Managing a successful clinical research site entails maintaining a consistent, transparent payables process in tandem with building a strong relationship with your PI (Principal Investigator) and Sub-I (Sub Investigator). There are different avenues for compensating clinical trial medical professionals for their effort, expertise and oversight. The particular sponsor and medical indication often determine the ideal way to configure your site’s expenses and provide fair, timely payments to site staff. This is not just ethical – it’s good business. The International Journal of Academic Medicine explains that “Modern CTs (clinical trials) constitute a highly specialized professional niche that is ever-changing and evolving. Clinical trial units (CTUs) constantly face diverse challenges and competing priorities, including patient enrollment activities, high staff turnover, maintaining compliance with updated regulations and guidance, as well as ensuring that new standards of care and best practices are being implemented and followed.” (http://www.ijam-web.org/article.asp?issn=2455-5568;year=2016;volume=2;issue=2;spage=203;epage=216;aulast=Butryn). In the face of these challenges, it’s imperative to implement processes that drive your site’s profitability and watch the bottom line, whether you’re using a percentage or a flat rate.
Our recent webinar, “PI Payables: Balancing Your Expenses and Revenue So That It All Makes Sense” outlined:
- Setting up payment – procedures vs. percentages
- Determining what warrants a payable
- Increasing payables based on higher enrollment
- Tracking provider earnings – what is paid/owed
- Utilizing a CTMS to streamline and automate the process
Initial setup is the key to success when it comes to payments. Whether you’re paying your providers a flat rate or a percentage, maintaining consistencies is essential to overall budget building and monitoring fixed expenses. Design a contract that outlines the payment process, including the projected enrollment goal for the trial so that the provider is able to estimate potential earnings. Explain the payment process; is your site paying the provider’s earnings as part of standard payroll? Or, is the Sponsor the payor of record? Determine the number of providers needed for the specific trial and the cadence of payment (weekly, bi-weekly or quarterly). Take into account equipment needed including scales, imaging and other lab essentials. Outline your total payable for each visit as a starting rate, keeping in mind that the rates may fluctuate based on the medical indication.
To determine what warrants a payable, conduct a thorough protocol review. Many procedures can be delegated to site staff other than the PI or Sub-I. Identify how long each visit will take to complete to justify a flat rate or percentage to pay. Decide if you will provide additional compensation for pass-through items or over-enrollment in the trial.
Enrollment has always been a critical phase of the clinical trial process. The NIH (National Institute of Health) shares “The recognition of barriers to successful participant enrollment in clinical studies is not new—a study over 25 years ago found that one third of a cohort of 41 randomized clinical studies at the NIH recruited less than 75% of their planned enrollment goals…Studies that do not achieve planned enrollments are unable to support their intended scientific hypotheses, thus reducing their scientific relevance and the efficiency of the entire clinical research enterprise.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3203249/).
Know your enrollment goal and work with the Sponsor for the potential to over enroll. Communicate with your provider and make a plan for compensation. Consider an enrollment bonus for each subject over the enrollment goal to encourage your provider to engage with your recruitment team. The Sponsor/CRO will be impressed.
Use a CTMS (clinical trial management system) to track your expenses, visits and generate monthly and quarterly reports. Work closely with your accounting team to process payables in a timely manner. Meet with each provider monthly to review the previous month’s financials and earnings. Send monthly reports to show each provider’s activity and ensure proper reporting of revenues. This data is useful when the need to make a new hire arises. Implementing a CTMS also allows for easy forecasting of potential earnings and the overall streamlining of processes.
BTC Network drives your site’s profitability by focusing on astute financial management practices that are tailored to your research site. You can access the webinar recording here. To leverage BTC’s clinical site financial experience, speak with a specialist.
Contact a BTC Network Specialist at 857-284-7574,
newtrials@btcsites.com, or https://btcsites.com/contact/
