical Outcome Study, MOS, done by the RAND Corporation. Since then a group of researchers from the original study released a commercial version of SF-36 while the original SF-36 is available in public domain license free from RAND. (Wikipedia).

Now, standardized instruments like the SF-36 can be incorporated into rED Cap for ease of patient use on your choice of devices; please contact BSI for more information.

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ImageThe St. Petersburg, Florida police department recently posted that 83% of recent auto thefts were due to the keys being left in the ignition. Curious – why would people leave their keys in the car and practically ask someone to steal it? Haven’t we been drummed in the head our entire adult lives about locking up the car, hiding valuables away, installing anti-theft devices, etc?

Turns out these are crimes of opportunity.  In Greek Mythology KAIROS (or Caerus) wasTile the spirit of opportunity, the youngest divine son of Zeus. He was depicted as a youth with a long lock of hair hanging down from his forehead, which indicated that Opportunity could only be grasped as he approached.

This is how it goes – someone will wander nonchalantly around a gas station, quick-mart, post-office looking for a hurried person wanting to just dash in and drop/pick-up an item, maybe work with a partner.  The soon to-be victim thinks ‘lots of people coming and going, a safe place to leave the car running for a few minutes – I’m just going to be 2 minutes?’

You get the picture – when they come out the car is gone innocently driven away by our astute thief; a crime of opportunity. So they don’t pull it off every time, it maybe days, weeks and months but eventually their patience is rewarded when Kairos passes by.

Opportunity is a game of chance, a favorable set of circumstances but I’m pretty sure Kairos walks among us still for opportunity is at every corner, every turn of the page, everything we see, hear and think about.  Don’t settle for the ways things/processes are always done, grab onto that lock of hair and go change your world – one day, one project at a time; after all the spirit of Opportunity is timeless.

Posted in Clinical, Clinical Monitoring, CRA, EDC, Inside BSI Blog, Monitoring, rEDCap | Tagged , , , , , , , , | Comments Off on Opportunity

Adaptable Crocodile

After watching a Sir David Attenborough special on the crocodile this weekend my interest was piqued when he noted that generally, the crocodilian reptile has remained unchanged for 70 million years the reason – adaptability.


(Credit: iStockphoto/Clark Wheeler)

Apparently no other species has evolved to adapt as well to the ever-changing climate changes, food sources, fresh or saltwater, etc.  Imagine my surprise when reading about Denis Jourdanet’s (1815-1892) work on hypoxia at high altitudes – a similar highlighted story in today’s Science Daily connected to research conducted on alligators to see how dinosaurs (a close relative) evolved in earth’s then 12% oxygen atmosphere.  Another related click brought me to biodiesel research; apparently extracted oil from alligator fat can easily be converted into biodiesel similar to soybeans.  This project focused on the alligator meat industry disposing about 15 million pounds of alligator fat in landfills (American Chemical Society (2011, August 17) – Gator in your tank.  Not only would this free up valuable food crops but shift the dependency on oil; move on over Tiger! Image

Who would have thought that this slightly terrifying apex predator has survived the millennia – here at BioStat we only go back two decades, but we have adapted to our client’s needs in those years and continue to do so; it’s part of our culture.

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Looking Forward, Connecting Backwards

ImageAs Steve Jobs famously said at Stanford University in a 2005 commencement address, “You can’t connect the dots looking forward, you can only connect them looking backwards”, there is great value in reflection and dedicated evaluation of the road traveled to the present situation.

There is learning to be accomplished by taking the problem, challenge, or success and connecting the dots backwards to the beginning. There are insights to be gained by finding the decisions and paths taken at each step to end up at the present.  I believe some of these processes of lessons learned are personal and are best left to individual contemplation, but in business and our team work we would benefit from connecting backwards in order to understand the best path forward.

There will always be times where it seems we have ‘blind trust’ in the future; we take the ‘big leap’. In reality it is not ‘blind’, but we have evaluated what has come before, and have confidence in our ‘gut feelings’. Maybe it has not been verbalized, but we are aware of it anyway. We should be sharing these lessons within our teams, and listening to their critiques.

