Negotiating clinical trial agreements successfully with sponsors and CROs can be fraught with challenges. Research institution’s administrative efforts are extensive and complex – there are myriad factors to take into consideration. It’s imperative for all parties to have a clear understanding of what’s being addressed. According to the National Institutes of Health, “Good contracts help ensure the sustainability of a site and guide how research will be conducted at the site. A contract should include both basic and high-level issues, including protection of patient confidentiality, intellectual property rights, and reimbursement provisions.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2835476/).
In many instances, one research staff member, generally the PI (Principal Investigator) is tasked with shepherding the contracting process, serving as the single point of contact for all parties. This necessary responsibility takes time away from focusing on providing exceptional patient care and good quality data. What if there was a better way to approach this necessary, complicated and time-sensitive process?
One method is to engage the services of a third-party fiscal agent that is solely responsible for negotiating budgets, contracts and finance management on behalf of clinical research institutions. The universe of items to be negotiated, according to hoganlovells.com (https://www.hoganlovells.com/~/media/hogan-lovells/pdf/publication/rad2006septoctclinicaltrials_pdf.pdf) includes:
- Regulatory compliance
- Confidentiality
- Publication
- Intellectual property and study data
- Indemnification
- Subject injury
- Insurance
- Payment
- Third-party reimbursement
- Termination rights
- Limitations of liability
- Independent contractors
The most skilled financial teams review budgets in meticulous detail, line by line, to negotiate transparently.
BTC Network takes a granular approach to budget negotiation, through analyzing the protocol to account for all possible overhead, resulting in an average of 30% to 40% increase. Innovative management of pass-through fees further augments clinical trial budgets. Additionally, we have buying power based on negotiating multiple site budgets across the same protocol. Lastly, our clinical experience and strong relationships with sponsors/CROs assists to promote your site’s growth and profitability. Learn more about how your site can benefit from our negotiation strength and other streamlined clinical trial services.
Further information on this topic is available. Contact a BTC Network Specialist at
857-284-7574, newtrials@btcsites.com, or https://btcsites.com/contact/
