Below are some questions we received during the presentation. If you have additional questions about the contract and budget process please contact our presenter- Al Peters, at Al@btcsites.com.
- Do you ever pass on a study due to a poor screen fail ratio?
No, recruit up to the SF ratio and then review additional reimbursement requests with the Sponsor. Make sure that you are tracking the SF reasons based on the I/E criteria for when you discuss with the Sponsor. If your site is experiencing high SF, other sites most likely are as well.
- In your experience what do sponsors expect from Sites during the negotiation process?
They expect timely responses, and a full contract turnaround time of 2 weeks. Documentation on site letterhead is very important to have on hand, ready to give to a Sponsor when requested so that the process is not delayed. Typically requested documentation is site overhead policy, breakdown of startup costs, calculations of dry ice reimbursement requests and document archiving.
- Can you briefly explain your process when negotiating a budget?
Once a CTA, budget, and protocol are received we submit our requested budget within 24-48 hours. If we have not heard back from the CRO after 3 days we send a friendly follow up to see if anything additional is needed for their review. Once the CRO sends back the 2nd counter offer we send back our revised requests within 48 hours with all supporting documentation requested and/or needed. By the 3rd round of negotiations if we have not obtained the budget that we can finalize on a call is requested to the CRO to speak with the Sponsor on a call to review the remaining items in further detail in order for them to understand where we are coming from. Once that call is completed the Sponsor study team will review and send back their final offer. At that time we determine whether or not the study is feasible and profitable for our site.
Stay tuned for more webinars in 2017!
About BTC Network
BTC Network is North America’s leading clinical research group. Based just outside of Boston, Massachusetts, our network includes more than 50 multi-therapeutic sites. All BTC research sites collaborate with or are part of private practices, giving us access to over 100,000 patients.