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Thursday, January 31, 2013

3 Simple Ways to Improve the Approach

I was invited to speak on a panel this week at the Outsourcing in Clinical Trials West Coast conference.  This was my second year in attendance and the conference was an excellent investment of my time with lots of great networking and informative sessions.  The topic for my panel was “Examining mistakes some vendors make when approaching new clients to build and strengthen outsourcing partnerships”.

For the blog, I thought it would be a fun exercise to summarize a few key points brought forth by my fellow panel members.  However, I will flip it around by adding my comments on how each of the take-aways apply to our roles as monitors when establishing relationships with new clinical trial sites.  I’d also love to have your perspective so please email me at or leave a comment below.

I - Do Your Homework

You don't have to be a total stalker,
but a little internet research will help.
Our panel agreed that vendors can do a better job of learning about our company background, structure, and culture before they approach.  Most companies have a website and a lot of this information is listed there in a Mission Statement, Pipeline overview, Investor Reports, Press Releases, etc.  Anyone can google a company for news within the past 12 months and get a good idea of what the current challenges to the business are. You can also search by sponsor at to read a lot of details about past and current trials including who to contact, who the investigators are, and basics of the trial design. With this information in hand, vendors can tailor their approach to only offer the services and products that are most likely to be of interest rather than going through the whole dog and pony show.

So as monitors, here are some of my ideas on how you can you better prepare for a first site visit or any other in-person meeting with your site personnel for the first time.  It goes without saying that you should already know all the ins and outs of your protocol, be able to speak intelligently about the drug program, Investigator’s brochure, study tools, and the sponsor before you meet with any site personnel.  So let’s focus instead, on what you can now easily discover about the site.  Well, presumably you have the CV of the Principal Investigator and some of the key study staff.  Figure out when they graduated and where they completed their residency.  See where they grew up. Read through all their experience, have you worked on similar studies? Have you visited their home state? Do you have anything in common with their background that you could possibly use as an ice-breaker in the introduction?  If they are published, locate titles or abstracts so you know where their research interests are.  Consider bringing along a relevant recent journal publication or news article that you can pass along.  Google their office or research center to see if they have a website so you can learn more about their practice or recruitment strategies.  Are they on facebook, twitter, or other social media sites?  Many doctors have been reviewed by their patients on yelp; this can be enlightening.  Ask around with other regional CRAs you know who have worked in that therapeutic area if they are familiar with this site or any of the employees.  Maybe your company has an investigator database and you can glean some further insights there?  Go on and see what other studies they have done (you may need the location name of the site rather then the PI name to get any results or you can use the map). Now you can ask about their specific experience in other trials and head off any of those same challenges in yours.

By the way, you don’t have to tell them how much research you did or hint around too much (since you might seem like a stalker) but if you do this homework beforehand, you are going to be more prepared for the meeting and better able to find common ground and guide the conversation, trust me.  Since you now know so much about your site, you can easily tailor your communications to their trial experience level so you can be engaging and helpful rather than patronizing, overwhelming, or boring.  You’ll have more meaningful dialogue and can probably learn a lot from them when you ask them for more details about their past experiences.  Finally, if you put in this time and energy to kickstart a relationship then you obviously respect and admire other people that you work with; that will not go unnoticed downstream.

II - Avoid the Cold Call
The dreaded cold-call sales pitch.
On the panel, we all explained that we are busy and our time for vendor selection is limited.  We have a very basic expectation that business development people will be sensitive to our time.  Now don’t get me wrong, I love free lunch, sticky pads, clickable pens, squishy stress balls, and laser pointers, as much as the next guy, but my time is valuable and if I meet with each and every vendor that calls me out of the blue, my performance at work would suffer because I would run out of time to fulfill my basic job responsibilities.  The sad reality for new vendors is that we’re just more likely to work with vendors and people that we have known and worked with before.  When I get a cold call and they say “Is now a good time to chat?”  If I say “No” that is not an invitation to rattle off 10 bullet points quickly before I put down the receiver.  I would rather they say, “no problem, I’ll send a capabilities overview via email and hopefully we can schedule some time to chat after that”.  There was consensus on the panel that conferences like ASCO, therapeutic area programs, DIA, ACRP, outsourcing, etc. are a much better forum for getting to know one another rather than the telephone.  We also rely heavily on referrals from our colleagues in the industry so please spend less time on cold calls and more time networking for introductions from your satisfied clients for new business.  If on the off-chance a vendor catches me on a cold call and I have 10 minutes to chat, I will ask very specific questions about capabilities and metrics used to track performance in similar previous trials and ask particulars about their relationships with other clients.  If you call me, I expect that you already know about my business as I work for a publically traded company.  Again, they called me so they need to be prepared and have done their homework (see point 1 again).  I am not just sitting by my phone all day hoping some random vendor will call me and then ask me to explain what my company is working on; the information is out there.

