At ClinBiz we are honored and privileged to serve various clients in the industry and as a result have a wide view of the current trends around site contracts, budgets and payments. And as we love ‘connecting on the business aspects of clinical trials’, we thought we would share some of the current trends we have observed across multiple industry study sponsors on the topic of site contracts, budgets and payments. Some of the trends observed are what we would expect given the natural industry progression, some are surprising and some…let’s just say we still have room for improvement… Regardless, we hope the information contained here will be helpful and insightful for conversations within your organizations.
Site Contract Negotiations – Observed Trends
Greater Use of Master Agreements/Previously Negotiated Language
Although the use of master agreements and previously negotiated language have been around for a long time, it is great to see that most study sponsors are using these tools as the basic benchmark for site contract negotiations. Only a few years ago the use of master agreements and previously negotiated language was a novel and revolutionary concept presented at industry conferences to streamline site contract negotiations. This has now become the starting point for site contract (language) negotiations for many sponsors.
More Site Management Organizations (SMOs) Involved
This is a trend we are seeing more and more prevalent – the involvement of site management organizations (SMOs) in site contract and budget negotiations. It is good to be aware of this increasing trend of SMO involvement when having internal discussions and forming strategy for site contract and budget negotiations. The involvement of more SMOs in these negotiations come with slightly more complex contract language and different budget fees that need to be accounted for when planning.
Greater Focus on Calls for Issue Resolution
I know what you are thinking – “Calls for issue resolution? Really? I did not need to read an article for this”. I know, not a mind-blowing solution for site contract and budget negotiations but it is a very encouraging trend we are seeing with study sponsors similar to the use of master agreements and previously negotiated language as the benchmark and not an after thought. Most study sponsors are consistently having site contract and budget negotiators connect via a call with negotiators and clinical teams from the investigator/research site side if a negotiation point is not resolved within two or three email communications.
Site Budgets – Development and Negotiations
Streamlining Internal FMV and Escalation/Deviation Processes
We are seeing a growing trend with study sponsors reviewing, revising or in some cases establishing for the first time their fair market value (FMV) and escalation/deviation processes for site budget development and negotiations. Study sponsors are realizing that a robust and well-established FMV and escalation/deviation process is key to speeding up site budget negotiations while still protecting their organization (and all parties) from even the appearance of impropriety especially in the event of an audit or investigation. This is a growing trend even with study sponsors who outsource their site contract and budget negotiations to contract research organization (CRO). A flexible yet robust and well-documented FMV and escalation/deviation process is a growing trend.
Focus on Improved Site Relationships and Sustainability
Site Budget Customization Prior to Initial Contact
Similar to the use of previously negotiated language, more and more study sponsors are having site budgets customized with site-specific and previously negotiated items prior to sending these out to investigator sites when beginning negotiations. This trend is slowly becoming a benchmark in site budget development and negotiations world.
Approval of Additional Site Fees
Across study sponsors there is a growing trend in the approval of the following investigator site fees with most being study-specific:
Sponsor-required technology training, study-specific contract/budget negotiations and increased administrative burden due to protocol complexity
Approval of support for staffing needs
Approval of new fees for decentralized/virtual trials
Negotiating at Per Patient Amount Versus Per Visit Amount or Procedure Amount
We are seeing a growing and encouraging trend where more study sponsors are negotiating with investigator sites at the per patient amount of site budgets versus at the visit/procedure level. The reason this trend is encouraging is because many study sponsors’ FMV and escalation/deviation processes are built around where you are negotiating from (E.g. per patient amount, per visit amount, per procedure amount, etc.) and negotiating at the per patient amount provides a greater level of flexibility for negotiators before having to go through an FMV escalation/deviation process which can slow things down.
Patient Focus: Patient Recruitment and Reducing Patient/Caregiver Burden
Another encouraging upward trend we have observed across study sponsors is a greater and greater patient focus that is even reflected within site budget development and negotiations. One specific example of this growing trend is that additional patient recruitment fees are being approved (study-dependent) with more frequency. Another example includes approving fees within the site budget to further reduce patient and caregiver burden. Reducing patient burden has been receiving focus for a number of years but now we are also seeing study sponsors looking to reduce the caregiver burden for more and more non-pediatric studies.
Greater Interest and Adoption of Site Budget Technology
Perhaps one of the more encouraging yet surprising upward trends that we have been seeing is the greater interest and adoption of technology for site contract and budget negotiations given the historical slowness-to-adopt sentiment in the industry. This is encouraging and we’ll keep an eye on this trend.
Site Payments
More Adoption of Monthly Versus Quarterly Payments (USA)
I know, this is something investigator sites in the US have been asking for years and while there are a few study sponsors who are still living under a rock and paying sites quarterly (which we all know is really 6 months or more in site payment world language), it has been very encouraging to see more and more study sponsors adopt a monthly site payment schedule. The growing use of site payment technology seems to perhaps be playing a role in this. A few years ago this trend was only a mere hope for improving site relationships and sustainability. It is one of my favorite increasing trends to see on this topic.
Greater Adoption of Site Payment Technology
While site payment issues from study sponsors are no where near resolved, the greater use of site payment technology seems to be contributing to this topic moving in the right direction so sites can be paid on time/frequently, correctly and with appropriate back-up documentation. Study sponsors are recognizing the positive and important role the right site payment technology plays in contributing to site relationships and sustainability.
Greater Alignment With Cross-Functional/Internal Teams During Contract/Budget Negotiations
While only a few years ago site payments within study sponsors were only an afterthought, increasingly we are seeing site payment teams brought into site budget development and negotiations to ensure a streamlined process between what is negotiated with sites and how payments will be administered.
While some of these observed trends are only at their beginning, it is encouraging to see some of them potentially revolutionize the way we do site contract, budget negotiations and payments for clinical trials. Not all hope is lost for these topics after all – the best is yet to come..
To staying connected on the business aspects of clinical trials in 2024 and beyond…
Débora Sobral (Formerly Araujo)
Founder and CEO, ClinBiz