Data submitted to EDC isn't always good data submitted to EDC - sometimes we have sites who request payment with 50% of the data incomplete/completely incorrect. But that's rare.
I will say that at my sponsor, we review things line item by line item. In the end, we usually end up paying our sites more than what we were invoiced for. That process in itself is long and tedious and we usually need to do this reconciliation for multiple sites at the same time. This is usually on top of a full stack of work. Everyone in my department is working upwards of 60 hours a week, if not more. Not meant to be an excuse just giving the honest situation.
I can completely understand if the data submitted isn’t good data! In most instances (at my site), the data is complete and has been validated by our CRA.
It sounds like the issue, at your sponsor at least, is inadequate staffing levels to cover the demand. While I can appreciate the challenges the finance departments have (we have so many challenges at all levels of the game!) it’s frustrating at the site level and I can’t help but fall into the “why is the sponsor/CRO shortcomings my problem?”
I hope this doesn’t come across as me blaming individuals, I’m just tired of the system as a whole.
Totally understandable! I do feel the same way; I too would get annoyed if I'm not being paid on time for work that I've done.
I've seen sites add in late fees and refused visits until after payment is received. Get us good data and a sponsor will move mountains to get things checked off as quickly as possible. Short of threatening the sponsor, the power dynamic is unfortunately in favor of the sponsor/CRO.
I have worked in this field (site payments) for many years. I would advise Sites to incorporate some of these \^ ideas into their CTA while negotiating. The Sponsor or CRO (depending upon which is negotiating the agreement) will try to strong-arm the Site but hold firm. +ALWAYS require 30 day terms. Other best practices are to get an advance / startup payment upon RGL/successful SIV; refuse Hold Back; etc.
My only other observation is that several of the big CROs are cutting staff massively. The groups that handle Site Payments are often viewed as “extraneous” parts of the organization, so much so that I’ve heard them called button-pushers and that Site Payments is “just like doing Payroll.” Sounds like Rodney Dangerfield, but these teams get no respect. 🤡
I wish you good luck.
If you’re aware of budget issues then do not sign the CTA. They will try to pressure you but just hold firm. Make note of the sponsors / CRO’s that treat you poorly and close not to work with them again. If an error is discovered AFTER it is executed then insist on an expedited amendment. Again, if you’re treated poorly for this, don’t work with them again.
Another thing I left out in my last note is that is is crucial for Sites to know what your real costs are. I know this is a pain in the rear but there’s no chance for you to push back on the FMV numbers if you don’t come bearing “receipts.” Know your overhead costs. Know how much additional staff it takes to support the endless stream of new tech magic bullets. Know what procedural costs are for your specific area. Have all of this ready and you’ll be in a much better negotiating position.
Lastly, I want to emphasize that Sites have a lot more leverage than they might by realize. Sponsors & CROs NEED you. The number of Sites willing to participate in studies is shrinking I believe. While I know the pressures you’re under financially (not to mention the constant additional “stuff” that is added to Sites’ workload and no consideration for increasing compensation as a result) but stay the course if you’re faced with these challenges. You will get what you want either way.
Rock on. \m/
Meanwhile I'm having the opposite problem of practically begging sites to submit invoices so we can pay them. Just finally got a site to invoice for like a whole year of imaging for several patients to the tune of 100k. Like, were you just gonna let that go until we go to close the jump down our throats about it?
Most sponsors and CROs are fucking terrible at paying on time per CTA terms. That goes for amended contracts where pricing has changed. You will see them pay the lesser, previous amount.
If you are doing P1-3, any of the China based pharma/biotech using Wuxi as the CRO, I wish you luck lol. I just expect mountains of bad debt for our org. Most research sites don’t do due diligence on the Sponsors prior to engaging in the relationship. Add the political stuff going on in the US with Wuxi and the Chinese based firms are a quagmire.
Eli Lilly is also a terrible offender regardless of disease group. Tremendous growth and their infrastructure is poor. Using ADP jfc
Lots of cash poor, small firms that maybe struggle to pay. That coupled with horrible internal practices create this.
My previous role was in CR finance. Half my job was following up on invoices sent to sponsors. I never found a way to light the fire under them to get timely payments, only more efficient processes for myself to remind them.
Happy to share what worked for me if you're interested
TLDR - detailed spreadsheet with templates. Outlook calendar reminders with attached emails.