So you are a CRA assigned to a new site and you were told by your lead to make a site contact within 10 business days.  OK, so if you just call out of the blue will the coordinator be pleased to hear from you?  Most likely, no.  My recommended approach is to send an email introduction first.
“Hi, my name is NadiaBoBadia.  I am a CRA based in San Francisco and I’ve been informed that we will be working together on the trial.  I am really looking forward to visiting your site next month.  I’d love to call and introduce myself to you this week.  I’ll try you this Thursday at 10am EST.  I also have availability after 2pm and would be happy to phone you at that time or another time if it is more convenient, just let me know.  I am hoping we can chat for 10-15 minutes regarding next steps for working on this trial together."  
See what I did there?  I am 100% planning to call them; they can expect it and prepare for the call.  I also provided an alternative time so they know I understand that they have other priorities in their schedule.  The way I phrased it, no response nets a call at 10am.  If I said, “Should I call at 10 or 2?” and they did not respond I would have been stuck with a cold call.  One other benefit of this approach method is that if they are the wrong contact person, they typically write back immediately and let you know right away, which saves a lot of time playing tag.

During your first phone call be sure to ask what method of contact works best.  I personally LOVE talking on the phone and I always follow-up with an email summarizing the conversation for a contact report.  However, I do understand that exclusively email or even texting is preferred by some coordinators and I accommodate them.

III - Determine the Decision Makers
Who has the power of the purse strings?
When CROs, EDC providers, recruitment vendors, lab and imaging vendors, or any other type of outsourcing partner approach a new client, they should determine as early as possible who the decision makers are so they are pitching to the right person; get those people in the room during demos and discussions.  On the panel, we all agreed that it is important to navigate the layers within an organization to figure out who signs the contract at the end of the day.  Are there folks that need to be won over in legal and contracts in addition to clinical?  Many organizations have preferred provider relationships and master service agreements, which represent a barrier for new vendors coming in.  Most sponsor companies will require a quality assurance visit or a business assessment before inking a contract with a new vendor.  If the vendor can ask the right questions early in the process, they should be able to define expectations around the proposal process in regards to how long it takes and who needs to bless vendor selection and contracts.

As site monitors, we can also benefit by figuring out who is running the show.  It should come as no surprise that at many sites, the decision of who gets recruited for your trial (or whether your data is entered into EDC in a timely fashion) is often times up to the coordinator.  It really depends on the therapeutic area and how niche the disease state is, but for many studies, it is the coordinator who digs through the patient database and approaches prospective patients with the informed consent.  The manner in which the coordinator presents the trial will impact how appealing the study is to a patient and their caregivers.  You should test this assumption and find out if the key to your enrollment may in fact lay with your coordinator.  Just ask what process they used in the last trial to identify potential subjects.  Try chocolate – it helps.  Make sure the coordinator is behind your study and likes working with you.  The next step is to figure out how to motivate the people whose efforts will contribute to the study goals and milestones.

It never hurts to show up with chocolate.
Moving Forward
OK, and this is a little bit off topic, but what about follow-up after the approach? Whether your first meeting was the start of a beautiful relationship and butterflies/rainbows/lilies rose up around you or whether they slammed the door in your face and you were standing in the cold, you will hopefully be working together and want to grow the relationship.  Consider sending a handwritten thank you card or small gift.  Email a link to an article that might interest them or share a case study or industry tool or website (The Lead CRA blog?) that you have found helpful in a past study.  Stay on their radar without being intrusive and your relationship will grow stronger.   I’m enthusiastic about working on clinical trials and I love building new relationships.  I hope you found some of these tips useful and you can improve your approach when meeting new colleagues in this industry.  Share your perspective with me at or please comment here on the blog.

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Tuesday, January 8, 2013

Striving for Improved Investigator and Site Relationships

Last year I was invited to present at a conference in San Francisco; it was a wonderful experience. Here are this year's conference details.

5th annual Outsourcing in Clinical Trials West Coast

I was just organizing some files on my computer and came across the slidedeck, "Striving for improved Investigator and site relationships to achieve higher commitment and optimal patient numbers" that I created for my topic in 2012.  Since I never got around to sharing it with you all last year (except for those of you that provided notes and edits - thanks again!!!), please enjoy and let me know if you have any comments or other feedback.  I'll post it in a few parts since it was a long thirty minute presentation.  Part I is below. Part II Part III


Intro: As a CRA and Clinical Program Manager I have obtained a mix of pharma & CRO experience. I have worked in all phases of clinical research, I-IV and I have additional experience in regional monitoring & in Clinical Data Management. I am the author of The Lead CRA blog.
In every study as sponsors, we need great relationships to meet our program goals.  It is critical to form an understanding of endpoints in order to obtain quality data.
I am also very interested in your views and would welcome your sharing some of your successes via email or the blog comments.

