1. Get your Paycheck Protection Program funds
The Paycheck Protection Program (PPP) is a loan program that comes from the Coronavirus Aid, Relief, and Economic Security (CARES) Act and is backed by the United States Small Business Administration (SBA). It initially funded $350 billion dollars to subsidize bank loans to small businesses. These loans will be forgiven so long as the funds are used for payroll, rent, interest on mortgages, and utilities. The loan amount is up to 2.5 times your monthly payroll. Clearly, these are critical funds which can keep your site solvent during these lean times.
As of this writing, the program ran out of funds but will likely be reauthorized by the federal government, and many banks are accepting applications. If you haven’t already, contact your bank to see if they are accepting PPP applications, and get your submission in early. Since the funds are limited, it’s important to be one of the early ones to submit. For more information on the Payment Protection Program and to see if your site is eligible, visit the SBA’s website.
2. Create your COVID-19 related Clinical Trial Site SOPs
Update your written standard operating procedures to include any measures your site has implemented for COVID. Examples include: COVID pre-screening questionnaires for patients; sanitation procedures (for rooms, equipment, lab kits, IP kits, etc.); requirements for personal protective equipment; remote working; implementation of technologies for remote collaboration and access; enhanced IP management systems (such as home delivery, curb-site exchange); modification of patient travel (e.g, Uber/Lyft); or remote monitoring. Written documentation of your updated SOPs is especially useful to have when you make requests for additional site reimbursements (see next practice).
Need a place to start with your SOPs? Download these free SOP templates, specifically for research sites during COVID-19.
3. Re-Negotiate your Contracts to Get Additional Reimbursement In Your Clinical Trial Budgets
According to clinical trial attorney Edye Edens, sites should be renegotiating contracts with sponsors to get reimbursement for new procedures or measures implemented during COVID. As regulations from IRBs and the FDA have been updated and will continue to change, sites can argue that workflows need to be modified to remain in compliance.
Edens advises sites to follow this process: First, review your clinical trial agreement and budget for legal principles or language so you have a baseline understanding of your negotiating leverage. Second, identify the appropriate individual within the sponsor team, for whom you may need a referral. Third, send a clearly articulated, but respectful, ask, with a concise summary of all changes that you are seeking and a rationale for each.
CRIO has created a downloadable sample letter of justification that can be modified to match your research site’s requests.
Already, we’ve heard of success stories from sites who have used this approach. We’ll report back on our blog with lessons learned from our clients.
For more advice on how to initiate the conversation on site reimbursement with your sponsors, watch our webinar with Edye Edens.
4. Boost Your Clinical Trial Patient Recruitment Now By Building Pre-Screening Lists
Take advantage of this time to not only maintain, but expand your patient database. According to Matt Clair of Precision Recruitment, the current stay-at-home mandates mean that sites can reach patients at unprecedentedly high phone contact rates. Given the current unemployment rate, experts predict that more people will express interest in clinical research as it can provide much needed care for those who have lost insurance and also serve as an additional source of income. Patients will likely refer friends and family members for ongoing or upcoming studies as well.
By communicating with and advertising to potential patient participants now, your site can build your enrollment waitlists. When sponsors initiate studies and enrollment holds are lifted, you can quickly ramp up your enrollment and get busy again.
5. Keep your business development pipeline alive
The clinical research ecosystem has changed dramatically, but it is important that your site continues to identify new business opportunities and avenues of revenue. Use this time to reaffirm your site’s capabilities, and the steps you are taking to conduct research in this environment, to your sponsors and CRO’s. Business development expert Rachel Truxall revealed that even in recent weeks, several sponsors have continued to award sites with new studies.
Additionally, make sure your business development agent is on the lookout for studies that will need add-on sites, as well as the COVID-19 treatment and vaccine trials that will come down the pike shortly.
6. Go Electronic with Clinical Trial Software!
Adopt a technology platform, such as Clinical Research IO (CRIO), that offers eSource, CTMS (finance, recruiting, scheduling) and eRegulatory capabilities to keep your ongoing clinical research trials moving forward during and after the COVID crisis. Licensing this kind of technology will not only help eliminate paper processes and manual activities at your site, but increase efficiency, improve data quality, prevent data errors and allow for more investigator and sponsor oversight. Critically, with this technology, your site director, investigators, coordinators and other site personnel can all be productive while working from home, and your CRAs can perform remote monitoring.
As a company, we have seen an unprecedented surge in interest from sponsors and sites alike; in fact many sponsors are reimbursing sites for the cost of these systems in recognition of the benefits they provide them. We recommend sponsors reimburse sites $2,000 for eSource and $1,000 for eRegulatory software.
If you would like to learn more about our industry-leading electronic Source and eRegulatory software for sites, schedule a personalized demo here!