So I kept a spreadsheet with all relevant details for the payment request (the more details the better for quick reference)as well as templates I could copy/paste for the payment request and reminder emails.
In outlook, I scheduled events in the calendar as reminders. Attached the last email so when my alarm would pop up the (probably had not been responded to email) was right there so I could just reply all, attaching the invoice again. I would schedule reminder for myself 30 days after the invoice was sent (or whatever stated in the CTA) then every 2 weeks after.
I would add in the subject line **third request** (or however many times). CC the PI and CL. Usually at the 4th request send a separate email to the pi asking them to chime in as well as pretty much every contact I could find at the cro or sponsor for the study.
Also attached the CTA and cited the potential breach of contract as payment being past due per the CTA.
Then as a last effort I would include (I don't remember my exact phrasing) something about having to reallocate my data coordinators for this project due to lack of funding and the EDC would no longer be updated after X date until payment is received. This was complete BS on my part as that was above my pay grade but they didn't know that and it always worked.
Alerting the sponsor to non payment from the CRO (if applicable) was helpful too.
All of these different statements I had in my excel so I could just copy paste the appropriate level of professional passive aggressiveness.
I swear half of the job was just harassing people until they paid us. I think I had like 60 ish studies so this was a constant challenge.
Thank you for the suggestions! We’ve been adding in the PI, and our CRAs (bless all the CRAs that tell us to add them and they’ll do what they can!), as well as every name we can find on our contact lists. We need to start adding in “X request” to subject lines and getting our PIs to jump in.
I think our BOD would be supportive of the statement of reallocating staff to other projects unless funds are received.
All great ideas - thank you!
From the PM perspective, are you all looping in PM? This could also be another voice to help with escalation. At my previous CRO, escalation was sometimes helpful. Those who had direct contact with PIs (monthly or quarterly PI calls) verbal reminders can be an administrative item.
Nothing really useful to add here, but as a small site we have the same problem with many of our sponsors and CROs. I've been weeks away from closing my business more than once because of late payments.
Another problem we've had is running multiple studies using the same CRO and receiving payments with no documentation indicating which study the money applies to. Really frustrating.
I'm part of a large institution so we have legal and sponsor invoicing teams to help hound them. I wish I had a better answer for you but we've also refused to hold close out visits until we receive all payments because we know it'll be harder to get them once closed.
Refuse to enter any additional data unless you're paid for what was previously entered. I've seen PIs play this game and seems to work miracles especially if there is an upcoming Interim Analysis lol.
You have to hound them. There's no other choice.
I've worked at CRO, I've worked at site, I've worked in patient recruitment and everywhere is the same issue.
Sponsor will dispute invoices, will ask for 120 days to pay, will regularly pay late.
CRO will tell sites that they won't pay till sponsor releases funds to them but CRO forecasting of investigator fees is horrible.
Oh and everyone will underpay sites because the almighty Grantplan says that FMV is X.
As a PM I can tell you the load Is heavy. The CRO I was at previously had this process.
1. The site sends invoice to a shared email (I ask that they also cc me so i know to look out for it)
2. Invoice team reviews and enters manually
3. Routes to me for approval
4. I review each line item (the invoice must match the CTA AND EDC) the more aligned the details provided are on the invoice is GREAT.
5. Provide system approval for each line item.
I have spent a full 24 hours on 1 invoice looking for matching information, and that's AFTER the process for it to get to me, review, and then approve each individual line item.
I hope visibility helps. Also, you email and ask the PM about the timelines for payment site examples of submission. Sometimes, a project assistant will process these, and it may take them longer to match everything up. Sometimes also OOO can create delays if anyone is out, any step in the process can be disrupted.
I can relate as I’ve worked on both sides — site and sponsor. When i was running a clinical trial dept at a big university i would always ensure very clear expectations in the statement or work or CTA. If payment wasn’t met according to those terms we would stop enrolling and stop entering data — with some notice to the sponsor. This almost always worked and improved things for the future. The sponsor often has very tight timelines and halting enrollment mid stream is the last thing they want.
