Clinical Research Billing for small to medium trial sites

A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run. 

To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.  

Kristi founded Clinical Research Billing in 2015 to help independent research sites manage their CTMS and generate cash flow through invoicing and collections. After nearly seven years, she and her partners have built Clinical Research Billing into a successful, growing small business.

Kristi served as Chief Executive Officer of Atlantic Clinical Research Collaborative in Palm Beach County, Florida, where she oversaw the implementation of a clinical trial management system. 

Kristi is an experienced corporate executive with a background in corporate finance and international equity markets. 

Kristi received her M.B.A. in finance from The Wharton School at the University of Pennsylvania, B.A. in economics and psychology from Pitzer College, Claremont, California, and the Chartered Financial Analyst designation from the CFA Institute. 

She studied pharmaceutical law at Seton Hall University.

Please join me in welcoming Kristi on the show.

Kristi Etchberger on LinkedIn 

Sponsor:

This podcast is brought to you by Florence Healthcare. To learn more, visit https://florencehc.com/

Show Notes

[4:17] Managing finance for smaller sites boils down to these four things:

  1. Budget negotiation
  2. Using CTMS to track and invoice the expenses and work done 
  3. Collecting payments and finding out why invoices are unpaid 
  4.  How much revenue is coming in terms of visits done

[6:36] Benefits to clinical trial sites 

  1. Keeps them in business
  2. Keeps them recruiting 
  3. Keeps them hiring good people
  4. Be financially solvent 

[6:49] Budget negotiations are effective when:

  1. Sponsor sends a budget grid broken down by procedure costs. If Sponsor sends per patient amount, it needs to be broken down into Schedule of Events and Procedure Costs
  2. Site has a rate card with procedure costs, overhead, cost of principal investigator (PI) and research coordinator (RC) time 

[9:03] Attend conferences to discuss budget and fees with other research professionals. For example, sites should charge for not-for-cause audits as this is a big imposition on sites 

[11:18] Cost of procedure can vary across the country. CROs have done a good job of being flexible on those costs and allow regional differences in costs for procedures

[12:42] Are CROs making contract negotiations much more difficult for trial sites? 

[14:36] Role of CTMS in clinical research billing activities

  • Makes it easier for sites to track and bill for tests and procedures
  • Allows us to create reports for site owners, directors, PI
  • Makes it easier to pay PIs (doctors) for procedure, especially if multiple doctors are involved at a given site

[16:57] CTMS recommendations and how systems with e-source capabilities will have more advantages 

[18:10] Benefits of e-source capability in a CTMS

  1. Alleviates the disconnect between what the coordinator enters in EDC and what the coordinator enters in CTMS
  2. FDA is supporting e-source initiative and wants to see more 
  3. Makes is easy for research coordinators to collect patient data 
  4. Allows remote review by CRA and PI

[20:51] Optimizing CTMS to bill by procedure, allowing repeat test and procedures, manage billing for unscheduled visits, and more 

[23:35] Is it better for Sponsors/ CROs to pay sites automatically upon visit completion or should sites be responsible for sending invoices in order to get paid? 

  • Procedural reasons why visit payments are behind
  • 10-30% of the site revenue is billable. These funds can be utilized to hire another research coordinator, lab tech, or EDC person

[27:07] How to improve revenue and receivables for clinical trial sites 

  1. People need to look at financials each month 
  2. Look at the excel reports (instead of trying to locate the data in CTMS)
  3. Look at visit activity and not in terms of checks that arrived in the bank 
  4. Look at the most profitable coordinators, who is doing the most work and generating the most revenue for the site 

[31:32] When does it make sense for a site to hire a consultant or firm to help with clinical trial financials and systems?

  • Once you get over 10-20 studies you probably need help

[32:59] Difference between well established vs. less established sites in terms of financials 

  1. Sites that are growing get the extra 10-20% 
  2. Making sure they are getting paid
  3. Take care of their people (pay the best, appreciate their people) 
  4. Handle technology well 

[34:27] Workflow for managing clinical research billing 

  1. Build a detailed patient database in CTMS or use existing EMR. When you look at the feasibility questionnaire, you can look at your patient database
  2. Begin recruiting and leverage your patient database. Use advertising to bring more patient in 
  3. Track calls and text messages to potential patients
  4. Pay stipends through the systems ensures visit is getting entered immediately in CTMS
  5. Scheduling with doctors
  6. Tracking rooms where patient exams take place 

[38:04] Story of how Kristi’s team helped a site owner fix a major financial administration issue and helped bring in $200,000+ in about a month’s time

[40:15] You need to decide on a go-live data for your new system and turn off the old system

[42:48] Site directors need to care and look at the numbers (ex: looking at and managing revenue by study or revenue by coordinator). Engagement is important

[42:24] Differences between cash based vs. accrual based accounting

[46:54] Do not try to cut your low margin studies when you have high fixed costs 

[49:45] Role of IRB in clinical research site finances, particularly around patient stipends 

[51:07] Patient stipends are invoiceable. It may be best to have the sponsor pay patient stipends directly (vs. the site) and site does not need to fund it

  • Get sponsors to pay for patient stipends for unpaid screen failures

Resources Mentioned

Society of Clinical Research Sites (SCRS)

MAGI Clinical Research Conference 

Realtime CTMS
Clinical Conductor CTMS
CRIO CTMS 

Greenphire patient payment system

Medicare

Drug Information Association (DIA)

SCORA

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