[Q&A] Financing Clinical Trials – Part 2

 If you are negotiating with a CRO and they come back to a budget offer and say they cannot increase it, ask for the request to be escalated to the sponsor. If the CRO still says the budget will not be increased, try requesting a call with the sponsor. On the call, justify your expenses and try to give rationale for your increased budget. If the sponsor is unable to budge and you feel you would be losing money on the study, it might be time to walk away. There is one exception to this rule – new sites. If you are a brand new site or you have a brand new investigator, it might be necessary to operate at a loss to start with just to build up your experience. If you don’t have any studies running, it might be worth it.

 The finance team and the clinical team need to work together in order to ensure that this timeframe is met. Meetings should be held biweekly in order to ensure that all items are being captured. It is also helpful to log all events in CTMS, which will help keep everything organized and will help ensure that nothing is missed. In general, most sponsors and CROs are typically slightly flexible with this time frame, and we have seen them allow for invoices to be submitted outside of the 30 days (however, definitely don’t count on this!).

These costs need to be negotiated within the budget. As Scott discussed in a previous webinar, it is always better to ask for everything up front, as it is always more difficult to get reimbursed later. Some sponsors/CROs will allow for data mining/chart review fees and prescreening log fees if you ask for them. Typically, we have seen sponsors accept around $2,000 – $3,000 for data mining, $25 – $30 per chart for chart review, and $200 – $300 per month for prescreening logs. Costs for follow-up with sponsor would be part of the per-patient budget and should be reflected in the study coordinator fee. We’ve also started to see some sponsors allocate a specific line in the budget for admin costs at $30 – $40 per visit.

 We would recommend beginning the negotiation in writing so that everything is presented formally. If there are a few remaining items or if there is a small window in the per patient amount that you are trying to increase, a phone call may be useful to help you get to the value you are aiming for. Usually the person you are negotiating with does not have the final approval over the budget and a phone call can help win over a contact and convince them to push on their end to get your higher requests approved. Remember that building a good relationship will always work in your favor.

 This is definitely one of the drawbacks to paying PIs on a procedural basis. This model is great for reducing risk to the site, but it can be tricky for the PI. In your initial negotiation, you would determine the per visit procedural costs. We would also recommend requesting an advance payment/refundable start-up of two completed patients. These funds can be used to pay the PI as you are waiting for your regular visit payments to begin. Most PIs will also agree to a monthly payment schedule, which will be easier on your cash flow. If you are enrolling well in the study, we would also recommend reaching out to the sponsor or CRO and asking if payments can be made more frequently due to the number of patients being seen. You can usually justify this by stating that significant costs are being incurred due to the high volume. In our experience, sponsors are much more accommodating to higher enrolling sites.