Strategies for Maximizing Revenues in Clinical Research
Discover key strategies for optimizing revenues in clinical research, including understanding PSG expectations, negotiating fees, and considerations for non-PSG budgets. Learn about the importance of getting paid for your time, not just per subject fees, and how to effectively manage budgets for successful research outcomes.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Annual Meeting Coordinator Workshop 30Nov2023 Julia Spears, C.C.R.C. Chair, PSG Study Budget Committee
UNIFORM PER SUBJECT FEE PSG PSG Expectations Expectations In order to participate in PSG studies, all sites must accept the uniform Per Subject Fee (PSF) as decided in partnership by the sponsor and the PSG Study Budget Committee.
FEASIBILITY QUESTIONNAIRE (FQ) Draft budget included with protocol synopsis ONLY site overhead (Facilities and Administrative) cost is negotiable Ensure all necessary site / institutional staff have reviewed (and agreed to) the budget BEFORE responding to the FQ as willing to participate PSG PSG Expectations Expectations Confirm IRB fees Confirm Pharmacy fees Study Start-Up Fee includes, but is not limited to: CDA, FQ, contract negotiation, regulatory document preparation, etc. Provide site justification documents for all site fees that are mandatory
Taking one for THE TEAM Benefits of being part of the PSG: The largest and most experienced network of committed & credentialed PD Centers comprised of over 400 Credentialed Investigators and Coordinators at 156 sites Exclusive access to sponsored studies contracted with the PSG Site Support Coordinator assistance through the Coordinator Task Force Visiting Mentorship Program Information regarding Telemedicine, funding, regulatory documentation, and study start-up
Non-PSG Budget Considerations PROTOCOL COMPLEXITY # of visits # of distinct procedures / total quantity of procedures Procedures per visit Cost per visit Duration of follow up Enrollment / Screen fail rate Number of primary / secondary endpoints Multiple vendors
Get Paid for Your Time not just Per Subject Fees Add data entry and query management to your PSF fees For studies with a known high screen fail rate, negotiate one subject paid in full at time of site initiation Include a separate administrative fee for EACH submission to the IRB for amendments, ICF revisions, IND/SAE reports Charge an hourly rate per person, with a 30-minute minimum, for all mandatory teleconferences or webinars Require payment for all site monitoring and sponsor visits Expect payment for all site staff training: vendors, systems, raters Include contract language for option of change orders for issues discovered after initial negotiation
EQUITABLE PAYMENT TERMS EQUITABLE PAYMENT TERMS Develop payment terms: Quarterly with 0% retainage OR Monthly with negotiated percentage withheld Assess interest on withholding Set firm cap for amount held back Charge for invoicing payments (vs. automatic payments) and for pass- through costs (such as IRB fees) Require late fee or interest on overdue receivables Build multi-year studies with an annual cost increase