Investigators participate in clinical trials for a variety of reasons including scientific interest , professional credentialing, ļ¬nancial remuneration, and as a means to provide new therapeutic options in their clinical practice.
What else motivates investigators to work on trials?
the attributes of the study
the organization running the study
to increase patient base, recruit into their practice
opportunity to consult with experts

Determining the motivators for PI participation in your trial is essential to a good feasibility and site selection initiative. Sponsors must choose the right investigators and also understand how to motivate them.

Get commitment to the trial for better patient enrollment numbers.
Why do we want relationships with our sites?
incentivize them to prioritize our study
achieve timelines 
have quality data

Your priority must be to make the PI and study staff stakeholders.  Be strategic and focus on the future of your drug development program(s).  There is a huge incremental cost to recruit new investigators at each phase of development.  Work to attract and retain your investigators.  Even if they are one-time investigators, ultimately, they will be the people you will market to in the future to prescribe/buy/promote your drug products. Relationships matter.

Difficult conversations  are easier to have in the beginning of a study or mid-conduct rather than at the last visit before data lock, or when it is time to sign off on the casebook, or in the context of a sponsor or FDA audit.
Interact before the Investigator Meeting 
Get protocol input 
Avoid capturing the wrong information
Save $$$ by making tweaks before rollout
Are there other sites we should be approaching?
Can you help us develop recruitment and retention materials?
Ask site staff to review CRFs and CRF completion guidelines and edit checks 
Request that your Study Coordinators assist in developing global source documents. This will avoid duplicating information that is obtained in regular clinic chart and head off downstream frustration

Engage beyond the Investigator Meeting
Be present at industry & therapeutic area conferences
Perform ambassador work and actually visit sites
Host teleconferences – invite Study Coordinators to speak and share best practices
Bring Study Coordinators to a destination round-table
Have a face-to-face meeting or "Town Hall"
Institute brainstorming panels (operational feasibility, safety oversight, recruitment strategies)

The Difficult Conversations
When communicating with study site personnel do not allow gripe sessions.  Insist on solution-oriented discussion.  If they have criticisms then ask the question, "What can we do better?"  You should acknowledge that you heard the criticism.  To ensure understanding and alignment, you can re-state the problem or concern before addressing any objections.

Engage beyond the Investigator Meeting – this is face-to-face SC session done to boost enrollment mid-study; it was held in Vegas at the Four Seasons.
Whenever you interact with your investigators, make reputation management your primary agenda.
Who are we?
How are we to work with?
What do we stand for?

At the face-to-face session pictured above we learned a lot about this specific trial that was struggling to enroll.  After lots of discussion, it turned out most of the Screen Fails were because subjects were not interested in committing to the long/difficult protocol.  The Study Coordinators took turns role-playing with one-another to address participant objections and explain the purpose and objectives of the trial.  They also offered tips and suggestions that allowed our sponsor to create literature and recruitment tools.  The sponsor decided after the meeting to allow re-screening of Screen Failures and more than 10% of the original failures "not interested" were enrolled.  The exercise truly demonstrated that the study team has the greatest influence on a subject’s decision to participate.  This face-to-face meeting really provided a new kick-start to enrollment and brought us closer as a sponsor to the site personnel.

continued in... Part II Part III

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Improved Investigator and Site Relationships - Part II

This is a presentation I gave at the 4th annual Outsourcing in Clinical Trials conference in San Francisco in February of 2012. It has been posted in three parts:

Click here to go back and review Part I 
Read Part II below
Part III - conclusion


Support the sites in order to maximize subject enrollment of THE RIGHT PATIENTS, quickly. 
Consider having the study medical monitor or other scientific/medical officers from your company travel and outreach to sites.  Identify conferences where many of your important sites are attending and send a representative to discuss and promote the study.

Educate the sites in the following areas:

How is the sponsor credentialed?
What is our experience in this therapeutic area
Who are our advisors (if well-known)
What other sites are we working with

Present Evidence 
• Demonstrated safety and efficacy
• Why are we doing this? 
• Explain issues in the Investigator Brochure (explain for clinicians technically and for non-clinicians in lay terms)

Why should PI share the resources and risk?
• What problem solved?
• How is this superior than other available therapies?
• Focus on objectives and endpoints of the trial

Translate protocol decisions

Explain reasoning behind inclusion and exclusion criteria
Defend design 
Explain sample size
Describe planned statistical analysis
How does this trial fit in the overall drug development program 

Communicate timelines
Share enrollment numbers 
Notify in advance of planned scientific advisory board meetings
Adequately notify data entry personnel of planned data cuts 
Are there planned interim posters and abstracts?

Remind study sites that even a study that fails to meet all endpoints is an important trial to your company.  Making go-no-go decisions on NDA candidates early is fiscally important.  The trial needs to be enrolled as soon as possible in order to finish as early as possible and permit analysis of the data.


