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Research Clinics: You’re Leaving Too Much Money On The Table!

by Jae Chung

Authored by: Dan Sfera

I just wrapped up an hour long interview with Ana Marquez for my clinical trial talk show, “The Clinical Trials Guru”.  What we discussed during that interview actually inspired me to delve deeper into the subject of research clinics and their handling of cash flow, invoicing, contract negotiations and the like.

As Ana mentioned in the interview, while we are all very privileged to be able to work in this exciting industry, at the end of the day clinical research is a business and should be treated as such. Unfortunately for many sites, they realize this a little too late and ultimately are forced to close the doors on their business. In fact, according to my chat with Ana, 58% of sites report to be in more debt this year than last, while other sites that were in operation a few years ago are no longer in business today. While this lack of attention towards the financial aspects of clinical trials may certainly be due to many research clinics being primarily run by clinicians or other clinically minded individuals who understandably focus first on clinical operations, ignoring your site’s cash flow and financial performance may put your company and all its stakeholders (patients included) at risk of losing what you’ve worked so hard to build.

Tips when negotiating the Contract and Budget

The first and most important financial-related activity you need to focus more on is the contract and budget negotiation. This is the event at which research clinics can make the biggest impacts to their financial well being. The key to successfully negotiating a lucrative contract is being able to clearly explain why your site requires anywhere from a 20-120% (yes that’s right!) increase in its budget. You may not be able to double your budget in all cases, but it has happened plenty of times from my experiences as well as those of others. Don’t allow the negotiator on the other end to compare your site to other clinics. If you are given such a statement, respond by telling them that you have no idea what other sites are getting, but this is in fact what the procedures will cost you. It is, of course, important to know what you are talking about here and make sure you do your homework on what these procedures will actually cost you (including overhead).

Don’t forget to invoice these items

Another way sites tend to lose money is to forget to invoice for certain items such as: transportation costs for bringing subjects to the clinic, meal reimbursement for subjects, time required for staff members to be retrained on protocol amendments, record storage fees, time required to re-consent subjects, time required to process, document, and report all SAE’s, and much more. Make sure you negotiate for these costs in the budget, and when it comes time to bill the sponsor for doing these activities, make sure that you actually remember to invoice them. Our video interview explains just how to go about invoicing for these and other often-forgotten activities that are necessary for conducting any study these days.

Get paid in a timely manner!

A third concept to gain a better understanding and mastery of is receiving study payments in a timely manner. You should strive for ensuring monthly payments from sponsors. Although some sponsors/CRO’s are really trying to push for quarterly payments, I along with my interviewee, Ana Marquez, feel it is critical that sites receive monthly payments in order to reduce cash flow anxiety. After all, we pay all of our bills on a monthly cycle, why should we wait 3 or even 4 months for a sponsor to pay us? Whenever possible, insist on a monthly pay schedule in your contract. I’ve heard some rumors that sponsors and CRO’s may even begin to have sites invoice for regular patient/study visits. If and when this happens, your site better be very knowledgeable and efficient in terms of getting these invoices processed and sent out to the sponsor for billing.

Closing Thoughts

It is important for research sites to understand how to accomplish and retain profitability in order to continue serving their communities, keeping their employees and support staff focused on actually conducting studies and not worried about whether their next paychecks will arrive. If we all can get better at negotiating budgets and maintaining profitability, then ultimately, we will all do a better job at conducting the actual clinical trials. I’d love to know what you guys think about this.  Email me anytime at dan@southcoastclinicaltrials.com

About South Coast Clinical Trials:

SCCT was founded in 2001 by Dr. Adonis Sfera, M.D. who has been serving the community in his general and geriatric pyschiatry private practice for more than 15 years, and who continues to do so at our principal trial site in Anaheim. Dr. Sfera created SCCT in hopes of aiding in the discovery of new and more effective treatments for the very challenging disorders and conditions he encountered daily in his practice. He has since assembled a team of highly experienced professionals to assist in bringing these promising treatments to the people who need them.