Too often clinical research can be a victim of not enough thoughtful reflection on those lessons learned. Good intentions overlook reality. We have all been there, wanting the easiest, speediest and least expensive process to work and succeed. We feel reluctant or ‘negative’ to tell our team or clients that what we have learned  might adversely affect their program. We need to overcome those inclinations to be ‘yes’ women/men. We need to collaborate, challenge ideas and bring our connecting of the dots from the past into the present and future.

So, let us get out our markers and start connecting those dots from our experiences on projects. I am sure there will be a unique picture in there somewhere!

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Super Monitor

Super Monitor Cartoon

So, you’re the new Monitor, new kid on the block, etc. – doesn’t matter if you’re a newbie to the CRA arena (think gladiator) or you got assigned to a new clinical site; you have incredible power! You can wield the sword of ALCOA and bring sites to their knees; at the very least they surrender the charter of CAPA, at the very worst their data is branded and they get thrown to the lions (think BIMO).

You speak the universal languages of GCP, GXP, ICH, HIPAA and FDA and wear an armor of morality and ethics with a shield that defends the rights of research subjects but the most important weapons?

Common Sense and its partner Intuition/Gut Instinct.

DescartesDescartes stated “everyone has enough common sense but that is not enough, there is a method that must be followed”; and that method(s) is still being debated today.  Merriam-Webster defines it as ‘sound and prudent judgment based on a simple perception of the situation or facts’. Researcher Gary Klein, PhD reveals that, in fact, 90 percent of the critical decisions we make is based on our intuition.

While pouring over progress notes, flowcharts, records, lab slips, photographs, images, etc., whether it is paper or electronic that nagging question is always in the back of your mind

  • Do I truly have enough evidence?
  • Could it be a cut and paste error (EMR)?
  • Do I take charting by exception (CBE) at face value?
  • Should I be finding every single matching digit for digit in the source and the CRF?
  • Or, a Monitor’s worst nightmare – is this a real patient?

Trust your inner voice. If you feel the tinniest bit uncomfortable, check it again – you’ll be glad you did.  When in the trenches you’ll be able to say with 100% confidence that the monitoring battle was won!

Have any good ‘war’ tips to share?

Susanne Panzera
Clinical & Quality Affairs

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Does your Service Provider Have Emotional Intelligence?

ImageI recently read an article in the Tampa Bay Business Journal where the CEO of Florida Hospital, Tampa was discussing the importance of customer satisfaction, and how doctors are becoming more ‘emotionally intelligent’.

Wikipedia defines Emotional Intelligence (EI) as: “The ability to identify, assess, and control emotions of oneself, of others, and of groups”.

I wondered how well we do as service providers and colleagues in the research community when it comes to EI.

I am glad that at BSI “WE GET IT!!”  We value and respect our client and colleague relationships. We even went so far as to create BSI Culture and Value Statements that are high in emotional intelligence. For example:

We Work Efficiently And Are Responsive To Questions Or Comments

Coming From External Or Internal Sources

 Not being responsive can hurt relationships and cause confusion and inefficiency. Breaking a connection today could negatively affect tomorrow.

  • Do you suffer from communication inaction (not answering phone or e-mails) from your service provider, colleagues, connections, clients or business partners?
  • Is your service provider or colleague aware of how their actions (or inactions) affect you? Do they value you, listen to your wants and needs, and are they able to identify with you?

Share your stories with us!

 Read more about BSI at www.biostatinc.com


Maureen Lyden, President & CEO

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Welcome to Our New Website

ImageWelcome to BSI’s new ‘Inside BSI’ blog post and our new website! It is our goal to use this blog to keep our current and future customers, and all our colleagues, informed of our activities as a company, and our lessons learned. We want to share about our efforts to continue to provide excellent service with affordability, and to post ideas about our industry and research in these very interesting times!

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