Keep messaging tight, brief, and organized. Avoid complexity
What am I saying or adding with this? 
Before you put together a super verbose newsletter or another unnecessary blast fax, apply cuts and edits.  Make sure that every message is useful and comprehensive; balance the need to include all of the necessary information so you won't have to clarify later and there won't be ambiguity.

Same message, different method
Consider targeted messaging, some sites need different types of support depending on their experience and performance. 

Avoid “machine-gun” approach and make sure messaging is timely, appropriate, and not overwhelming.
Communicate with respect
Monitor to ensure that your interactions are not unwelcome.  In an effort to "keep in touch" with your sites you must treat carefully as to not barrage them.  Be wary of any investigative site that might have resent for your company's involvement.  The study site personnel do tend to interact across sites and you must always keep your reputation squeaky clean.  Also monitor for negative responses to avoid damage to the reputation you are working to build.

Avoid band-aid approach
Allow for different messaging methods for different sites and be willing to tailor messages.

Continue on to... Part III - conclusion

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Investigator and Site Relationships - Part III

This is the third and final portion of a presentation I delivered at a conference in February 2012 entitled: "Striving for improved Investigator and site relationships to achieve higher commitment and optimal patient numbers"

Click here to go back and review Part I 
Click here for a link back to Part II
Read Part III - conclusion below


Thank your investigative sites often and genuinely. 
What are they doing right?
Great care and consideration went in to choosing these sites. Surely you can think of something they are doing well and praise them for it.  It is very important to recognize effort and address issues in a timely fashion.  If the site is inexperienced or very busy, they might benefit from a Study Coordinator buddy program.  This engages the problem site but also recognizes the helper site as a "model" site; it is a benefit to both sites.

Give 'em Goodies
Some tools and forms of recognition are free or low-cost.  Here are examples from other studies I have used.
  • MD to MD brochures
  • In-service slidedecks for training within their practice
  • CRF revision guides
  • Mini-protocols
  • Newsletters
  • pocket inc/exc cards
  • dose modification and calculation cards 
  • Visit window calculators/wheels
  • Laminated diagrams and figures

Pay them on time
Like you, the study sites are running a business and they have monthly expenses to cover; don't delay to pay.  By providing timely reimbursements you demonstrate respect, fulfill your contractual obligations, and increase the likelihood that sites will work harder for you in this study and the next when.  When the sites achieve their goals you should pay them.

Doing small, minimally time-consuming tasks will have a site jump through hoops for you…
How can you help them reach their goals? 
Think about all the administrative items that are involved in terms of recruitment, enrollment, data entry/query resolution, and monitoring completion.  My team and I have come up with lots of little time-savers to help our sites along the way. Sometimes it is as simple as a pre-printed FedEx label, making some copies, or sending an empty 3-ring binder they can used to stay organized.  If there are forms or documents that are routinely filled out by all sites, have the monitors assist or provide example completed forms as you know the forms well and will be more familiar. 

I love telling the story of a site that my team was brought in to rescue. They were behind by 6 months in data entry because 10 surgical charts had not been obtained from the hospital.  We paid for the copies and sent a courier to pick up those charts (pictured above).  The Study Coordinator had just been putting it off since it was an unpleasant task.  We brought in lunch several days, trained her on the EDC system, assisted in flagging adverse events, helped her organize her subject binders, and sat with her as she worked through the auto-queries.  It was a long but productive week and she was so grateful and quick to resolve all queries from that point forward because we had helped her catch up.

Ensure monitors have a deep knowledge of the protocol and any amendments. 
This slide could really be a presentation topic in itself, but you must ensure monitors have protocol fluency.   

Make sure monitors know which deviations adversely affect endpoint and how to report and re-train staff.  If  a subject finishes the trial but is not evaluable, you have wasted a randomization slot, you might not be able to power your study, and you have needlessly paid for monitoring and conduct and learned very little about your drug product.

If you can incentivize your monitors to help study coordinator's during their visits and reduce administrative burden rather than nit-picking them, your sites will perform better.  It is a monitors' responsibility to be a partner, not an adversary or a hall monitor.  It is your responsibility to remind them on this charge.  They are the face of your company in this trial and your reputation rests with them. 

Be flexible to review and adjust messaging in your study.
The bottom line is that good relationships matter.  Solid relationships are obtained through:
  1) listening
  2) supporting
  3) Training

Yes, you are in a rush to finish your study but don't let the shortsightedness of the endpoints prevent you from creating a lasting relationship that will endure throughout the entire drug development program.  Align the entire study team in this venture and obtain buy in from the top down so you can take the necessary time before, during, and after the study to reach out to investigative sites with the best support and recognition possible.  Best wishes for deep relationships and quality data.

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