Frequently Asked Questions

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For Sponsors

BTC Network is a third party fiscal agent that is solely responsible for negotiating budgets and contracts and finance management on behalf of institutions. BTC Network does not come in contact with any subjects or conduct any work at the institution’s location, therefore should not be considered a part of the institution.

  1. BTC Network is not an SMO. BTC Network acts on behalf of institutions for negotiations, finance management and business development. See NETWORK SERVICES
  2. An SMO is defined by the FDA “refers to an organization that manages clinical study sites on behalf of the Sponsor and/or drug manufacturer.” Or the ladder, “staff involved directly in the conduct of a clinical investigation may include individuals who are not in the direct employ of the investigator. For example, a site management organization (SMO) may hire an investigator to conduct a study and provide the investigator with a study coordinator or nursing staff employed by the SMO. In this situation, the investigator should take steps to ensure that the staff not under his/her direct employ are qualified to perform delegated tasks (see section III.A.1) and have received adequate training on carrying out the delegated tasks and on the nature of the study (see section III.A.2),… A sponsor who retains an SMO shares responsibility for the quality of the work performed by the SMO.”

For Sites

Your first payment is based on when the first subject data is entered within EDC. Once this has been verified by data management or source verified by your CRA (depending on the contract language which was negotiated) the corresponding payment will be on a monthly or quarterly basis. We can estimate the total expected payment based on the cut-off date from when data management verified the EDC entries. The payments take approximately 4-6 weeks to be processed and sent to BTC Network. Once received by BTC Network, payments are verified for accuracy and then wired to sites within 1-2 business days.

You get paid based on entries made within EDC. For some studies, CROs and Sponsors require that sites invoice each visit that occurs at the site. This is not always the case and we push to ensure that all subject visits are reimbursed based on data managements review of EDC entries. The items that typically require invoices are pass-through items (i.e. start-up and pharmacy fees) along with ancillary services and supply purchases.

BTC Network partners itself with research sites on both a financial and contractual level, however we are not bound by the protocol as we are not performing any of the procedures in a clinical capacity. Therefore we cannot be considered part of the institution within the CTA.

There are no additional costs for utilizing our sister company, ClinEdge, for marketing/patient recruitment campaigns. ClinEdge offers a unique platform where they can build a campaign (web-based or print ads) to generate the best results for each site. The fees and expenses for managing the campaign are calculated based on the total budget assigned to a particular study. No out-of-pocket expenses should be seen, unless a site would like to go over the initial budget limit agreed upon within the CTA. If a site decides to go this route, we would recommend getting Sponsor approval for additional funding to reduce any direct expenses to the site.

First and foremost, it’s important to understand that the material presented to the general population has to be very generic and specific at the same time. It cannot show favoritism, coercion, and both the Sponsor and IRB need to approve anything presented through print or web-based ads. In many cases the Sponsor reviewing process for spending funds can take at minimum 4-6 weeks. Then once the Sponsor approval is received the campaign has to be sent to the IRB to get approval. This could take an additional 2-3 weeks dependent upon the Sponsor assigned IRB. Most approval processes take between 2-3 months in total. This keeps Sponsors from approving and paying expenses when they rely on the majority of sites participating on a trial to recruit patients based on internal referrals or their own patient database.

Your advertising budget is what we negotiated with the Sponsor to ensure your site can do some recruiting outside of your patient population. Based on the indication, we were able to get your site the following budget in hopes to generate more leads for your current study and will hopefully fill your database for future studies within the same therapeutic area.

Screen failures are reimbursed in a few different fashions. This is dependent upon what was negotiated within the contract. We always push for ALL screen failures to be reimbursed. If this is approved, we ask that it be at the full cost of the screening visit, including the baseline visit (if applicable). Many times we find that if all screen failures are approved, Sponsors will typically pay on a per procedure basis. In many cases screen failures are paid during the time grant payments are issued. Some Sponsors require invoicing for reimbursement of screen failures and we do what we can to deter the extra leg work for these patients. Should a ratio be applied to screen failure reimbursement, then it is our job to stay on the Sponsors to ensure screen failures are reimbursed in a timely fashion.

This is something we push Sponsors and CROs to ensure all of our sites have this line item within their budget. In many cases, CROs call this the “cost of doing business.” We do not subscribe to that mantra. Price out what you think it would cost to have a regulatory agent or Sponsor auditor on site. Know your PI and study coordinator rates to set aside time during those 2-3 business days the auditor(s) are there. Depending on the phase of the trial and the anticipated enrollment goal for the site, we come up with a reasonable value we think sites should be reimbursed. If this is something that was not present in your budget and the Sponsor or regulatory agency required it, send a formal letter to the Sponsor (on site letterhead) after the audit. In detail, list out what occurred, how much time was spent with the auditors and the number of days on site. For smaller sites, this can be a burden as you will have to shut the office down (meaning not seeing patients) for anonymity purposes and due to the fact that you won’t have the personnel to conduct the audit during a normal work day.

The important thing to remember about this is to renegotiate the line item or request it from the start. We would recommend asking for a Regulatory Agency/Sponsor Not-For-Cause Audit fee. This will cover all spectrums of who can come audit your site. Send a formal letter to the Sponsor (on site letterhead) after the audit. In detail, list out what occurred, how much time was spent with the auditors and the number of days on site.

Payment terms are based on what we negotiated on behalf of the site. You can usually find your payment terms within the CTA under the exhibits which reference the patient budget or in the beginning under payment terms. We always push for sites to receive monthly or at the latest bi-monthly payments.

Payment terms are based on what we negotiated on behalf of the site. You can usually find your payment terms within the CTA under the exhibits which reference the patient budget or in the beginning under payment terms. We always push for sites to receive monthly or at the latest bi-monthly payments.

Payment terms are based on what we negotiated on behalf of the site. You can usually find your payment terms within the CTA under the exhibits which reference the patient budget or in the beginning under payment terms. We always push for sites to receive monthly or at the latest bi-monthly payments.

At the start of the negotiation process we strive to ask for no holdback to be applied. In the event a Sponsor mandates it, we asked that it be reduced to the lowest common denominator. We typically start at 5% and try to land no higher than 10%. Holdback is an archaic system which was instituted during a time when eCRFs had to be visibly verified by a CRA from paper source documents located at the site. Portions of payments would not be issued until the completion of a study to hold sites accountable for completing all data entry (query free and electronically signed) in a timely fashion. Based on the change in modern day technology and where the industry is currently heading, this is an outdated practice and one that we encourage all sites to steer clear of agreeing to for all future studies.

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.

108 Myrtle Street, Quincy, MA 02171  |  P: 857-284-7574

E: newtrials@btcsites.com

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