Kelly Willenberg & Associates

Archive for the ‘Uncategorized’ Category

Shock Your Potential – Top 10 Tips for Surviving the Sudden Loss of a Spouse

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Go to my podcast page and listen to my interview with Michael Sherlock in her Shock Your Potential Series! Most of you know that I lost my husband in a hit and run cycling accident in June of 2017. These tips will help anyone who is dealing with the death of a spouse. #researchbeast

Weather the Storm

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Since the beginning of the Pandemic, we have realized how important community is. Connecting with people in new and healthy ways has become the norm. My social life was part of my travels prior to COVID and now I see that social networking changing in the future. My relationship with clients was a part of me. There were days when I felt as though I had made a difference in someone’s life as I traveled across the country. When a site launched a process my team was implementing, I cannot describe the overall exhilaration I experienced. For me, seeing a positive trajectory encouraged me to continue to help clients each and every day.

Then COVID hit. Living out of a suitcase on the road stopped. The relationships that I had face to face were no longer existent. Building that rapport via zoom is not always easy. I am grateful for the community of compliance people that surround me. Whether it’s the billing or compliance peeps, the HCCA colleagues across the country or the rookie that just needs help figuring out how to do a coverage analysis, I treasured those times. Now, our field is experiencing an enormous amount of change. We are having to figure out how to manage time while working remotely, how to train new staff when we are not able to be next to each other, or how to manage the quality of research care during isolation and restrictions.  We all are going to need to learn how to adjust to new ways of collaborating and practicing as research professionals as we move forward.

Relying on our peers with whom we can relate our burdens and challenges to is essential during this crazy time. Reach out to colleagues and lead the way when they feel insecure. Passionate words may matter if they are having a bad day. Encourage others to turn on their camera on zoom so you can have eye contact. Framing an effective message to others through a meeting on zoom can be problematic when they will not turn on their camera and you have no idea their body language or facial expression.

The landscape of research healthcare compliance will evolve in ways we cannot imagine yet. No matter what the future brings, my constant will always be a shared commitment to you to keep our relationship alive and adjust as needed. Stay well as we weather the storm.

Medical Documentation in Billing Compliance

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Good documentation related to medical necessity is your defense for billing compliance when you have a solid coverage analysis to back up how you intended to bill before your study started. When there is a review in billing routine costs in a qualifying trial, the medical documentation matching up with proper orders helps a tie everything together. Study coordinators can sometimes assist a physician to address documentation in the electronic medical records surrounding the clinical trial. Every piece of information can be utilized for the case report forms and the competency of the care when you have good documentation.

Utilizing your study calendar, coverage analysis or grid within a CTMS can help to describe events accurately and objectively. Documenting the consent process and assessments help with the overall review of a patient’s complete disease process. Describing in the patient’s own words or their understanding of the consent can also confirm the patient made a well-informed decision about participation in the trial.

Consider how you document late entries or protocol deviations as well, as they can impact something on a study calendar. This information can sometimes be helpful when clarifying what actually occurred with the patient. Good documentation can be a coordinator and PI’s best defense when a claim is denied or reviewed. Document wisely!

When to Hire Help

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Batman had Robin. James Bond had Moneypenny and Q. Pat Sajak has Vanna White. Everyone needs someone that they can depend on. Sometimes we have clients that use us on an “ad hoc” basis. They put us on contract, then when the going gets tough, they call upon us. This comes in handy if you get backed up in coverage analysis, budget negotiations, or IRB regulatory submissions. We sometimes find ourselves with mounds of work when we least expect it.

So, when do you ask for help? Perhaps it is when you or your team realizes that you are overwhelmed. Maybe you recognize a redundancy that a person with more expertise can help, i.e. a coverage analysis. Do not wait until you are at the breaking point but rather be ready before the extreme need occurs. How do you figure out if hiring help is NOW? First, do you find yourself repeating tasks or redoing others work that keep you from doing your job well? Have you lost time investing in a new process that now you are not even sure the process is effective? Will you save time and money if your freeing up time within your team’s workload?

Asking for help can be the difference between your research team being successful or being spaced out and not effective. Having someone hired to help you or your team can expand your network. It can get you out of a bad situation, help find solutions to ongoing problems and bring in a fresh perspective on how to approach your business model.


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Given where we are within the quarantine and self-isolation with the pandemic, many of our colleagues are working from home, been furloughed, or even lost their job. In a recent Research Perch, I discussed being cognizant of how your research or compliance team may be feeling right now. With the ongoing issues of how sites are doing research, it does not amaze me what I hear from sites.

The S in SNAFU is the skepticism and sadness that people feel with current situation. Sites have new studies on hold and people are not working. Some people are skeptic about what is occurring and there is sadness that we may never get back to where we were. The N stands for being nervous about the future of clinical research. Where are we headed? One client told me she was having nightmares about the future. Little do we know about what is going to happen as we are in some uncharted territory at present. The A is the apprehension and anxiousness all of us are experiencing now. What is coming next is something I have heard from sites? As we work through the next few months, anxiousness may linger. The F in SNAFU is the utter frustration that people have while working at home. Some are not only working at home, but they are having to teach multiple age children, share computers, cook dinner and keep every one in the household safe. Children are fearful and parents are seeing that in acting out and sleep patterns being interrupted. The U boils down to the uncertainty in what is going to happen until a vaccine, treatment or better tracing occurs. When will we be able to travel safely again? The unease that people feel is real!

Consider all of this in your team’s ability to do work at this point. Remember gratitude and try and put yourself in their shoes if they have young children at home during zoom meetings. Your influence and effort shape the next leader. To paraphrase Lin Manuel Miranda in the musical Hamilton, are seeds in a garden that will grow well into the future. Right now nobody knows what that future looks like so lead with finesse!