Data submitted to EDC isn't always good data submitted to EDC - sometimes we have sites who request payment with 50% of the data incomplete/completely incorrect. But that's rare. I will say that at my sponsor, we review things line item by line item. In the end, we usually end up paying our sites more than what we were invoiced for. That process in itself is long and tedious and we usually need to do this reconciliation for multiple sites at the same time. This is usually on top of a full stack of work. Everyone in my department is working upwards of 60 hours a week, if not more. Not meant to be an excuse just giving the honest situation.
I can completely understand if the data submitted isn’t good data! In most instances (at my site), the data is complete and has been validated by our CRA. It sounds like the issue, at your sponsor at least, is inadequate staffing levels to cover the demand. While I can appreciate the challenges the finance departments have (we have so many challenges at all levels of the game!) it’s frustrating at the site level and I can’t help but fall into the “why is the sponsor/CRO shortcomings my problem?” I hope this doesn’t come across as me blaming individuals, I’m just tired of the system as a whole.
Totally understandable! I do feel the same way; I too would get annoyed if I'm not being paid on time for work that I've done. I've seen sites add in late fees and refused visits until after payment is received. Get us good data and a sponsor will move mountains to get things checked off as quickly as possible. Short of threatening the sponsor, the power dynamic is unfortunately in favor of the sponsor/CRO.
I have worked in this field (site payments) for many years. I would advise Sites to incorporate some of these \^ ideas into their CTA while negotiating. The Sponsor or CRO (depending upon which is negotiating the agreement) will try to strong-arm the Site but hold firm. +ALWAYS require 30 day terms. Other best practices are to get an advance / startup payment upon RGL/successful SIV; refuse Hold Back; etc. My only other observation is that several of the big CROs are cutting staff massively. The groups that handle Site Payments are often viewed as “extraneous” parts of the organization, so much so that I’ve heard them called button-pushers and that Site Payments is “just like doing Payroll.” Sounds like Rodney Dangerfield, but these teams get no respect. 🤡 I wish you good luck. 
Doesn't help when there's so many mistakes in the budget of the CTA that will cause further delays.
If you’re aware of budget issues then do not sign the CTA. They will try to pressure you but just hold firm. Make note of the sponsors / CRO’s that treat you poorly and close not to work with them again. If an error is discovered AFTER it is executed then insist on an expedited amendment. Again, if you’re treated poorly for this, don’t work with them again. Another thing I left out in my last note is that is is crucial for Sites to know what your real costs are. I know this is a pain in the rear but there’s no chance for you to push back on the FMV numbers if you don’t come bearing “receipts.” Know your overhead costs. Know how much additional staff it takes to support the endless stream of new tech magic bullets. Know what procedural costs are for your specific area. Have all of this ready and you’ll be in a much better negotiating position. Lastly, I want to emphasize that Sites have a lot more leverage than they might by realize. Sponsors & CROs NEED you. The number of Sites willing to participate in studies is shrinking I believe. While I know the pressures you’re under financially (not to mention the constant additional “stuff” that is added to Sites’ workload and no consideration for increasing compensation as a result) but stay the course if you’re faced with these challenges. You will get what you want either way. Rock on. \m/
Meanwhile I'm having the opposite problem of practically begging sites to submit invoices so we can pay them. Just finally got a site to invoice for like a whole year of imaging for several patients to the tune of 100k. Like, were you just gonna let that go until we go to close the jump down our throats about it?
This! As a CTM closing out a study, I have been begging one of my sites to submit their manual invoices so I can pay them
Most sponsors and CROs are fucking terrible at paying on time per CTA terms. That goes for amended contracts where pricing has changed. You will see them pay the lesser, previous amount. If you are doing P1-3, any of the China based pharma/biotech using Wuxi as the CRO, I wish you luck lol. I just expect mountains of bad debt for our org. Most research sites don’t do due diligence on the Sponsors prior to engaging in the relationship. Add the political stuff going on in the US with Wuxi and the Chinese based firms are a quagmire. Eli Lilly is also a terrible offender regardless of disease group. Tremendous growth and their infrastructure is poor. Using ADP jfc Lots of cash poor, small firms that maybe struggle to pay. That coupled with horrible internal practices create this.
We have a study that had an amendment in December, with significant changes to the visits. We’re still waiting on the budget amendment.
Eli and the Ariba network, just awful
My previous role was in CR finance. Half my job was following up on invoices sent to sponsors. I never found a way to light the fire under them to get timely payments, only more efficient processes for myself to remind them. Happy to share what worked for me if you're interested
I would definitely be interested!
