Do you need to make your clinical trial a big success quickly without adding major costs and additional staff? If so, we have what you need. Via our on-site clinical support services, we will put the staff you need on-location at your trial sites. By having staff trained in your product on site at regular intervals, your clinical trial will get the attention it needs and will have the manpower required to move it along quickly.
The likelihood of the success of your medical trial will be very low if the appropriate attention and on-site support is not provided. Physicians and their staff are very busy people, and clinical trials will often fail simply because they keep getting pushed to the “back burner” by the physician(s) or the support staff doesn’t have the time or bandwidth to provide the needed recordation and support. However, having the proper on-site staff can overcome these problems.
Having the right on-site clinical trial support services will provide you the following benefits:
More attention on your product. By having an on-site advocate (i.e. our nurse working for you) there will be a constant reminder for the physician and the physician’s staff. This will give your product the attention it needs. It is very easy for a physician to push your product to the back burner. However, with a person on-site constantly asking to help, it is very difficult for it to be pushed back.
More resources to perform recordation and data entry. In many busy medical practices, lack of trained resources to perform the recordation and data entry can derail or delay a clinical trial. Having an on-site person with the proper training will alleviate this and keep things moving along.
On-site support to perform in-person patient screening. Having someone on-site with the proper access to medical records can completely change how patient recruitment is done. Our nurse assigned to your site will comb through current and past records to find patients that are a good fit for your trial. This alone can cut the time needed for the trial by more than 50%. Additionally, this same nurse can conduct the in-person screening interviews required to get the patient enrolled.
Variable Cost Structure. You could easily staff up to achieve much of what is described here, but if you do you are going to end up with a fixed cost structure that will be very undesirable. By using BHN, you will have a variable cost structure because we only bill you for the days we are on site. This is a huge win for you. If your project is delayed, then you only pay once staff is needed on site. If you have twelve different sites, but only four of them need on-site support then we can cover only the four.
In addition to the above primary benefits you receive by using our national nursing team outlined above, you may also leverage the additional clinical trial support services listed below:
Site Feasibility and Selection. This would be done collaboratively with you.
Institutional Review Board submissions and communication.
Informed consent process with patient. This includes all paperwork and face-to-face interviews, which removes a major burden from the practice’s staff. With this burden removed, things will go much faster.
Subject recruitment. This includes chart review and patient visits to conduct screening interviews to determine if a subject is eligible to participate in the study.
Patient care. This includes conducting interim study visits to track the progress, symptoms, and side effects during the study.
Assist with medical device application/insertion. This includes assisting the physician investigator with insertions, adjustments, removals and progress assessments.
Adverse Events/Serious Adverse Events Capture and Documentation. This includes patient visits and documenting adverse events. Adverse events are collected during patient visits, or may be phoned in by patients. They are documented, and in the case of a serious adverse event, they are reported to the IRB within 24 hours.
Electronic Data Capture. This includes documentation in the practice’s electronic medical records (EMR) system and the Clinical Research Organization’s (CRO’s) systems and keeping the two in sync.
Generating/maintaining source documentation.
Processing/shipping laboratory samples. This turns out to be an extremely critical step given the security and paper work required.
Study closure. We will assist with the closing paperwork, final submissions, and collecting and shipping any residual supplies.
We are able to provide all of the above via our trained national nursing team that is strategically positioned across the country, so we can provide national coverage, enabling us to be on-site in practices on a weekly basis. It is our regular on-site emphasis that makes us unique. We specialize in Urology and ObGyn practices, but are able to work in other general practices and other specialty practices if needed.
What do our customers say?
Our clinical trial was going much slower than planned. We knew the primary reason was the lack of attention by our investigating physicians at several critical trial sites. We also knew we needed to put people on site, but we had no way to staff up quickly. We turned to BHN and they had expereinced staff on site in just a few weeks. As soon as we had BHN staff on site, our enrollment rates skyrocketed and we were back on track.
--VP of New Products at Medical Device Company
Service Quality we drive quality through culture and processes
Quality doesn't just happen. It takes dedicated people committed to a cause that are excited about what they are doing. It also requires processes that are repeatable and well understood. This is what we strive for at BHN, and we achieve it.