About Dan Sfera:

Dan Sfera, BS, MBA, is a regulatory and contract specialist, is responsible for business development and is the Anaheim Site Director. In addition, Mr. Sfera is the site liaison for the company and is in charge of obtaining new studies as well as handling all of the necessary study start-up activities for our multiple sites. Dan serves as the liaison between South Coast Clinical Trials and SCCT’s pharmaceutical sponsors or Contract Research Organizations, ensuring that each and every facet of the trials are in full compliance with the Food and Drug Administration and Institutional Review Boards.

To contact Dan, please Click Here.

Follow Dan’s blog: http://www.TheClinicalTrialsGuru.com

Image: Boaz Yiftach / FreeDigitalPhotos.net

{ 5 comments… read them below or add one }

Gayathri Arun November 9, 2011 at 3:54 am

Hey, this is Gayathri Arun,have been in this industry for 4 years.We have just began a multispeciality
Clinical Research Setup in Madurai,Tamil Nadu,India.This place is highly potential,with doctors interested in clinical research, but without the “actual Know how”.We have tried to pool them at a single
plase and started off.This place caters for the south of Tamil Nadu and the patient population is just over whelming.Having involve myself in Psychiatric,diabetic,oncology,orthopedic and neurology studies
it is heartining to see both the patients and sponsors getting benefited.
We would highly interested in getting in touch with SCCT

Yvonne Goldman November 9, 2011 at 4:57 am

Dear Dan,

I really enjoyed this article in chromosome. With drug developers becoming more agressive in using tools like GrantPlan and others to drive prices down in what they offer in their clinical trial agreements, it is becoming more and more difficult for sites to make a profit on these studies.

Are you interested in speaking on this topic at our conference in April? It is being held in Philadelphia. If yes, I can send you our brochure and other information . I look forward to possibly speaking with you soon

Sherry Reuter November 9, 2011 at 8:13 am

Dan,
Thank you for this excellent article on this important topic!
As you point out, all stakeholders in this industry share the goal of conducting clinical research, and if study sites can’t afford to do so on the budgets given to them, it will be problematic to sponsors and everyone else as well. Many think that study sites get rich from doing trials, but the vast majority do not and struggle to stay out of the red.
When I taught The Business of Clinical Research at George Washington University one semester, Dan Manak was an excellent Guest Lecturer who informed the students of what they should currently expect reimbursement for, and many of them had not even thought of doing so for most of the items.This is a great first step towards maximizing sites’ budgets.
At a conference where I spoke, most sites indicated that the payment schedule was indeed as important as the amount. These small businesses have to pay their bills and salary for staff on time, and they do not have the cash reserves to float the costs of expenses incurred for months awaiting payment for work they performed for the sponsors. Business practices in other industries include monthly payment, why should our industry expect to function differently? As you note, all stakeholders are businesses that have to pay bills.
We all have felt the higher costs for everything from paper products to electricity, so it is just common sense that study sites would be affected as well and that the same budgets from several years ago are no longer going to cover costs. An article “Medical groups rank cost of running a practice as No. 1 worry” (http://www.healthcarefinancenews.com/news/medical-groups-rank-cost-running-practice-no-1-worry) confirms the challenges it takes to run a medical facility; study sites need realistic and timely budgets to be able to participate in clinical research.

Dan Sfera November 9, 2011 at 4:21 pm

Thanks for the feedback guys!

Gayathri, email me anytime at dan@southcoastclinicaltrials.com would love to chat with you.

Yvonne, I would love to present but I have some ideas regarding that. Feel free to email the details to me at dan@southcoastclinicaltrials.com and I can share my thoughts.

Sherry, it sounds like you get it!

Sherry Reuter November 13, 2011 at 2:42 pm

Yeah, Dan,
I do get it, glad you do too!
Best regards,
Sherry

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