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Invoicing customers for Research and Development

and welcome back to part 5 of this crash course on clinical trial coordination and management in part five we're going to be talking about finance and invoicing now if you've watched the previous parts of this crash course you already know that during the study startup the site where ideally you work at and then the Pharma sponsors have agreed upon and signed a contract or budget now the budget items are where finance and invoicing really comes in now different Pharma sponsors can have a different relationship with site and may have a different way of doing this but typically you can send in invoices and budgets and kind of updates at your own pace sometimes every few weeks to sometimes every few months it really depends on the volume of the patients how many patients you were able to recruit on site because a lot of the times until you are able to charge back the expenses to the Pharma sponsors it's your site that has to Bear the expenses firsthand so I'm sure most sites prefer doing it pretty frequently every couple of weeks I used to do it once a month or every second month now having said that it's really important as a child coordinated to know what a budget is so budget is essentially an agreed upon kind of list where you have various items known as budget items and various agreed upon costs now for example the cost of administering a drug can be say let's say for an example a hundred dollars every time a patient comes to visit the cost of PSW Services can be three hundred dollars the cost of trial coordinator preparing for the visit can be five hours at the rate of seventy dollars or a hundred dollars an hour so similarly these are all budget items everything starting from the syringes you use or the pumps you use the nursing hours the phlebotomy hours the any kind of Pharmacy hours physician all of the Manpower as well as all of the tools the logistics the tubing for the blood unless they are providing it to your site it should be a billable item of course most of these you should you know be very on top of your game at the very beginning at the study startup but at the level of the visit once you've had a you know a bunch of visits and you're like okay it's been a month or it's been two months it's important that you highlight all the things that were done anything that wasn't done should not be built for example maybe your patient had like some kind of a reaction and as such a secondary assessment could not be completed maybe you were able to do the Drug Administration but you couldn't do follow up ECG because the patient became too Unwell by that point of course the Pharma sponsor will by now already be aware of it because by now you should have already filed any kind of protocol deviation reports or any kind of adverse event reports so when you are billing them always build them for only things that were actually done and do not build them for the budget items that could not be completed for various reasons similarly for logistics for time and everything maybe you didn't have a nurse on that particular visit because there was no you know actual patient intervention you just had to go through a few questionnaires with the patient for that particular visit don't build a Pharma sponsor for that nursing hour having said that the way you can be very good as at your job is being very meticulous about tracking these things and that's where your documentation again comes into play not everybody can remember at every single visit what happened what didn't happen which one we missed which one we did or you know or additional resources that were required so it's important that when the visits are actually happening you're keeping your notes so every month or every second month when you're sitting down to do your invoicing you're opening up your budget items maybe you're highlighting everything that has to be charged making a total a lot of the time your site might also charge overhead some sites can charge twenty percent thirty percent forty percent overhead which means the institution has some you know general costs of administration and the finance department and stuff so that usually comes as a percentage of whatever you are charging so if you are sending over a five thousand dollar invoice make sure to add whatever your institutional overhead is the overhead will not come as a surprise to the Pharma sponsor because they will already be aware having signed the original contract so the original contract if you remember signed at the study startup was discussed with your institution with your primary investigator with with a legal team or the contracts office as well as the finance office so by now everybody should be on board when you are sending the invoice now after sending in your invoice it can take you know three weeks five weeks eight weeks um depending on the kind of Pharma sponsor to actually get the money it's important a role as part of a project manager or a clinical trial coordinator to kind of follow up and make sure every invoice you have sent has been approved by them and the money has actually come in and entered your cost center or your account for that particular study similarly when you are paying out your own vendors like we had talked about some subcontracts you might have with a certain company to get PSW services to get transport services or to do some of your diagnostic tests you also have to pay them from that same cost center so it's important that you are also making sure all of the invoices you are supposed to receive you are receiving them on time the amounts are matching up to what was agreed upon the dates are matching up and then you are authorizing these payments maybe you need two authorizations one from the coordinator and then one from the investigator so being very timely and not letting things kind of sit is very important in this role because you know sometimes you might feel like oh no now we have this much extra Revenue in our account and the pi might decide to go and hire more Staffing or do some investment projects with that however all of a sudden after you have spent that money you might get like a bunch of invoices you have to pay or a bunch of overhead that has not yet been deducted so that's why it's important to really be as a trial coordinator be on top of the finances pay off all your bills in time a lot of the times people will only Bill you once or twice a year they don't do individual invoicing they kind of wait maybe every quarter or every six months they're gonna send you all of their costs at once so it's important to have that on your calendar of your project and say you know roughly every April these departments are going to send us bills so kind of have money put aside for that or every November the pharmacy department and the vendors are going to send us the bill or every six weeks like check up and make sure that the account the bill you have sent to the Pharma sponsor has arrived a lot of the times the Pharma sponsor don't even want you to send in and you know budget specific invoices unless it's something out of the ordinary they might be able to just track you through the EDC the electronic data capture platform where you know you do the data entry this was done this wasn't done this was done and they will just track it from there automatically calculated and deposit into that account if you want to be a little extra good in your job you can always kind of match the amount they have sent versus the calculation you do and make sure that their calculations are correct and they're not missing out on paying you for anything specific so that's basically it for finance and invoicing um a lot of Institutions won't have you do too much of the hardcore finances you'll just kind of do overviews and make sure all the invoices make sense and then the finance person in the finance department will take care of these things or a senior manager will take care of them but it's important to just be very clear about what items at least what budget items have been completed that you're expecting revenue for and what vendors you are paying out at least be clear on that part as a clinical trial coordinator so that was it for number five in finance and invoicing