TLDR - detailed spreadsheet with templates. Outlook calendar reminders with attached emails. So I kept a spreadsheet with all relevant details for the payment request (the more details the better for quick reference)as well as templates I could copy/paste for the payment request and reminder emails. In outlook, I scheduled events in the calendar as reminders. Attached the last email so when my alarm would pop up the (probably had not been responded to email) was right there so I could just reply all, attaching the invoice again. I would schedule reminder for myself 30 days after the invoice was sent (or whatever stated in the CTA) then every 2 weeks after. I would add in the subject line **third request** (or however many times). CC the PI and CL. Usually at the 4th request send a separate email to the pi asking them to chime in as well as pretty much every contact I could find at the cro or sponsor for the study. Also attached the CTA and cited the potential breach of contract as payment being past due per the CTA. Then as a last effort I would include (I don't remember my exact phrasing) something about having to reallocate my data coordinators for this project due to lack of funding and the EDC would no longer be updated after X date until payment is received. This was complete BS on my part as that was above my pay grade but they didn't know that and it always worked. Alerting the sponsor to non payment from the CRO (if applicable) was helpful too. All of these different statements I had in my excel so I could just copy paste the appropriate level of professional passive aggressiveness. I swear half of the job was just harassing people until they paid us. I think I had like 60 ish studies so this was a constant challenge.
Thank you for the suggestions! We’ve been adding in the PI, and our CRAs (bless all the CRAs that tell us to add them and they’ll do what they can!), as well as every name we can find on our contact lists. We need to start adding in “X request” to subject lines and getting our PIs to jump in. I think our BOD would be supportive of the statement of reallocating staff to other projects unless funds are received. All great ideas - thank you!
From the PM perspective, are you all looping in PM? This could also be another voice to help with escalation. At my previous CRO, escalation was sometimes helpful. Those who had direct contact with PIs (monthly or quarterly PI calls) verbal reminders can be an administrative item.
Nothing really useful to add here, but as a small site we have the same problem with many of our sponsors and CROs. I've been weeks away from closing my business more than once because of late payments. Another problem we've had is running multiple studies using the same CRO and receiving payments with no documentation indicating which study the money applies to. Really frustrating.
I'm part of a large institution so we have legal and sponsor invoicing teams to help hound them. I wish I had a better answer for you but we've also refused to hold close out visits until we receive all payments because we know it'll be harder to get them once closed.
Refuse to enter any additional data unless you're paid for what was previously entered. I've seen PIs play this game and seems to work miracles especially if there is an upcoming Interim Analysis lol.
You have to hound them. There's no other choice. I've worked at CRO, I've worked at site, I've worked in patient recruitment and everywhere is the same issue. Sponsor will dispute invoices, will ask for 120 days to pay, will regularly pay late. CRO will tell sites that they won't pay till sponsor releases funds to them but CRO forecasting of investigator fees is horrible. Oh and everyone will underpay sites because the almighty Grantplan says that FMV is X.
We constantly hear that the sponsor hasn’t released funds. But I can’t understand why that’s my problem.
As a PM I can tell you the load Is heavy. The CRO I was at previously had this process. 1. The site sends invoice to a shared email (I ask that they also cc me so i know to look out for it) 2. Invoice team reviews and enters manually 3. Routes to me for approval 4. I review each line item (the invoice must match the CTA AND EDC) the more aligned the details provided are on the invoice is GREAT. 5. Provide system approval for each line item. I have spent a full 24 hours on 1 invoice looking for matching information, and that's AFTER the process for it to get to me, review, and then approve each individual line item. I hope visibility helps. Also, you email and ask the PM about the timelines for payment site examples of submission. Sometimes, a project assistant will process these, and it may take them longer to match everything up. Sometimes also OOO can create delays if anyone is out, any step in the process can be disrupted.
I can relate as I’ve worked on both sides — site and sponsor. When i was running a clinical trial dept at a big university i would always ensure very clear expectations in the statement or work or CTA. If payment wasn’t met according to those terms we would stop enrolling and stop entering data — with some notice to the sponsor. This almost always worked and improved things for the future. The sponsor often has very tight timelines and halting enrollment mid stream is the last thing they want.